VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1673318
Sex: F
Age:
State: TN

Vax Date: 08/17/2021
Onset Date: 08/20/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Seizure that may have been a PNES seizure.; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3182), via unspecified route of administration, administered in left arm, on 17Aug2021 at 12:00 PM (15-year-old at the time of vaccination), as dose 1, single for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. On 17Aug2021 at 12:00 PM, the patient experienced Seizure that may have been a PNES (psychogenic non-epileptic seizure) seizure. As a result, the patient visited emergency room. The patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination and not tested for covid post vaccination. On an unknown date in 2021, the outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673319
Sex: F
Age:
State: CO

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 09/04/2021
Hospital: Y

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: had a stroke; Right facial paralysis; mouth swelling; mouth numbness and swelling; mouth numbness and swelling, scramble, imbalance; fatigue; left eye pain due unable to close; arm pain; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 13Mar2021 12:45 (Batch/Lot number was not reported) (at the age of 51-years-old) as single dose for covid-19 immunisation. Medical history included known allergies not to food, to some medications. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant drugs included prescribed medication since a long time. On 13Mar2021 the patient experienced right facial paralysis, mouth swelling, mouth numbness and swelling, scramble, imbalance, arm pain, fatigue, after been at the hospital it moved to the left side of face, left eye pain due unable to close. She had a stroke. The patient was hospitalized for 2 days and treatment for the events was received. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability. The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673320
Sex: F
Age:
State: LA

Vax Date: 08/04/2021
Onset Date: 08/08/2021
Rec V Date: 09/04/2021
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: Test Date: 20210818; Test Name: Nasal swab; Test Result: Negative

Allergies:

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

Symptoms: huge blood clots; Period is two weeks early; Period is two weeks early with major cramping; brain fog; extreme bloating; extreme fatigue; headache; arm pain at injection site; weight gain; chest pain; thick sputum; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Aug2021 13:00 (at the age of 37-year-old) (Batch/Lot Number: Fc3180) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store. The patient medical history was not reported. Known allergies: Iodine, codeine. The concomitant medications in 2 weeks were none. The patient previously received bnt162b2 dose 1 at right arm on 28Jan2021 16:00 (Lot number: El9265) as single dose for COVID-19 immunisation. No other vaccine in four weeks. Patient was not pregnant. No COVID prior vaccination. On 08Aug2021 14:30 the patient experienced huge blood clots (medically significant) with outcome of not recovered, period is two weeks early (non-serious) with outcome of not recovered, period is two weeks early with major cramping (non-serious) with outcome of not recovered, brain fog (non-serious) with outcome of not recovered, extreme bloating (non-serious) with outcome of not recovered, extreme fatigue (non-serious) with outcome of not recovered, headache (non-serious) with outcome of not recovered , arm pain at injection site (non-serious) with outcome of not recovered, weight gain (non-serious) with outcome of not recovered, chest pain (non-serious) with outcome of not recovered, thick sputum (non-serious) with outcome of not recovered. The course of events was as follows: Period was two weeks early with major cramping and huge blood clots, brain fog, extreme bloating, extreme fatigue, headache, arm pain at injection site, weight gain and chest pain with thick sputum. The events 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 Sars-cov-2 rapid test (nasal swab): negative on 18Aug2021. Therapeutic measures were taken as a result of the events: antibiotics. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1673321
Sex: F
Age:
State:

Vax Date: 06/07/2021
Onset Date: 06/08/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: heart felt like someone was squeezing it. The pain was so intense that it woke me up in the morning while I was sleeping.; This is a spontaneous report from a non-contactable consumer. A 36-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Batch/Lot number was not reported) (at the age of 36-years-old ) as single dose for covid-19 immunisation. Medical history was none. Concomitant medications included levonorgestrel (MIRENA) taken for an unspecified indication. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no Known allergies. The day after the first injection on 08Jun2021 the patient's heart felt like someone was squeezing it. The pain was so intense that it woke her up in the morning while she was sleeping. About a week later this happened again when she was walking down the stairs. Again, the pain was so intense it stopped her in her tracks. This pain has not occurred again. The event required Physician Office Visit. No treatment was received. For the records, she was active, fit, and healthy. She run and lift weights several times a week, maintain a healthy diet, have a healthy body weight, and was a former college athlete. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Then the patient received the second dose of vaccine on 28Jun2021 (Batch/Lot number was not reported). No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: MIRENA

Current Illness:

ID: 1673322
Sex: F
Age:
State: NJ

Vax Date: 02/18/2021
Onset Date: 04/27/2021
Rec V Date: 09/04/2021
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: Shingles; Itchy; Burning; Bubbly rash; This is a spontaneous report from a contactable nurse (patient, self-reported). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date: 30May2021), via an unspecified route of administration, in Arm Left, on 18Feb2021 (age at vaccination: 54 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date: 31May2021), via an unspecified route of administration, in Arm Left, on 28Jan2021 (age at vaccination: 54 years), as a single dose for COVID-19 immunization. The patient did not received any prior vaccinations within 4 weeks. The patient was listening to the radio, and they said people were reporting an uptick of shingles after getting the COVID 19 vaccine. She had shingles after the vaccine as well as 3 other people she knows on 27Apr2021. It was out of the blue. The patient did not have a prescribing doctor. She got it at work. One of the surgeons she works with was going through shingles now after the vaccine. Her friend's husband also has shingles. Both of theirs happened within 6 months of the shot. She had it exactly 8 weeks after the second shot. She has a procedure done, and post op she noticed a rash around the incision. The procedure was removal of hardware from her lower leg fracture. The incision was not infected. The shingles were surrounding and tracking along the nerves. It was all over her lower surgical leg, around the incision. She had a lower extremity fracture. The shingles were outside of the incision. She didn't get antibiotics. She was prescribed Valacyclovir which cleared it up. She went to the doctor's because she was upset for a post op visit. Her surgery was 12Apr2021, and she went to the doctor with an itchy, burning, bubbly rash on both sides of the incision on 27Apr2021. She was more upset to know she was not alone. She originally thought it was an out of the blue occurrence. But it was because of the stupid vaccine. She was not a fan of this vaccine to begin with. She was forced to do it to keep her job. She 100 % thinks the shingles was related to the vaccine. She had an outbreak of shingles. She told people. She had one coworker say omg the surgeon has shingles after his vaccine too. Her friend at the other place was mandated to get the vaccine or he would be terminated too. It was her friend's husband. He got shingles too. His was later. He was forced later than she was to get the vaccine. She knows both of them live in South Jersey and got both got shots in South Jersey. She doesn't have their information to do reports. The surgeon got his at cooper. Her friend's husband was a pharmacist. The adverse events did not require a visit to emergency room. The events were resulted in physician office. There were not relevant tests. Outcome of the event shingles was recovered on an unspecified date in 2021 and for all other events, it was unknown.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101084542 Same reporter/drug/AE, different patient;US-PFIZER INC-202101085084 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1673323
Sex: F
Age:
State: ID

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/04/2021
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: Severe allergic reaction; headache; tired within 5 minuets; about 30 minuets in it turned to nausea; then throat started to feel tight; wheezing in lungs; Lips tingling; Face tingling; Eyes went itchy; This is a spontaneous report from a contactable consumer. A 28-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Aug2021 15:30 (Batch/Lot number was not reported) (at the age of 28-years-old female ) as single dose for covid-19 immunisation . Medical history included covid-19 from an unknown date and obesity. The patient was not pregnant. Concomitant medications included buspirone 40mgs taken for an unspecified indication; escitalopram 25mgs taken for an unspecified indication; hydroxyzine 10 taken for an unspecified indication. The patient had known allergies to allergies to Lamictal, abilify and strattera. On 20Aug2021 at 15:45 the patient had severe allergic reaction. Headache and tired within 5 minuets then about 30 minuets in it turned to nausea then throat started to feel tight with wheezing in lungs, lips and face went tingling and eyes went itchy. The events resulted in Emergency room/department or urgent care. The patient was treated with Iv benadryl, stairoid, histamine uptake, ep shot. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.

