VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1426857
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Was in the hospital due to her heart and they had to do a eko gram.; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. Patient was supposed to get her 2nd dose of the Covid vaccine on 20Apr2021 but was in the hospital due to her heart and they had to do a ekogram on an unspecified date. She wanted to know what to do and where to go to get her 2nd dose. On unknown date, the patient underwent lab tests and procedures which included ekogram: unknown. The outcome of the event was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1426858
Sex: M
Age:
State: CT

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Tightening in throat (like the beginning of throat closing due to allergy); Redness inside throat.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm as a single dose on 22Apr2021 at 09:15 (at the age of 59-year-old) for COVID-19 immunisation. The medical history included seasonal allergies, allergic to horses, cats and hay. The patient previously took cherries, peaches, nectarines, plums, kiwi, melon, cantaloupe, raw nuts and raw carrots (as reported). Concomitant medication included famotidine(PEPCID) for an unknown indication ,fexofenadine(ALLEGRA)for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 01Apr2021 at 09:00, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient has not tested positive for COVID-19 since vaccination. The patient experienced tightening in throat (like the beginning of throat closing due to allergy) and redness inside throat on 23Apr2021 at 01:00. The patient took antihistamine ALLEGRA as treatment for reported events. The clinical outcome of the events tightening in throat and redness inside throat were recovered in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ALLEGRA; Pepcid

Current Illness:

ID: 1426859
Sex: M
Age:
State: NY

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 06/25/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Fever; Cold; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 47 years old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 14:00, (at the age of 47 years old) as a single dose of COVID-19 immunisation. The patient had no medical history. Concomitant medications include TYNALOL from unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; unknown) (at the age of 47 years old), via an unspecified route of administration in the left arm on 07Apr2021 at 17:00, as a single dose of COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 at 19:00 the patient experienced fever, cold and dizziness. The clinical outcome of fever, cold and dizziness was not recovered. No follow-up attempts are possible needed ; information about lot number cannot be obtained.

Other Meds: TYLENOL

Current Illness:

ID: 1426860
Sex: M
Age:
State: PA

Vax Date: 03/25/2021
Onset Date: 04/25/2021
Rec V Date: 06/25/2021
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: Vertigo - positional; dizziness; nausea; his is a spontaneous report received from a contactable consumer, the patient. A 42-year-old-male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in left arm on 25Mar2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypertension. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN) 20mg daily. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in left arm on 02Mar2021(at the age of 42-year-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Apr2021, the patient experienced vertigo -positional, dizziness and nausea. The treatment received for the events included meclizine 25mg three times per day. The clinical outcome of the events vertigo positional, dizziness and nausea was not recovered at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: LISINOPRIL

Current Illness:

ID: 1426861
Sex: F
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 04/18/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in left arm on 01Apr2021 at 10:30 as 1st dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Apr2021 (3 weeks later), she experienced a large lymph node on the back of her ear. She went to the doctor and was diagnosed with an infection. But the doctor did not ask if she received the vaccine. She was put on Amoxicillin, and it went away with taking the medication. She then stated that on 22Apr2021, 3 days after being prescribed the Amoxicillin, she received her second dose (LOT ER8729, left arm injection) of the vaccine. She had no reaction until 27Apr2021, 3 days ago. She experienced a rash all over her body after second dose. The doctor told her it's a rash caused by the Amoxicillin. She said that she had never been allergic to Amoxicillin in her life, but knows that there was a possibility that you can develop a allergy. However, the patient's mother stated that it may be from the vaccine. Patient would like to verify if a rash is a side effect of the vaccine. Her mom had never seen a rash like it. Patient added hives go away with Benadryl, usually. They were weird dots on her body now and do not know if it is from the vaccine. Patient had never had hives before this. Patient asking is Pfizer vaccine a cause of this. Patient does not remember the exact date that the enlarged lymph node went away. Patient continued to take the Amoxicillin. The outcome of the event was recovered on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426862
Sex: F
Age:
State: CA