Other Meds: BUSPIRONE; ESCITALOPRAM; HYDROXYZINE

Current Illness:

ID: 1673324
Sex: F
Age:
State: TX

Vax Date: 07/03/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown; Comments: Unknown

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Major breakdown; was diagnosed with a 'behavior' disorder; suffering and I am very upset; got worse; This is a spontaneous report from a contactable consumer (patient reported for herself). A 44-year-old female patient received bnt162b2 (PFIZER COVID VACCINE, Solution for injection, lot number: EW0181), via an unspecified route of administration on 03Jul2021 (age at the vaccination 44-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date 2021, the patient had a major breakdown, and the patient was diagnosed with a 'behavior' disorder (Not appropriately clarified hence disorder captured as event) due to Pfizer vaccine. The patient stated that it got worse and, the patient was rush to the hospital and blood work done all kind of stuff. The patient asked another question patient want to file a lawsuit as, the patient stated that "suffering and I am very upset". The patient lab test which included blood work was unknown on an unknown date 2021. The patient had taken a lots of treatment fostair 6 steroid was what the patient had but it was not working. That was steroid (unspecified). The medicine that patient had was steroid and the cream (unspecified), but it did not work for any way for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673325
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Covid-19; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Both of them are positive (confirmed as COVID positive); Both of them are positive (confirmed as COVID positive); This is a spontaneous report from a Pfizer Sponsored Program of Pfizer via a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date, after receiving first dose of vaccination, patient was tested positive for COVID-19. On an unspecified date patient underwent lab test of COVID and tested positive. Patient was due for second dose on the date of report and asked if she could take the dose. Outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673326
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: I could have blood clots; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: FA7484) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that: "I could have blood clots" on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1673327
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: The next day on 07Apr21 my daughter started having syncope episodes. They have gotten increasingly worse since then; This is a spontaneous report from a contactable consumer (parent). A 16-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as dose 1, single; then dose 2 via an unspecified route of administration, administered in Arm Left on unspecified date (Batch/Lot number was not reported) as dose 2, single (at the age of 16 years) for covid-19 immunisation. The patient's medical history included covid-19 (prior to vaccination)from an unknown date and unknown if ongoing. Concomitant medications included lurasidone hydrochloride (LATUDA); omeprazole (OMEPRAZOLE); propranolol (PROPANOLOL [PROPRANOLOL]); riboflavin (RIBOFLAVIN); magnesium oxide (MAGNESIUM OXIDE); trazodone (TRAZODONE); ethinylestradiol, norethisterone acetate (LOESTRIN), all were taken for an unspecified indication, start and stop date were not reported. The patient previously took keppra [levetiracetam] and amoxicillin and had allergies (known allergies to Keppra and amoxicillin). The patient experienced the next day (reported as 07Apr21) patient started having syncope episodes, they have gotten increasingly worse since then on unspecified date in 2021. It was reported that the patient was hospitalized for 3 days due to the event. It was also reported that the event resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was not recovered. The patient was not tested for Covid-19 post vaccination. The lot number for vaccine [BNT162B2], was not provided and will be requested during follow-up.

Other Meds: LATUDA; OMEPRAZOLE; PROPANOLOL [PROPRANOLOL]; RIBOFLAVIN; MAGNESIUM OXIDE; TRAZODONE; LOESTRIN

Current Illness:

ID: 1673328
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Covid; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: not being able to breathe; Runny nose; congestion; fever; headache; feeling of being sick; flu like symptoms; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included vitiligo. There were no concomitant medications. 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 experienced runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms on an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on an unknown date. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of runny nose, congestion, fever, headache, not being able to breathe, feeling of being sick and flu like symptoms (Pain killers, flu medicine). Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673329
Sex: F
Age:
State: CA

Vax Date: 03/03/2021
Onset Date: 03/31/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: Pregnancy test; Test Result: Positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: The caller got the first vaccine and then ended up getting pregnant in February 2021; heavy excessive vaginal bleeding; Dizziness; nausea; feeling sick; Miscarriage; This is a spontaneous report from a contactable consumer (patient herself). This consumer or other non HCP reported information for both mother and fetus/baby. This is maternal report. A 33-years-old pregnant female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6199; Expiration Date: Jun2021) via an unspecified route of administration, administered in Arm Left on 03Mar2021 as single dose for COVID-19 immunization. Patient was pregnant at the time of vaccination. Medical history included hypertension and obesity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, the caller was calling about the Pfizer COVID 19 vaccine. The caller got the first vaccine and then ended up getting pregnant in February 2021. The caller realized she was pregnant in Feb2021 towards the end of the month, she had some blood work done and it said she was pregnant. On 30Mar2021 the caller went to her OB/GYN to see how the baby was doing and said they couldn't find the heart beat. By March 2021 the caller had to take her second dose and when she did she had a miscarriage right after on 31Mar2021; when they could not find the baby's heartbeat. The caller started feeling sick and went to the emergency room and they didn't know if it was from the miscarriage or not. The caller has been having side effects- extensive bleeding and a lot of blood clots with her period on an unspecified date in Aug2021; for a whole month. The caller called her primary care provider and when she went to the doctor she got a lot of tests done. The tests showed that the caller didn't have a tube pregnancy when she went to the emergency room to make sure it was fine. The patient did an ultrasound and blood tests and it was normal, they just said it was a miscarriage. The caller was so sick with the side effects of the miscarriage. The caller had so much dizziness she couldn't get out of bed and felt like she couldn't walk. Everything was moving, the caller was moving and everything was still and she felt dizzy on 31Mar2021. Patient also experienced nausea on same day 31Mar2021. The caller has had her period longer than 3 weeks. The caller saw online that there were other people with long periods. The heavy excessive vaginal bleeding started this month. After the miscarriage the caller went to he doctor and they checked her tubes and uterus. Everything was fine and nothing was abnormal. When the caller's period was longer than 3-4 weeks, the caller started thinking what was going on now. The caller's friend called her and said she has had a long period too. The caller was concerned because she has had her period almost a month now. At first the caller thought it was a normal long period after the miscarriage. It happened in March and then April and May was whatever. The miscarriage was not as even heavy as this month. The caller's vaginal bleeding starts slowing down and then comes in heavy again. Due to the events miscarriage, heavy excessive vaginal bleeding, nausea, dizziness and feeling sick the patient required to visit emergency room and physician office. The caller had tests on her heart on 19Apr2021 to make sure everything was okay and it was normal, that's when she saw the cardiologist. The caller went to the hospital a few days later to make sure things were okay, the caller thinks this was on 04Apr2021 or 05Apr2021. The patient underwent lab tests and procedures which included pregnancy test: positive on Feb2021. The outcome of events heavy excessive vaginal bleeding, nausea, dizziness and feeling sick was not recovered while outcome of miscarriage was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673330
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: what is in this COVID vaccine that's making the Xeljanz not work for me anymore; This is a spontaneous report from contactable consumer. This 72-year-old female contactable consumer (patient) reported for self that received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (at 72-year-old), as dose number unknown, single for COVID-19 immunization and tofacitinib citrate (xeljanz) at an unknown dose for unknown indication. The patient's medical history and concomitant medications were not reported. On an unknown date the patient complained that COVID vaccine made the Xeljanz not work for patient anymore It was mentioned that patient was on Xeljanz, she called in saying that she recently got her COVID shot and now the Xeljanz was not working. Consumer stated that she had been taking Xeljanz for few years and everything was going fine, she had no problem after she took the COVID shot, the Xeljanz has stopped working, She had been in so much pain to the point where you can barely walk sometimes, she had arthritis (Intent: Indication). She wondered if what was in this COVID vaccine that's making the Xeljanz not work for her anymore, since they were made by the same company. Consumer was provided with the number of Pfizer Medical Information Department. The event outcome was unknown. PSCC Communication: PC Filed. QR comment: CEP ID was not available over the call, hence CEP name was captured as Xelsource. Is there a Product Complaint: Yes Description of Product Complaint: Call was transferred from Xelsource by withheld. Transferring agent stated, "I do have a patient on the backline who have couple of question regarding the Pfizer. She is on Xeljanz, she called in saying that she recently got her COVID shot and now the Xeljanz is not working, she just had a couple of questions, I do have her on the back line." Consumer stated, "I have been taking Xeljanz for few years and everything was going fine, no problem after I took the COVID shot, the Xeljanz has stopped working, I have been in so much pain to the point where you can barely walk sometimes, I have arthritis (Intent: Indication). I was wondering what is in this COVID vaccine that's making the Xeljanz not work for me anymore, since they are made by the same company." Limited information was available over the call. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673331
Sex: M
Age:
State: IA

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 09/04/2021
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: This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient. This is report one of two. Patient is client of caller. A 47-year-old male patient received (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 13-Apr-2021 as DOSE 3 (Age at vaccination 47-year-old), SINGLE for COVID-19 immunisation; COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 19-Aug-2021 at 16:15 (Batch/Lot Number: 017C21A; Expiration Date: 19-Oct-2021) on 19-Aug-2021 at 16:15, at DOSE NUMBER UNKNOWN, 0.5 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine received as (BNT162B2, Batch/Lot number ER2613) via an unspecified route of administration on 22-Mar-2021 as DOSE 1 and Dose 2, SINGLE for COVID-19 immunisation. On 13-Apr-2021, The patient experienced two doses on one day in 22-Mar2-021 and a third dose 13-Apr-2021 and patient administered Moderna vaccine after the Pfizer COVID 19 on 19-Aug-2021 at 16:15. Warm transfer with Pfizer Medical Information INT-Withheld Call was transferred from (withheld) with Pfizer Customer Service. Pharmacist reporting, she had a patient who received three doses of the Pfizer COVID 19 vaccine: two doses on one day in 22-Mar-2021 and a third dose 13-Apr-2021. Reports yesterday the patient came to the pharmacy and the patient stated he had not had a COVID vaccination, so the pharmacist administered another dose of the Moderna COVID 19 vaccine. Caller confirmed information provided by transfer agent. Provides information on the Pfizer vaccinations from a database they can access. When ask for seriousness of these events caller rates them medially significant. When ask for causality, caller states no, unrelated. Adds the patient's wife came in and it is the same exact story with her. She had the same vaccinations on the same days as her husband. A clone report is created to document the wife's experience. Call was transferred by Pfizer Customer Service. Call warm transferred to Agent: Potential AE duplicate. E-transmitting AE report for review. Caller reported that one patient received 3 doses of the Pfizer COVID-19 vaccine. The 47-year-old male patient received 2 doses of the Pfizer BioNTech COVID-19 vaccine last 22-Mar-2021 and the third dose on 13-Apr-2021. The patient according to the caller "came to their pharmacy yesterday and they only ha Moderna". Caller stated that "the patient informed them that he had not previously received any COVID-19 vaccine". The patient as stated by caller wanted to know if they should receive another dose of Moderna. Caller wanted to know if there is any information on mixing the 2 brands of vaccine. Disclaimer provided. Spoke from attached document. The CDC's Advisory Committee on Immunization Practices (ACIP) provides recommendations regarding the routine administration of vaccines to children and adults. The ACIP has released interim clinical considerations for the use of Pfizer-BioNTech COVID-19 Vaccine. Regarding interchangeability of COVID-19 vaccines, the following is stated: Any currently FDA-authorized COVID-19 vaccine can be used when indicated; ACIP does not state a product preference. However, COVID-19 vaccines are not interchangeable. For mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna): Data on the safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product. In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 = 2 weeks after receipt of the second dose of an mRNA vaccine." Sent document via email as preferred by caller. Survey not offered as caller was warm transferred. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events off label use, Extra dose administered, Interchange of vaccine products and the administration of the vaccine cannot be excluded.

Other Meds:

Current Illness:

ID: 1673332
Sex: F
Age:
State: LA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/04/2021
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: Right toes turned solid purple/blue 2 hours after shot.; No clot but blood flow restricted.; Feet always feel cold and ache; Feet always feel cold and ache/Toes hurt to walk on.; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Aug2021 17:00 (Batch/Lot Number: FA7485) (at the age of 39-years-old ) as single dose for covid-19 immunisation. The patient had received the first dose of vaccine on 22Jul2021 12:00 AM in Left arm (Lot number EN0180). Medical history was none. The patient was not pregnant. 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. Concomitant drugs included vitamins. Two hours after shot on 12Aug2021 at 19:00 the patient experienced right toes turned solid purple/blue. Went to ER. No clot but blood flow restricted. Symptoms continued to come back 10 days after. Feet always felt cold and ache. Toes hurt to walk on. It was reported that the events resulted in Emergency room/department or urgent care, disability or permanent damage. . Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1673333
Sex: F
Age:
State:

Vax Date: 08/20/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210821; Test Name: Temperature; Result Unstructured Data: Test Result:99 degrees; Test Date: 20210822; Test Name: Temperature; Result Unstructured Data: Test Result:101+ degrees; Test Date: 20210823; Test Name: Temperature; Result Unstructured Data: Test Result:Around 101 degrees

Allergies:

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

Symptoms: Pressure headache; Chills; Had 99 degrees temperature on Saturday (21Aug2021)/On Sunday (22Aug2021), caller's temperature was at 101+ degrees/Today (23Aug2021), her temperature was still at around 101 degrees; Arm was hurting a little; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pressure headache on 23Aug2021, chills on 22Aug2021, arm was hurting a little on Aug2021, had 99 degrees temperature on Saturday (21aug2021)/on Sunday (22aug2021), caller's temperature was at 101+ degrees/today (23aug2021), her temperature was still at around 101 degrees on 21Aug2021. The patient underwent lab tests and procedures which included body temperature: 99 degrees on 21Aug2021, body temperature: 101+ degrees on 22Aug2021, body temperature: around 101 degrees on 23Aug2021. The outcome of the event pyrexia was not recovered, the outcome of the events headache, chills, pain in extremity was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673334
Sex: M
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/20/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210821; Test Name: fever; Result Unstructured Data: Test Result:102?-104? Fahrenheit; Comments: with one of those ear thermometers