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 06/25/2021
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: trouble breathing; throat felt like it was closing; sternum hurt; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration (patient age at the time of vaccination was 33 year and patient was not pregnant at the time of vaccination), administered in arm right on 30Apr2021 at 14:30 as single dose for COVID-19 immunisation. The patient's medical history included down syndrome. Patient not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took penicillin and experienced allergy. Patient was not received any other vaccine prior four weeks of vaccination. Patient received other medications two weeks prior of vaccination. About 12 hours after the vaccine, on 30Apr2021 at 03:00, the patient began with trouble breathing, throat felt like it was closing, and sternum hurt. The patient visited to emergency room/department or urgent care for the events. Since vaccination patient not tested for COVID-19. Therapeutic measures were taken as a result of the events with oxygen, tyelnol and hydroxyzine. Pfizer have permission to contact your/the patient's healthcare provider about this report. The outcome of the events was reported as recovered on unspecified date in 2021. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1426864
Sex: F
Age:
State:

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; caller reported a mild allergic reaction she experienced mouth itching and her tongue swelling up "a little bit" after the second dose; itching in tongue; back of throat; Itching in mouth, tongue, roof of mouth, back of throat; tightness in throat; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: EW0162), via an unspecified route of administration on 17Apr2021 at the age of 53-year-old as single dose for covid-19 immunization. The patient medical history was reported as none. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from 17Apr2021 to 17Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number:: EN6199; Expiry Date: Jun2021 ), dose 1 via an unspecified route of administration, administered on 12Mar2021 as single dose for covid-19 immunization. On 17Apr2021 the reporter reported that she has a mild allergic reaction she experienced Itching in mouth, tongue, roof of mouth, back of throat, Tightness in throat and her tongue swelling up "a little bit" after the second dose. Reporter also stated that her headache has ran from cheeks to the back of her neck, lasted for about 5-6 days. Was worst in the mornings as she took migraine medication. The reporter stated that she took Benadryl and a dose of her Inhaler before her second dose of the vaccine and she said she was still having to use her inhaler and take antihistamine daily. As her doctor had recommended that when she got the second vaccine to take the Benadryl beforehand and she could tell that the inhaler and Benadryl helped her after this dose of the vaccine. She was started to feel the symptoms but says she could tell that the medications were helped to fight them. The patient did not visit to Emergency Room or Physician Office. The outcome of events was recovering as reported by reporter. Follow-up attempts are needed. Further information is expected.

Other Meds: BENADRYL

Current Illness:

ID: 1426865
Sex: F
Age:
State:

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Severe Pain; Headache; Fever; Chills; Blurred vision; Tingling in hands and feet; Shortness of breath; Fatigue; Sweating; Uncomfortable sleeping on left arm; Lack of appetite; Couldn't eat, couldn't drink; Couldn't eat, couldn't drink; Felt like there was inflammation in her stomach; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8435 and expiration date was not reported), via an unspecified route of administration in left arm on 28Apr2021 at 19:00 as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder (reported as 2 years ago she had an ultrasound and was told she had a minor autoimmune). The concomitant medications included unspecified birth control pills and multivitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8131), via an unspecified route of administration in right arm on 07Apr2021 as a single dose for COVID-19 immunisation and experience soreness at the injection site which lasted for about 2 days and she could not sleep on that side of her body. No additional vaccines administered on same date of the Pfizer vaccine. No prior vaccination (within 4 weeks). On 29Apr2021, the patient experienced severe pain, headache, fever, chills, blurred vision, tingling in hands and feet, shortness of breath, fatigue, sweating, uncomfortable sleeping on left arm, lack of appetite, couldn't eat, couldn't drink, felt like there was inflammation in her stomach. The consumer stated that "the symptoms started about 12 hours later of vaccination. She had severe pain, headache, fever, chills, blurred vision, tingling in her hands and feet, shortness of breath, lack of appetite, couldn't eat, couldn't drink, inflammation in her stomach, fatigue, and sweating. Stated most of the symptoms lasted about 5 hours. She did not go to the emergency room/ physician office; she had people around her keeping an eye on her. She took Naproxen, Ibuprofen, Aspirin, and Anti-histamines. She still had fatigue, feels uncomfortable sleeping on her left arm and sweating. The sweating was worse in the morning and kind of feels like when you have a flu or virus and wake up sweating." The patient underwent lab tests and procedures which included ultrasound: minor autoimmune on unspecified date (reported as 2 years ago). Therapeutic measures were taken as a result adverse events. Vaccination facility type: Warehouse event. The outcome of events fatigue, sweating and uncomfortable sleeping on left arm were not recovered whereas the outcome of all other events were recovered on 30Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426866
Sex: F
Age:
State:

Vax Date: 12/09/2020
Onset Date:
Rec V Date: 06/25/2021
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: Xeljanz and leflunomide is not working; fatigue; This is a spontaneous report from Pfizer sponsored progra. A contactable other healthcare professional and consumer (patient) reported that a 54-year-old female started to receive tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, 11mg), oral from 09Dec2020 to ongoing at 11mg, once daily for rheumatoid arthritis; BNT162B2 (Solution for injection), via unspecified route administration from 28Apr2021, single dose for COVID-19 immunization and leflunomide via unspecified route of administration from an unspecified date to ongoing at an unspecified dose and frequency for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. Patient reported "changing plan with MD because combination of Xeljanz and leflunomide is not working; patient will move to Remicade but will keep taking Xeljanz until Remicade is ready to go; rheumatoid arthritis symptoms are constantly moving from joint to joint; patient had her second dose of covid-19 vaccine on Wednesday, 28Apr2021, and has been experiencing fatigue yesterday and today." MD aware. The action taken in response to the events for tofacitinib citrate was dose not changed and leflunomide was unknown. The outcome of the events was unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426867
Sex: F
Age:
State: CA

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Skin rash; Pins and Needles feelings on skin; Burning feeling; Worse with warm temperatures and exercise; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old female patient received her unknown dose number of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8735) via an unspecified route of administration on the left arm on 22Apr2021 at 9:30 hours (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patients medical history included Afib (atrial fibrillation) and a bad lower back. The patient received unknown medication as concomitant within 2 weeks of vaccination. The past drug history of the patient included penicillin, sulfur drugs and contrast dyes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient was not tested positive for COVID-19. On 23Apr2021 the patient experienced Skin rash, Pins and Needles feelings on skin, burning feeling and worse with warm temperatures and exercise. The clinical outcome of the events skin rash, pins and needles, burning skin and pyrexia were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426868
Sex: M
Age:
State: NJ

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Horrible nightmares; Sweating; Sore arm for 3 days; Feeling of unreality; Headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 36 years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Ew0171), via an unspecified route of administration in the left arm on 26Apr2021 at 16:45 (at the age of 36-years-old), as a first single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Suboxone (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 27Apr2021 at 13:00, the patient experienced horrible nightmares, sweating, sore arm for 3 days, feeling of unreality, headaches, and chills. The clinical outcome of horrible nightmares, sweating, sore arm, feeling of unreality, headaches, and chills was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: SUBOXONE

Current Illness:

ID: 1426869
Sex: M
Age:
State: CA

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: chills; Low grade fever and next day fever of 101.5; feeling fatigue; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received second dose of BNT162b2 (COVID-19 MRNA VACCINE BIONTECH; Lot number: 0172) via an unspecified route of administration in the left arm on 24Apr2021 at 1700, as a single dose for COVID-19 immunisation. It was reported that patient had no medical history. Concomitant medication included flonase nasal steroid (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 25Apr2021, the patient experienced fatigue. On 26Apr2021, the patient had low grade fever and on 28Apr2021, the patient had fever of 101.5 and chills. On 29Apr2021, the patient started to experience fatigue and fever again. The clinical outcome of the events fatigue, fever and chills were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426870
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/25/2021
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: injection site soreness; night sweats; itchy, hive-like rash on both arms 48 hours after shot; very mild pain during urination for a couple weeks; moderate arm pain the day after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 14:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included flax seed oil (MANUFACTURER UNKNWON) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced injection site soreness and moderate arm pain the day after injection at 00:00, night sweats from second night and continued for 7 days, itchy hive-like rash on both arms 48 hours after shot (lasted for 2-3 days), no medical attention needed and urination pain for a couple weeks, all on an unknown date in Apr2021. The clinical outcome of vaccination site pain, itchy rash, night sweats, pain in arm and urination pain was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426871
Sex: F
Age:
State: NY

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 06/25/2021
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: Light pink, mildly itchy rash on left hand and right side of my neck/lower face area.; This is a spontaneous report received from a contactable patient. A 30-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EW0169) in left arm on 28Apr2021 at 18:15 (at the age of 30 years-old) as a single dose for COVID-19 immunisation. The patient's concomitant medications included TRI SPRINTEC and IC PERMETHRIN cream within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 09:00, the patient experienced light pink, mildly itchy rash on left hand and right side of neck/lower face area. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. On an unknown date, the patient underwent nasal swab test and the result was negative. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event light pink, mildly itchy rash on left hand and right side of neck/lower face area was not resolved. No follow-up attempts are needed. No further information is expected.