Allergies:

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

Symptoms: feeling off; icky" although he "could still move around; fever; sore arm; This is a spontaneous report from a non-contactable consumer (patient). This 32-year-old male consumer received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm on 19Aug2021 14:00 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021 patient experienced sore arm, on 21Aug2021 feeling, icky" although he "could still move around, fever of recovering. The patient underwent lab tests and procedures which included pyrexia: 102-104 fahrenheit on 21Aug2021 with one of those ear thermometers. Therapeutic measures were taken as a result of fever took Tylenol extra strength and Advil liquid gels which helped to knock his fever down. Caller said he has heard rumors that symptoms are only "suppose to last two days" and so asked how long these symptoms will last? response received saying that fever and sore arm were both reported side effects. Informed caller that "In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter", emphasizing that a specific time frame is not noted for specific side effects. Encouraged caller to reach to his doctor for any symptoms that are prolonged or are worrisome to him for medical evaluation. The outcome for all events was unknown except fever it was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673335
Sex: U
Age:
State:

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/04/2021
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: Discomfort; a little tingling in my mouth on my side, on my right side, tingling on my lips; little blurriness on my right eye; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Aug2021 (Lot Number: FC3180) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 17Jul2021 (lot number: FA6780) as dose 1, single for covid-19 immunisation. The patient took the vaccine about two hours ago and was ok but about may be 40 minutes ago from the time of reporting, the patient had just a some discomfort and a little tingling in the mouth on the side, on the right side, tingling on the lips and a little blurriness on the right eye. The patient did not know if this bear off or should the patient give it some time or should go somewhere. The patient stated this was the second shot and that was the concern. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673336
Sex: M
Age:
State: CA

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 09/04/2021
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: bumps feel hot an itchy like a mosquito bite; he noticed bumps in his legs; itchy like a mosquito bite; This is a spontaneous report from a contactable consumer. This is the 2nd case out of 2 cases. A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 20Aug2021 (age at vaccination 46 years) as dose 1, single for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. On 21Aug2021 the patient experienced bumps feel hot an itchy like a mosquito bite, he noticed bumps in his legs, itchy like a mosquito bite. Reporter stated, noticed 6 bumps on his legs, wrist and it started itching more, bumps feel hot and itchy like a mosquito bite. Reporters husband (consumer) received his Pfizer Covid-19 vaccine first shot yesterday around the same time and his side effects were between 12:30 to 2:00 am last night, he noticed bumps in his legs when he went to the restaurant it started itching and when he went to bed, he started itching more and noticed 6 bumps on his legs and wrist, bumps feel hot an itchy like a mosquito bite. She gave answer to his questions. The patient did not receive any treatment for reported events. The outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1673337
Sex: F
Age:
State:

Vax Date: 08/15/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: complaints of cold; sore throat; coughing up dark brown phlegm; extreme headache; nausea; feels weak; feels really sick; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that after vaccine, she was fine for two to three days. But, after 2-3 days of vaccination, on an unspecified date in Aug2021, patient started having complaints of cold, sore throat, coughing up dark brown phlegm, extreme headache, nausea, feels weak, and feels really sick and was very tired. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673338
Sex: F
Age:
State: VT

Vax Date: 06/01/2021
Onset Date: 08/17/2021
Rec V Date: 09/04/2021
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: Test Date: 20210817; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 202107; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210817; Test Name: COVID-19 PCR test; Test Result: Positive

Allergies:

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

Symptoms: Tested positive to COVID 19 on both an antigen and PCR test; Tested positive to COVID 19 on both an antigen and PCR test; This is a spontaneous report from a contactable consumer. A 13-year-old female patient received BNT162B2 (COMIRNATY; solution for injection), via an unspecified route of administration in Jun2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient received her 2nd dose of BNT162B2 in mid Jun2021 and she tested positive on both an antigen and PCR test on 17Aug2021 while traveling in Ireland. The patient was asymptomatic. She had a previous PCR test in Jul2021 that was negative. The outcome of the event was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673339
Sex: M
Age:
State: FL

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: feel sleepy; headache; body ache; feels weakness; This is a spontaneous report received from a contactable consumer(patient). A male patient received BNT162B2 (COMIRNATY- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 16Aug2021 night, at dose1, 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 made by Pfizer on Monday night of last week, 12 hours later on 17Aug2021 he began to feel sleepy, headache and body ache, today he still had a headache and felt weakness, the patient wants to know if this is normal. He has been taking serum (PENDING CLARIFICATION). The outcome of the events for feel sleepy and body ache were unknown while for headache and body ache were not recovered at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673340
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: he had diabetes; This is a spontaneous report from a Pfizer-sponsored Regulatory Authority Support. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on unspecified date at unknown DOSE 1, SINGLE for COVID-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date at unknown DOSE 2, SINGLE for COVID-19 immunization. No medical history reported. No concomitant medications. He stated that he was confused in regards with Pfizer's general plan. He pointed to the 3rd dose/booster if they could get it because they were informed that after 12 months getting the 2nd dose they will be receiving the 3rd dose but up to now they didn't receive it. (Withheld) is aggravated already in regards to what happened and he stated that he wants to go to the media to inform people about Pfizers general plan because he had diabetes and his wife had a polycystic condition. While talking to the representative she stated that she thinks she can not help it since he was in the original trial and we were in the clinical trial. The outcome of Event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673341
Sex: F
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: first dose of the vaccine on 02Aug2021 and her second dose on 17Aug2021; she can't sleep; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for herself) communicated to Pfizer sponsored Program. A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 17Aug2021 (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on 02Aug2021, as single for covid-19 immunisation. On an unspecified date in Aug2021, the patient cannot sleep. Patient stated she received her first dose of the vaccine on 02Aug2021 and her second dose on 17Aug2021 and wanted to know if that was ok. She stated she received the first vaccine then went back and got her second at 2 weeks and one day and she was not sure how this happened because (withheld) did not say a word that she was there early. She stated she cannot sleep and should she be freaked out. This case was reported as non-Serious. The patient outcome of the event she cannot sleep was unknown at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673342
Sex: M
Age:
State: HI

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/04/2021
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: Arm is little bit sore where I got the shot; pain in my arm where they give me the shot and it was sore; I noticed like a lump, not at the injection site where I got the shot. It is more like on my collar bone area, my shoulder collar bone area; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3181), via an unspecified route of administration in right arm, on 23Aug2021 (at the age of 42-year old) as dose 1, single for COVID-19 immunisation. Medical history included High Blood Pressure from an unknown date. Concomitant medication included enalapril maleate (ENALPRIN) taken for hypertension. On 23Aug2021, after vaccination, he experienced little bit sore where he got the shot, in his right arm and also he noticed something like a lump, not at the injection site where he got the shot. It was more likely on his shoulder collar bone area. No treatment was given in response to the events. The patient was not sure if the events was related to the shot. The outcome of the events was unknown.

Other Meds: ENALPRIN

Current Illness:

ID: 1673343
Sex: M
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: Caller wanted to file lawsuit against Pfizer for getting covid but had received the covid vaccine; Caller wanted to file lawsuit against Pfizer for getting covid but had received the covid vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient got COVID. It was reported that the patient wanted to file lawsuit against Pfizer for getting COVID but had received the COVID vaccine. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. Outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673344
Sex: M
Age:
State:

Vax Date: 03/03/2021
Onset Date: 05/01/2021
Rec V Date: 09/04/2021
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: I am facing problem with fatigue and memory few things/ The next thing was the memory problem. Started about a month ago and they are increasing.; I am facing problem with fatigue and memory few things/ The fatigue gradually increase after the second shot. Starting, About the three month ago and it continued since then till now; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ENG201, expiration date was not reported), via an unspecified route of administration, in left shoulder, on 03Mar2021 (at the age of 73-years-old), at dose 2, single for covid-19 immunization. Medical history included multiple sclerosis from 40 years and trigeminal neuralgia. Concomitant medications included ocrelizumab (OCREVUS) for multiple sclerosis; carbamazepine for trigeminal neuralgia; fampridine (DALFAMPRIDINE); finasteride; terazosin; levothyroxine; atorvastatin; colecalciferol (VITAMIN D); cyanocobalamin (VIT B12); duloxetine; metoprolol succinate; calcium citrate; acetylsalicylic acid (ASPIRINE) (low dose aspirin); thiamine (VITAMIN B1); krill oil (OMEGA 3 KRILL); biotin; botulinum toxin type a (BOTOX); lisinopril; Montelukast; iron; folic acid; hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), multi - vitamin gummies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJO686, expiration date was not reported), via an unspecified route of administration, in left shoulder, on 10Feb2021 (at the age of 73-years-old), at dose 1, single for covid-19 immunization. The patient experienced problem with fatigue and memory few things; the fatigue gradually increased from three months (May2021) after the second shot of vaccination and it continued since the time of report. The memory problem started about a month ago (Jul2021) and they are increasing at the time of report. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: OCREVUS; CARBAMAZEPINE; DALFAMPRIDINE; FINASTERIDE; TERAZOSIN; LEVOTHYROXINE; ATORVASTATIN; VITAMIN D [COLECALCIFEROL]; VIT B12; DULOXETINE; METOPROLOL SUCCINATE; CALCIUM CITRATE; ASPIRINE; VITAMIN B1 [THIAMINE]; OMEGA 3 KRILL; BIOTIN; BOTO

Current Illness:

ID: 1673345
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: My granddaughters other grandmother went bald from it; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was reported that, reporter granddaughters other grandmother went bald from it, and a friend whose hair fell out the back, and another friend who goes to the beauty shop, and the beautician said people are complaining left and right about their hair. The outcome of the event was unknown. The lot number was not provided. Information on lot number has been requested during follow up.

Other Meds:

Current Illness:

ID: 1673346
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: I have a friend whose hair fell out the back; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (her friend) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced "I have a friend whose hair fell out the back" on an unspecified date. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673347
Sex: F
Age:
State: FL

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:98; Comments: it's 98 something; Test Name: Weight; Result Unstructured Data: Test Result: gained; Comments: I gained weight that's really weird its like about 145, 150 in between there; Test Name: Weight; Result Unstructured Data: Test Result:145; Comments: I gained weight that's really weird its like about 145, 150 in between there; Test Name: Weight; Result Unstructured Data: Test Result: 150 in between there; Comments: I gained weight that's really weird its like about 145, 150 in between there.

Allergies:

Symptom List: Nausea

Symptoms: Traumatic brain injury; Muscle pain; I am having like a higher fever; Pain of the joints, the muscle; I have pain all the time; I have excruciating pain because I have a bad back; It's total body aches and it pains like a flu; Redness and swelling; I gained weight that's really weird; Pain of the joints, the muscle; I have pain all the time; It's total body aches and it pains like a flu; Redness and swelling; Loose stools; This is a spontaneous report from a contactable other HCP (Patient herself). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FA7W8U; Expiration date: unknown) dose 1 via intramuscular route in arm left on 10Aug2021 (at age of 61-years-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient was taking medication called Methocarbamol or the American name for it Robaxin 500mg (Not appropriately clarified if consumer was taking Methocarbamol or Robaxin, hence not captured in tab) as concomitant medication. Historical vaccine included Flu shot taken on an unspecified date; 15 years ago, she had a reaction to a Flu Shot (Unspecified Flu Shot) that she give out at her job. Consumer (Retired Nurse) stated that, she had the shot 10 days ago, she was having all kinds of side effects that were not good, did not want to get the COVID vaccination. So now unfortunately she was experiencing a lot of the side effects from the first shot alright that was about 10 days ago. It was reported that, on an unspecified date the, patient experienced traumatic brain injury she had muscle pain, at the injection site (Not clarified). She had a little bit of loose stool, after in regards to the pain of the joints the muscle, she had pain all the time, meaning having excruciating pain because she have a bad back, so this pain was a lot worse, it was not specifically arm pain where she had the injection but it was total body aches and it pains like a flu, like she had a flu before. So she was saying basically with the exception of the injection site, redness and swelling (Further clarification was unknown if consumer had redness and swelling, hence captured as event). She had colonoscopy and gynecological testing (Clarification unknown), so it was nothing like relating to that, so the only thing she said, it must be related to the first injection. She gained weight that was really weird it was like about 145, 150 in between there. The patient underwent lab tests and procedures which included body temperature: 98 something on an unspecified date, weight: gained; gained weight that's really weird it's like about 145, 150 in between there. The outcome of all events was unknown.; Sender's Comments: As there is limited information in the case provided, the causal association between the event traumatic brain injury and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673348
Sex: M
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/22/2021
Rec V Date: 09/04/2021
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: He woke up today with a massive headache; I have a headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient experienced massive headache on 22Aug2021, 3 days after the first dose of vaccination. Patient stated it was said to take Tylenol only if there is headache. Patient enquired whether he could take Excedrin for a headache. The event was treated with Tylenol. The outcome of the event was unknown. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673349
Sex: F
Age:
State: MN

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital: Y

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

Lab Data: Test Name: Angio; Result Unstructured Data: Test Result:Unknown result; Test Name: cholesterol; Result Unstructured Data: Test Result:Poor; Comments: I was poor in cholesterol; Test Name: CT; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: It give me a massive blood clot in my right coronary artery in my heart that leads to a massive heart attack; I developed blood clot in my heart; It give me a massive blood clot in my right coronary artery in my heart that leads to a massive heart attack; I developed blood clot in my heart; I was poor in cholesterol; This is a spontaneous report from a contactable Other HCP. A 48-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration, administered in Arm Right on 05May2021 as a single dose for COVID-19 immunization (at the age of 48-years-old). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration, administered in Arm Right on 14Apr2021 as a single dose for COVID-19 immunization (at the age of 48-years-old). On an unspecified date, consumer stated that, "It give me a massive blood clot in my right coronary artery in my heart that leads to a massive heart attack and I have 3 strands now in my heart, I have lipocide 'not clear' and none of my labs were done for my heart attack, like I was poor in cholesterol and crap you know and when they did the CT and Angio whatever test they did, they did the dial of the heart and not prompt. I have a perfectly healthy heart and none of my laboratories made sense they lead to throwing or having a heart attack and when they went in to place the strands it was all blood clotted in there so it wasn't like attack. So I developed blood clot in my heart." Consumer stated, "I was really admit to the hospital for 5 days and I got 3 strands in my heart, now like treatment and now I am on medicine for the rest of my life because of this." The patient underwent lab tests and procedures which included angiogram: unknown result, blood cholesterol: poor (I was poor in cholesterol), and computerised tomogram: unknown result on an unspecified date. Therapeutic measures were taken as a result of it give me a massive blood clot in my right coronary artery in my heart that leads to a massive heart attack; i developed blood clot in my heart (myocardial infarction), it give me a massive blood clot in my right coronary artery in my heart that leads to a massive heart attack; i developed blood clot in my heart (thrombosis). The outcome of all the events was unknown.; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events myocardial infarction, poor cholesterol, thrombosis and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673350
Sex: U
Age:
State:

Vax Date: 08/17/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: red rashes over my arms, in my elbows, in my face; red rashes on arms, face and elbows, and her arms and face were also itching badly; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; swollen and sore and it felt warm to the touch, but now it seems the swelling is down; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation and experienced arm was just a little stiff. The patient got the vaccine and in Aug2021 was having these red rashes on arms, face and elbows, and her arms and face were also itching badly. She wanted to get an idea how long this rash will last. The arm was a little swollen and sore, and felt warm to the touch, but at the time of reporting it seemed that the swelling was down, arm was cool, but the rash. The outcome of feeling of warmth was recovered in Aug2021, outcome of swelling was recovering, and outcome of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673351
Sex: F
Age:
State: TX

Vax Date: 04/30/2021
Onset Date: 05/05/2021
Rec V Date: 09/04/2021
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: Irregular menstrual cycle, right hemorrhagic ovarian cyst; Irregular menstrual cycle, right hemorrhagic ovarian cyst; This is a spontaneous report from a contactable Other HCP (patient). A 30-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 30Apr2021 15:30 (Batch/Lot Number: Er8731) age at vaccination of 30-years-old, as single dose, for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced irregular menstrual cycle and right hemorrhagic ovarian cyst on 05May2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken and included prescription of birth control for ovarian cyst. Facility type vaccine: Pharmacy or Drug Store. 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 was not recovered from the events.; Sender's Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1673352
Sex: F
Age:
State:

Vax Date: 07/30/2021
Onset Date: 08/15/2021
Rec V Date: 09/04/2021
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: she injured her back; This is a spontaneous report from a Pfizer-sponsored Regulatory Authority Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0164) dose 1 via an unspecified route of administration on 30Jul2021 as single dose for Covid-19 Immunisation. The patient medical history and concomitant medications were was not reported. On 15Aug2021, she injured her back and she was under different medication such as steroid (Intent: treatment), now she is supposed to get her second dose on 18Aug2021 however that needs to be canceled because she is still under medication (treatment) she was schedule for the second dose on 25Aug2021, this coming Wednesday however she thinks she is still unable to make it Wednesday. She was still worried about her condition (Clarification unknown). She was on a lot of medications she does not know if she could be on these medicines when she got the vaccine she was taking 'Mobic' (Not clarified) now which is anti-inflammatory, she thinks and steroid 'Dosepak', she finished steroid 'Dosepak' today, she needed to move it (second dose) ahead a little bit because of the medication. She was seeking for advice. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1673353
Sex: F
Age:
State: WA

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: Test Date: 20210822; Test Name: low grade fever; Result Unstructured Data: Test Result:99.1

Allergies:

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

Symptoms: low grade fever last night of 99.1; felt like balloons, retaining water/weird feeling; That night her legs were really sore and last night her legs were in a lot of pain; both legs being swollen; large indentations like she was retaining water and they were pretty bad last night and her legs felt like balloons; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3183), via an unspecified route on 21Aug2021 (at the age of 38-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included COVID-19 on Feb2020, immunocompromised and had Major Surgery (half of her kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice) kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice on 18May2021. The patient concomitant medications included HPV VACCINE Injection on 20Aug2021 for unspecified indication. On 21Aug2021, the patient experienced night her legs were really sore and last night her legs were in a lot of pain. They felt like balloons, retaining water and this morning when she checked her socks she had sock lines- she took a bath and still had the sock lines. They are major indentations. It only happens at night when she's at rest. She also had a low grade fever last night of 99.1. The sock lines really hurt, annoyingly and in both legs. Last night after it was more painful and this morning when she was retaining water she figured she would call and see if this was a normal side effect. Patient stated that she know soreness is a normal side effect but the fact she got sock lines and her legs were like balloons and she felt like she needed those things you get after surgery that they put on your legs and her legs are painful. Patient had a weird feeling. Patient was assured that HPV Vaccine the day before the Covid Vaccine would not interfere with Covid Vaccine. Patient stated that she took pictures of her sock lines on her legs and showed her friend who told her she should call Pfizer. She states the symptoms only seem to occur when her legs are at rest at night. Says they are sore the next morning, but that it goes away. Patient did not visited to Emergency Room/ Physician Office. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1673354
Sex: F
Age:
State: CA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210412; Test Name: Nasal Swab; Test Result: Negative ; Comments: nasal swab

Allergies:

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

Symptoms: 1st week flared up Peripheral Neuropathy; As soon as I received 2nd shot, felt sensation in feet (heavy, like asleep).; sensations in feet, lower legs - tingling, needles & pins, burning; sensations in feet, lower legs - tingling, needles & pins, burning; Sensations in new places, Arms, Upper Legs, and Face; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 25Feb2021 (at the age of 73-year-old) (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation, administered at Doctor's office/urgent care. Medical history included neuropathy peripheral, tinnitus, Raynaud's phenomenon. No COVID prior vaccination. Concomitant medication(s) included cefixime (FLEXERIL); famotidine (PEPCID); colecalciferol (VITAMIN D 3), all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin b and experienced hypersensitivity. The patient previously bnt162b2 on 02Feb2021 (Batch/Lot number EL3247) (at the age of 73-year-old) in left arm dose 1 for COVID-19 immunisation, administered at Doctor's office/urgent care. Patient was not pregnant. No other vaccine in four weeks. On 25Feb2021 the patient experienced 1st week flared up peripheral neuropathy (non-serious) with outcome of recovered with sequelae, as soon as she received 2nd shot, felt sensation in feet (heavy, like asleep) (non-serious) with outcome of recovered with sequelae. The course of events was as follows: As soon as she received 2nd shot, she felt sensation in feet (heavy, like asleep). 1st week flared up peripheral neuropathy. Sensations in feet, lower legs - tingling, needles & pins, burning. Sensations in new places, arms, upper legs, and face. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included: Sars-cov-2 test (nasal swab): negative tested post vaccination on 12Apr2021. No treatment received. The patient recovered with lasting effects.