Other Meds: IC Permethrin; Trisprintec

Current Illness:

ID: 1426872
Sex: F
Age:
State: AZ

Vax Date: 04/21/2021
Onset Date: 04/25/2021
Rec V Date: 06/25/2021
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: Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0164) via an unspecified route of administration, administered in right arm on 21Apr2021 11:30 (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. Patient was not pregnant. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0150) administered in right arm on 31Mar2021 12:45 AM (at the age of 38-year-old) for COVID-19 immunization. The patient experienced shortness of breath on 25Apr2021. The event was reported as non-serious. Patient did not receive treatment for the event reported. Outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1426873
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: Major pain in arm; chills off and on; This is a spontaneous report received from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 04May2021 at 18:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 13:00, the patient experienced major pain in arm and chills off and on. The clinical outcome of the events major pain in arm and chills off and on was not recovered at the time of reporting. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1426874
Sex: F
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain in my shoulder; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 27Sep2021), via an unspecified route of administration on 14Apr2021 (at the age of 73-year-old) as 1st dose, single for covid-19 immunisation.The medical history included blood pressure medication. Concomitant medication included lisinopril taken for blood pressure medication and thyroid medication. On 16Apr2021 patient experienced pain in shoulder. Consumer stated that she took Lisinopril, and it said a blood pressure medication and the thyroid medication, the both low. She just wondering how long this condition is going to lasts and exactly why, she believe that the Nurse who gave me the shot, put the it high on the shoulder towards the back of her shoulder and so if I try to see the bandage and she looked back and can't see the bandage. The 3rd day after she received the shot, she started having pain in shoulder to the point when she had to use the medication in order to get rid of it. So, she wanted and she did, well She went to her family doctor last week. Doctor felt that it does not related to the vaccine and she gave her exercises to do. The Patient stated that her concern is, was this damage to a ligament or a nerve or something to the shoulder capsule and why she was having for this long a period of time. Reported No Seriousness. The patient received treatment Tylenol (500mg), using ice, a heating pad, using topical such as Bio-freeze and Salonpas. "Consumer stated, "Well, it's better over two weeks, since she got her shot. So, it's a matter of 2 weeks now. So, she guess yes. Persisting.". The outcome for the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: LISINOPRIL

Current Illness:

ID: 1426875
Sex: F
Age:
State: CA

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 06/25/2021
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: Sore arm; Piercing headaches; Everything was too heavy for left arm; as soon as she got the shot, within seconds she got the feeling when she eats something sour; Tingling feeling in the back of her jaw on the left hand side/Palm of hand tingling to tips of fingers/Her arm started tingling within 15; Entire left arm went numb/her arm was numb up to the elbow; This is a spontaneous report from contactable consumer reporting for herself. A 36-years-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH- mRNA COVID-19 VACCINE; Solution for injection; Lot Number ER8735; Expiration date was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 11:30 (At the age of 36-years-old) as single dose for COVID-19 immunisation (to not die from Covid). Medical history included none. She is only on birth control. She has no medical conditions that she knows of. Family medical history: the only major thing was diabetes. Patient concomitant medications included, ongoing Birth control since she was 20, so 16 years from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine and had no adverse reactions that she knew of. The only thing she was ever told was, she was allergic to Penicillin. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Patients Medical History was, none.It was reported that, as soon as the patient got the shot, within seconds she got the feeling when she eats something sour, patient had a tingling feeling in the back of her jaw on the left-hand side (the side she got the shot). As she was waiting her entire left arm went numb and the palm of her hand was tingling to the tips of her fingers on 30Apr2021. On 01May2021, patient experienced sore arm, piercing headaches and everything was too heavy for left arm. Patient was just calling to check and wanted to report her symptoms. Patient asked if it was okay to get the second dose of the Covid Vaccine. She did not have the Physician details information handy and stated that never seen her because of Covid. Her jaw started tingling within seconds. Throughout the day it would come and go. It was just on the left-hand side. She probably experienced it twice, maybe 3 times that day. Her arm went numb as she was sitting for 15 minutes and waiting. It was not right away like the sour thing. When she got up, they said she could go which is another story. Her arm was numb, and she had tingling in the palm of her hand throughout her fingers. By the end of the night her arm was numb up to the elbow. She did notice on Saturday when she got a sore arm that holding her phone on the left side and everything was too heavy. It was like her arm was extra relaxed. She could not hold her phone in her hand for too long. It was extra relaxed, and even driving she could not hold on for long. She did not notice it much the day before, but she for sure had it for the whole day on Saturday. Patient also had piercing headaches that comes and goes. Her palm started tingling within 15 minutes. They kept her there for like an hour. Patient still had it halfway through the day. Her arm was sore on Saturday morning, which actually went away by Sunday. Patient thought she was recovered completely. She had not noticed anything that would make her think it had not. Her headaches started probably Saturday night. They were off and on, the day before the time of this report. Patient had one the morning on the day of reporting this event when she was on the phone. They come for a second then just go away. Patient did not require visit to Emergency room or Physician office due to the events. Investigation assessment or relevant tests included none. Investigation Assessment: No. Clinical outcome of the events tingling feeling in the back of her jaw on the left-hand side, arm started tingling, palm of hand tingling to tips of fingers recovered on 30Apr2021; outcome of the event sore arm recovered on 02May2021, piercing headaches had not recovered and outcome of other events were unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Birth control (She has been on it since she was 20, so 16 years.)

ID: 1426876
Sex: U
Age:
State: GA

Vax Date: 04/29/2021
Onset Date: 05/01/2021
Rec V Date: 06/25/2021
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: Excruciating pain to hit my arm; I'm just not feeling good. I started feeling like my body is off; I started having issues with some breathing, my breathing is off, it's not fluent like it usually do; I don't have the energy like I have been; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 29Apr2021 as 1st dose, single for covid-19 immunisation. Medical history included allergies from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient Stated, I took the vaccine on Thursday, On 01May2021 I'm just not feeling good, I did good on Friday, but Saturday I started feeling like my body is off, and I started having issues with some breathing, my breathing is off, it's not fluent like it usually do, and the end I just don't feel good in my body in the end yesterday in my right arm that's where they gave me the shot I had this , On 02May2021 excruciating pain to hit my arm and I noticed it was not that head up to here , wasn't there anymore so I don't know what happen with that, but the pain was really bad in my arm yesterday, so I'm not feeling good, On unknown date 2021 I don't have the energy like I have been and like I said, my breathing is off and I had inhaler that I use every now and then for allergies but inhaler didn't help with this, when I used this twice yesterday, still I don't feel any better. When probed for the medication for allergies consumer stated that he was taking clover inhaler which was not clarified appropriately. When paraphrased, Consumer stated, No, I'm not feeling good, I haven't said good since Saturday, I got up this morning for walking and I was afraid to walk too far so I stayed in the neighbourhood and I stopped after hour in walking I usually, I am energetic when I got through but not this morning. Like my energy was not there. Reporter was informed that was needed for the documentation of the safety report. Patient stated, I known whether or not I need to go to the ER. Therapeutic measures were taken as a result as i started having issues with some breathing, my breathing is off, it's not fluent like it usually do. The outcome of the event excruciating pain to hit my arm was reported as unknown and while for others was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1426877
Sex: F
Age:
State: NY