Other Meds: FLEXERIL [CEFIXIME]; PEPCID [FAMOTIDINE]; VITAMIN D 3

Current Illness:

ID: 1673355
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 09/04/2021
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: arm (on the side of the injection down to her wrist) still hurts from it; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on an unspecified date in Jun2021 at the age of 58-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date in May2021 at the age of 58-years-old as dose 1, single for covid-19 immunisation. It was reported that she received first shot of pfizer covid vaccine in May2021 and 2nd shot in Jun2021. Stated that since receiving her second shot on an unspecified date in Jun2021, her arm (on the side of the injection down to her wrist) still hurts from it. when she wakes up she can hardly move it. Adds before receiving the vaccine, she had no issues with her arm. She asked, why would her arm still hurt? The reporter asked, why should she have to pay for costs associated with side effects of the vaccine. The case was reported as non-serious. The outcome of event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1673356
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: tested positive for covid virus; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: positive for covid virus; positive for covid virus; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program COVAX US support. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was positive for covid virus. The patient on an unknown date underwent sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown. The lot number for the vaccine was not provided and will be requested during follow up. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1673357
Sex: F
Age:
State: LA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 09/04/2021
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: About 6 days after vaccination, started having shortness of breath and irregular heartbeat, Diagnosis with mild myocarditis; Pregnancy at time of Vaccination:Yes/gestational period:25 weeks; This is a spontaneous report from a contactable Nurse (Patient). This Nurse reported information for mother (herself). This is a maternal report. A 33-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 10Aug2021 at the age of 33 years (Lot number and Expiry date was not reported) as dose 1, single for covid-19 immunization. Medical history included Polycystic ovary syndrome (PCOS) and Hashimoto's. The patient did not have covid prior and post vaccination. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. The patient experienced pregnancy at time of vaccination:yes/gestational period:25 weeks on 10Aug2021, about 6 days after vaccination (discrepantly reported), started having shortness of breath and irregular heartbeat and went to cardiologist and diagnosed with mild myocarditis on 18Aug2021. The mother was due to deliver on 19Nov2021. It was reported, the event myocarditis resulted in the Doctor or Other health care professional office/ clinic visit, Emergency room/department or urgent care. It was reported, beta blocker was received as treatment for the event. The outcome for the event was Not recovered/Not resolved. The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association and known drug safety profile a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported event of Myocarditis. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673358
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 08/21/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210821; Test Name: PCR test; Test Result: Positive

Allergies:

Symptom List: Pain in extremity

Symptoms: Patient developed COVID-19 symptoms and subsequently tested positive by PCR test.; Patient developed COVID-19 symptoms and subsequently tested positive by PCR test.; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an intramuscular route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. It was unknown, if patient received any vaccine in 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient medical history and concomitant medications were not reported. It was reported that patient developed covid-19 symptoms and subsequently tested positive by pcr test. on 21Aug2021. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 21Aug2021. It was unknown if patient received any treatment. The clinical outcome for the event was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1673359
Sex: M
Age:
State: IN

Vax Date: 08/10/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: fever; body aches; didn't feel well; felt that his ankles were on fire. It went up above his knees to his legs; flushing; runny nose; sore throat; really sick for the next 2 days; moved up to his calf area, still burning; burning really hard again, all the way up above his knees; felt that his ankles were on fire. It went up above his knees to his legs/moved up to his calf area, above his socks; 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, Batch/Lot number was not reported), via an unspecified route of administration on 10Aug2021 as dose 2, single for covid-19 immunization. The patient medical history included blood cholesterol abnormal (reported as cholesterol). Patient concomitant medications were not reported. Patient was really sick for the next 2 days after the first dose of vaccine, he had fever and body aches that were really bad. Reporter stated that ever since then, patient was not feeling well. Reporter state that this morning the patient got up and he went into work and he called his wife about 08: 20, he had been at work about an hour and he asked if she changed anything with the laundry as he felt the feeling he felt years ago from his Cholesterol meds that caused flushing. He felt like his ankles were on fire. Wife told him they haven't changed any laundry stuff, soaps or anything. He felt like somebody had poured gasoline on his ankles, he thought something was wrong with his socks. He called the caller about an hour later and said it had moved up to his calf area, above his socks, it was still burning but not near as bad. He then called about half an hour ago and he said it's burning really hard again and it's all the way up above his knees. He was not feeling good, had runny nose and sore throat. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673360
Sex: F
Age:
State: NY

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/04/2021
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: headache on her left side, it is sore to the touch; headache on her left side, it is sore to the touch; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FD8448) via an unspecified route of administration, administered in Arm Left on 19Aug2021 (at the age of 58 years old) as dose 1, single for COVID-19 immunisation. Medical history included heart beats real fast (she has palpitations but it has not been diagnosed. sometimes she will be thinking too hard and gets anxious, and her heart beats really fast). There were no concomitant medication. The patient previously took lipitor for blood cholesterol (the only medication she takes was cholesterol and its from Pfizer. She clarifies she was taking Lipitor. She explains about 2 weeks ago, she stopped taking it because her cholesterol was under control). Patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Adverse event following prior vaccinations was none (never had any reaction to any medication). The patient experienced headache on her left side, it is sore to the touch on 19Aug2021. Reported as, she took her first dose of the Pfizer COVID-19 vaccine on 19Aug2021 and has been having a headache on her left side, it was sore to the touch, like if someone were to hit him on the head with something. She mentions she scheduled an appointment with her doctor for the first of November. Patient confirms the headache began late in the evening on Thursday, 19Aug2021. She states sometimes there is a sharp pain, like zoop zoop. Most of the pain is on her left side, but sometimes she feels it in her forehead. Outcome of the events were not recovered.

Other Meds:

Current Illness:

ID: 1673361
Sex: F
Age:
State: FL

Vax Date: 07/30/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: lose consciousness or pass out; weakness in the legs and arms; woke up with severe pain in legs and arms; Dizziness/light headed; blurred vision; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FC3180), via an unspecified route of administration, administered in left arm on 30Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included blood pressure increased (few years ago her husband died suddenly from cardiac arrest and her blood pressure increased). The patient's concomitant medications were not reported. Caller stated she was calling about the Covid vaccine. She worked part time as a caregiver. This past Monday night she started feeling like she was going to lose consciousness or pass out. It started severely on Monday evening. She called her doctor, and she was going to call rescue and then she fell asleep, and it passed. The next day she did not seem to have it then last night it started again but not as severe. Treatment - She went to the doctor as soon as side effects began, within 48 hours after the vaccine. She was not expecting flu like symptoms and fatigue. She clarified she did not get flu like symptoms and fatigue. Weakness in the arms and pain - It was the first thing, and she went to the doctor for that. Attempted to clarify with caller if this was on the first report. Caller clarified that weakness in the arms and pain was on the first report. She woke up with severe pain and weakness in legs and arms. She got her vaccine on 30Jul2021. It started in the middle of the night on 02Aug2021. Weakness in the legs and arms - It has not gone away, and she still has some pain. Treatment ? She went to the primary care every week but both times she was too sick to go into the office. She goes back to doctor next week. This was her third visit at the doctors since having the vaccine with the side effects. If she gets up too quickly, stand up too quickly she gets dizziness, lightheaded and blurred vision. A few years ago, her husband died suddenly from cardiac arrest and her blood pressure increased and she had to go on medication then she was off of it. She had to go back on the blood pressure medication when she had first started feeling like she was going to lose consciousness after the vaccine. She did not want to get the vaccine she got it because she was a caregiver. She went to pharmacy. She was not taking the second dose due to the side effects of the first one. The outcome of the event dizziness/lightheaded and blurred vision was unknown; event weakness in the legs and arms was not resolved; event lose consciousness or pass out and severe pain in legs and arms were resolved on an unknown date in Aug2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673362
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: stroke; This is a spontaneous report form a non-contactable consumer (co-worker). A female patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after the shot, the patient had a stroke, assessed as medically significant. At the time of the report the event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1673363
Sex: U
Age:
State: NJ

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID; Test Result: Positive

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Fully vaccinated and tested positive for COVID; Fully vaccinated and tested positive for COVID/Congestion, headache, low grade fever for one day; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021, as single dose(Lot Number: EL3247) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021, as single dose (Lot Number: EL3247) for covid-19 immunisation. Medical history included RA(rheumatoid arthritis). Concomitant medications included abatacept (ORENCIA), methotrexate and folic acid taken for RA. The patient experienced fully vaccinated and tested positive for covid on an unspecified date in 2021. The patient had congestion, headache and low grade fever for one day. The outcome of all events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: ORENCIA; METHOTREXATE; FOLIC ACID

Current Illness:

ID: 1673364
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Breakthrough COVID case after 2 PFE vaccinations; Breakthrough COVID case after 2 PFE vaccinations; This is a spontaneous report from a contactable Consumer or other non-HCP reported for a patient. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Feb2021 as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced breakthrough covid case after 2 PFE vaccinations. Event took place after use of product. It was reported that the second dose was given around mid Feb2021. The patient outcome of the event was unknown at the time of this report. No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673365
Sex: F
Age:
State: IN

Vax Date: 05/01/2021
Onset Date: 08/18/2021
Rec V Date: 09/04/2021
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: Breakthrough bleeding 30 years after having last period; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in May2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced breakthrough bleeding 30 years after having last period on 18Aug2021. The patient reported that 3 months after receiving the first dose and 30 years after her last period, she had breakthrough bleeding and had to go to the gynecologist. The clinical outcome of breakthrough bleeding 30 years after having last period was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673366
Sex: U
Age:
State: OH

Vax Date: 06/19/2021
Onset Date: 08/06/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210623; Test Name: Blood panels; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210623; Test Name: X-ray of heart; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210623; Test Name: EKG; Result Unstructured Data: Test Result:Unknown result; Comments: yes, it seemed to reveal nothing unusual

Allergies:

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

Symptoms: My back is very tender it feels as if it has been bnuised; Continued breast pain; lump in my right breast. I have a history of lumps and bumps that came and go. Several of them have enlarged since taking the vaccines; My clothes hurt and the bottom of my feet hurt and so did my shoes and socks.; Tonight pain in my ribs/right side and back.; Tonight pain in my ribs/right side and back.; Neck pain back of head pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0196, Expiry date: unknown, at the age of 69-year-old), dose 2 via an unspecified route of administration, administered in Arm Left (Vaccination Facility Type: Pharmacy or Drug Store, Vaccine Administered at Military Facility: No) on 19Jun2021 17:00 as dose 2, single for covid-19 immunization. Medical history included ongoing migraine since childhood migraine IBS, muscle spasms from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, breast mass from an unknown date and unknown if ongoing (lump in my right breast). Patient had a history of lumps and bumps that came and go. Concomitant medications included zolpidem tartrate (AMBIEN) taken for migraine from 2020 and ongoing; cefixime (FLEXERIL [CEFIXIME]) taken for muscle spasms, migraine from 2004 and ongoing; ibuprofen (ADVIL [IBUPROFEN]) taken for pain from an unspecified start date and ongoing. The patient experienced neck pain back of head pain (medically significant) on 06Aug2021. AE required visit to the event neck pain: could not move head. No treatment received for neck pain. The patient experienced tonight pain in my ribs/right side and back on 20Aug2021. The patient experienced my back was very tender it feels as if it had been bnuised (tenderness), continued breast pain, lump in my right breast. Patient had a history of lumps and bumps that came and go, several of them have enlarged since taking the vaccines, my clothes hurt and the bottom of my feet hurt and so did my shoes and socks on an unspecified date. The patient underwent lab tests and procedures which included blood test, chest x-ray and electrocardiogram with unknown results on 23Jun2021 yes, it seemed to reveal nothing unusual. The clinical outcome of neck pain was not recovered and clinical outcome of all other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: AMBIEN; FLEXERIL [CEFIXIME]; ADVIL [IBUPROFEN]

Current Illness: Chronic migraine (since childhood migraine IBS)

ID: 1673367
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Blood sugar dropped; Result Unstructured Data: Test Result:Decreased; Comments: it was 187; Test Name: Blood sugar dropped; Result Unstructured Data: Test Result:decreased; Comments: it was 67.; Test Name: Blood sugar dropped; Result Unstructured Data: Test Result:decreased; Comments: it went down to 50; Test Name: Blood sugar dropped; Result Unstructured Data: Test Result:decreased; Comments: lowest it ever was was 70 before the vaccine.

Allergies:

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

Symptoms: she is diabetic and her blood sugar is dropping really low; her arm was a little sore; she feels really shaky; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 2021 as dose 1, single for COVID-19 immunisation; insulin degludec (TRESIBA Lot number was not reported) via an unspecified route of administration from an unspecified date to an unspecified date, at 80 Units for an unspecified indication. Medical history included diabetic from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG) twice daily taken for diabetes mellitus, start and stop date were not reported. On an unspecified date, the patient experienced that she was diabetic, and her blood sugar was dropping low, her arm was a little sore. She was supposed to get the 2nd dose Saturday and she can't get it for 3 weeks. She got the vaccination like 3 weeks ago and was supposed to go this past Saturday for the other one. Her granddaughter that lives with her had Covid and was only 10 years old. The only side effect she noticed from the vaccine she was diabetic, and her blood sugar was dropping low. She got up this morning and it was 187 and she went ahead and had a bowl of cereal for breakfast, and this had happened several times in the last 3 weeks. Stated that her blood sugar around 10:45-11:00 she notices she feels shaky all over and went to check and it was 67. Caller states this happened over the weekend and last week it went down to 50 and it's never been that low, states the lowest it ever was 70 before the vaccine. She called the pharmacy over the weekend and she said she not had anybody reporting that with blood sugars and queried if there are any studies with diabetics with it affecting blood sugar. She still takes her Humalog in the morning and at night she takes the Flex Pan Tresiba, takes 80 units of Tresiba at night and takes 60 units before breakfast, lunch and dinner of Humalog, blood sugar dropped so low that at lunch time she will not take the Humalog, that she just checked it and it was 67 and had eaten 2 packs of cheese and peanut butter crackers and had orange juice, yesterday it was 50 so she fast ate a spoon full of sugar and orange juice. She was still feeling a little shaky and was laying down since the cheese with peanut butter and the orange juice. She had to carry something in her purse if she leaves the house to eat or something to bring her sugar back up and was curious if this was happening to other people that are diabetic. She had the injection Saturday around 11am and by 6pm her arm was a little sore and the next day and that was it, she had no other symptoms or side effects. Her granddaughter went to school Monday, Tuesday and Wednesday night she had a fever and said she didn't feel good and that her head hurt bad and felt like she was going to throw up. States the paediatrician sent a prescription to the ER for her to have a Covid test and called her Friday and said she tested positive. She was eating well and lots of fluids and said she felt fine and was sleeping a lot, the 8-year-old sibling can't go back to school until 06Sep2021 and the one with Covid can go back 31Aug2021. States she still had a runny nose and sore throat. since she had been exposed to COVID, the pharmacist told her to come back another time for her second dose. Caller was wondering if it was 3 weeks between the two doses and if it was ok to receive the second dose outside of the 3 weeks and queried if there are any studies with diabetics with it affecting blood sugar. The patient underwent lab tests and procedures which included blood glucose dropped resulted as decreased on an unspecified date it was 187, on an unspecified date it was 67, on an unspecified date it went down to 50, on an unspecified date on lowest it ever was 70 before the vaccine. The clinical outcome of the events was not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: HUMALOG; TRESIBA

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am