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 06/25/2021
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: Itching and hives; Itching and hives; Muscle aches; Arm soreness; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, in left arm on 29Apr2021 14:30 as single for COVID-19 immunisation. Medical history included of chronic autoimmune hives likely exacerbated by COVID vaccine, limited occurrence of hives since stopping oral contraceptive in Nov2020 and recent urinary tract infection (UTI). No allergies reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: L3247) via intramuscular route of administration, administered in arm left on 08Apr2021 at 12:30 (at the age of 41-year-old) as single dose for COVID-19 immunization. Concomitant medications included within 2 weeks of vaccination ascorbic acid, calcium phosphate, lactobacillus, vaccinium macrocarpon (AZO CRANBERRY), menotrophin (MENOPUR), follitropin beta (FOLLISTIM), nitrofurantoin and MVI (MULTIVITAMINS) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Apr2021, patient experienced arm soreness, fatigue and muscle aches on 30Apr2021. On 02May2021 01:00 the patient experienced itching and hives present on trunk, gluteal region, arms, legs, and scalp 3 days after second vaccine dose. The patient received treatment for the events was Zyrtec. The outcome of the events itching, and hives was not recovered and for all other events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: AZO CRANBERRY; MENOPUR; FOLLISTIM; NITROFURANTOIN

Current Illness:

ID: 1426878
Sex: F
Age:
State: SC

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; She is still having weakness, coughing, and breathing issues; did get the second dose after hospitalization/so she got her second dose yesterday, 05May2021; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported for a 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8736, Expiration Date: Jul2021, NDC not known), via an unspecified route of administration on 05May2021 16:00 as 2ND DOSE, SINGLE (age at vaccination: 73 years) for covid-19 immunisation. The patient's medical history included breast cancer, ongoing thyroid disorder, ongoing lung issues, cough, headache, tiredness, sickness from 01Feb2021 (Tested positive for the Covid 19 virus on 03Feb2021. The caller's wife started having symptoms. She had a cough, headache, sinus issues and tiredness.), bronchitis (Gets bronchitis easy). The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021, Lot number: EL3246, 1ST DOSE for covid-19 immunisation and had feels like she has a lot of weight on her chest, sinus issues on 01Feb2021 and tested positive for the Covid 19 virus on 03Feb2021. On 05May2021, the patient did get the second dose after hospitalization. She is still having weakness, coughing, and breathing issues. The patient underwent lab test and procedures included COVID-19 virus test positive on 03Feb2021 and Chest X-ray on an unknown date had unknown result. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Lung disorder (Verbatim: lung issues); Thyroid disorder (Verbatim: thyroid)

ID: 1426879
Sex: F
Age:
State: NJ

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 06/25/2021
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: Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration, on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the patient had reaction. The patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1426880
Sex: F
Age:
State: FL

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 06/25/2021
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: a sore arm for a few days with both doses in the left arm; This is a spontaneous report from a contactable consumer (patient) or other non HCP via agency. A 93-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN6208, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Mar2021 14:00 (at the age of 93-years-old) as 1st dose, single for covid-19 immunisation. Medical history included ongoing high blood pressure, cardiac stent, ongoing non-hodgkin's lymphoma. concomitant medications caller takes medicine but does not think they are relevant to this report. She does take medicine for her blood pressure. The patient previously took flu vaccine and experienced sore arm. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EP7533; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 09Apr2021 14:00 (at the age of 93-years-old) as second dose, single for covid-19 immunisation. She reports she did have a sore arm with both of her Covid 19 vaccines. On 19Mar2021, the patient experienced a sore arm after first dose. On 09Apr2021 the patient experienced a sore arm after second dose. Sars-CoV-2 antibody test came back that she has no antibodies after receiving both Covid 19 vaccines and she may not be getting the benefit of the Covid 19 vaccine because of her Non-Hodgkin's Lymphoma. Patient thought everything was fine. On 26 APR 2021, she had appointment with her oncologist, she has non-Hodgkin lymphoma, more or less in remission not getting treatments for 4- 6 months, she goes for complete blood test and visit with him. On that blood test, he added a SARS COV-2, antibody, LQG spike semi, quantitative. Took a few days before she could call him back from results of the particular test, it turns out that no antibodies were found. Her PCP on vacation, spoke to her 10May2021, she told her you have no immunity. and said, if you want you can come in and get the Moderna shot, you can get it here. because her Oncologist, said to not take any more tests, until you see her 14Jun2021 and we will take another blood test. The patient has been staying out of Restaurants, really staying away from people, wearing a mask. She went to her oncologist for a regular visit and her doctor did a complete blood test including the Sars-Cov2 antibody test. She had her second Covid 19 vaccine on 09Apr2021 and her appointment with her oncologist was on 26Apr2021. She was concerned because the Sars-Cov-2 antibody test came back that she has no antibodies. Her blood work was sent. She called her primary care doctor, and that doctor reviewed her blood work and confirmed that she had no Covid 19 antibodies. She hope's she was wrong. She has no immunity even though she had both her Covid 19 vaccines. She called the CDC, and the CDC said the Sars-CoV-2 antibody test wasn't a responsible test and she shouldn't have even taken the antibody test. She called her primary care doctor, and her primary care doctor offered the Moderna Covid 19 vaccine to her or another Covid 19 antibody test. She was not going to mix the Covid 19 vaccines. and her oncologist told her not to get any more blood tests until her next follow up visit on 14Jun2021. She was not sure if she even wants to take another antibody test. She was very unsure of what to do next. Her primary care doctor also said she may not be getting the benefit of the Covid 19 vaccine because of her Non-Hodgkin's Lymphoma. She does have Non-Hodgkin's Lymphoma, it's in remission. She was not getting active treatments. She sees her oncologist every two months and gets blood taken. She asked the health department where and she was told she should only get her Covid 19 vaccines in a hospital setting. She finally found that was giving the Covid 19 vaccines, so she was happy to go and get her vaccine. When probing The sore arm only lasted about 2-3 days with both doses; it was not terrible. She was just conscious that her arm was sore. The patient underwent lab tests and procedures which included complete blood test: results unspecified on 26Apr2021, sars-cov-2 antibody test: negative on 26Apr2021. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Blood pressure high (Verbatim: high blood pressure); Non-Hodgkin's lymphoma (Verbatim: Non-Hodgkin's lymphoma)

ID: 1426881
Sex: F
Age:
State: IL

Vax Date: 05/08/2021
Onset Date: 05/08/2021
Rec V Date: 06/25/2021
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: half of her body she is feeling numb; Dizzy; cannot see well from the right side of her right eye; heart is beating faster; can barely talk; throat closing; Allergic reaction; her throat clogged; difficulty breathing; Face swell; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old female patient (reporter's sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 08May2021 12:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included paracetamol (TYLENOL) taken for stomach hurt from 07May2021 to an unspecified stop date. The reporter called on behalf of the patient, that the patient got the vaccine on Saturday, 08May2021 at 12:15, so right after the administration of the first dose, the patient had allergic reaction, her throat clogged, throat was getting closed, had difficulty breathing and then her face started to swell, and the patient was administered or took an anti-allergic medicine and was sent to emergency room and they said it was an allergic reaction. The patient was still feeling bad. The reporter provided the important safety information, and the reporter were also asking why the common side effects was not advised before the administration. The reporter and patient went to the emergency room and was there until 1:00 am on Sunday, 09May2021. The caller was never admitted as a patient into the hospital. On 09May2021, when the patient left the emergency room, patient started that she was feeling numb on half of her body, started feeling dizzy, couldn't see well from her right-side eye, her heart was beating faster, and she can barely talk. The patient being able to barely talk comes and goes. The patient received the treatment in the emergency room. Reporter stated, "It's for side effects for vaccine she had allergies to the vaccine." The outcome of the events was allergic reaction, her throat clogged, difficulty breathing, face swell, can barely talk, throat closing unknown. The outcome of the events was half of her body she is feeling numb, dizzy, cannot see well from the right side of her right eye, heart is beating faster was not resolved. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds: TYLENOL

Current Illness:

ID: 1426882
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 62-year-old) as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications included Singulair. The patient stated that she got the COVID-19 shot a couple weeks ago, had a 102.3 fever on an unspecified date. The patient stated she was concerned about shortness of breath that she experienced for 12 hours after. Wanted to know if she could do anything else besides her inhalers. Wanted to know if she could take an extra Singulair pill that has to do with the lungs, or she should take other drugs such as Pulmicort and Levalbuterol tartrate. Therapeutic measures were taken as a result of shortness of breath. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: SINGULAIR

Current Illness:

ID: 1426883
Sex: F
Age:
State: NC

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my throat started to feel constricted; hives/rash developed on the left side of my neck, and across my chest; This is a spontaneous report from a contactable consumer ((the patient, reported for self). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8736, Expiration date: UNKNOWN) via an unspecified route of administration, administered in Arm Left on 11May2021 17:15 (at the age of 28-year-old) as single for covid-19 immunisation. The patient Medical history included food allergy to Peanuts, soy, shellfish, fish, sesame, legumes, coconut, nuts, stone fruit; Drug allergy to penicillin; Anaphylaxis allergic reaction from an unspecified date an unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 17:15 within two minutes of getting the shot patient stated that her throat started to feel constricted, within five minutes of getting the shot "hives/rash developed on the left side of my neck, and across my chest." She stated that throat continued to get constricted. She had a history of Anaphylaxis allergic reactions to various food, so she had felt her throat tighten due to food before, but this was different. Patient had visited Doctor or other healthcare professional office/clinic. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken because of throat continued to feel tight as she took Benadryl on the ride to the (ER) Emergency room/department or urgent care. No epi was taken before arriving at the hospital. Patient received steroids and Antihistamines at the ER. The outcome of the events were unknown. Device Date : 12May2021 Information on Lot/Batch number was available. Additional information has been requested

Other Meds:

Current Illness:

ID: 1426884
Sex: F
Age:
State: TX

Vax Date: 03/04/2021
Onset Date: 03/26/2021
Rec V Date: 06/25/2021
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 developed shingles; muscle twitching; This is a spontaneous report from a contactable Pharmacist (patient herself). A 69-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6199) via an unspecified route of administration in left arm on 04Mar2021 08:30 as 2nd dose, single dose for COVID-19 immunization. Patient was 69-years-old and was not pregnant at the time of vaccination. Patient did not had COVID-19 prior to vaccination. Patient was not tested for COVID-19 post vaccination. Vaccination facility type was reported as Health Clinic/Administration facility. Patient did not receive any vaccines within 4 weeks. Patient medical history included diabetic arthritis, heart problems, fibromyalgia and known allergies to versed, hydrocodone. Concomitant medications included atorvastatin calcium, losartan, metformin, ASA, dexamethasone sodium phosphate (DEXALAB [DEXAMETHASONE SODIUM PHOSPHATE]), metoprolol succinate (TOPROL). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Pfizer 6199) via an unspecified route of administration on 04Mar2020 08:30 (as reported) as 1st dose single dose for COVID-19 immunization. On 26Mar2021, patient developed shingles and had muscle twitching. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Patient did not receive any treatments for the adverse events. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: ATORVASTATIN CALCIUM; LOSARTAN; METFORMIN; ASA; DEXALAB [DEXAMETHASONE SODIUM PHOSPHATE]; TOPROL

Current Illness:

ID: 1426885
Sex: F
Age:
State: NC

Vax Date: 04/20/2021
Onset Date: 04/01/2021
Rec V Date: 06/25/2021
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: Sleepy; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She felt the blood flow at a tremendous speed, from the waist down; It could be a circulation problem because of her varicose veins; It could be a circulation problem because of her varicose veins; she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thinks she was probably dehydrated; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 82-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. as per reported, She received the first dose on 20Apr2021, then went home and was very sleepy, she took a nap. When she woke up, she couldnt get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp," so she had to massage herself. She lived alone and when she got up, she felt the blood flow at a tremendous speed, from the waist down. After that she drank water and the feeling disappeared. She thought it could be a circulation problem because of her varicose veins, she takes aspirin. She thought her reaction the first time might have been vaccine-related, it was "horrifying, very strong," she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thought she was probably dehydrated, so she was a little afraid to receive the second dose. However, now "I feel very good". Outcome of event Blood flow sensation was recovered on an unspecified date in 2021 and for remaining events its was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1426886
Sex: F
Age:
State: NC

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 06/25/2021
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: The dizziness was incapacitating; Had 100.6 temp and body aches; Had 100.6 temp and body aches; Sore arm; Temporary shortness of breath; This is a spontaneous report from a contactable other hcp. A 60-years-old female patient received BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, (Lot Number: EL3248 expiry date was not reported) dose 1 via intramuscularly administered at Arm Right on 13Jan2021 11:30 as 1st Dose, Single for Covid-19 immunization.The patient's procedural history included tonsillectomy and adenoidectomy, total abdominal hysterectomy, salpingo-oopherectomy and cholesytectomy (01Jan2004). The patient's medical history included mononucleosis (from 01Jun2020 to 01Mar2021). The patient's concurrent conditions noted hypertension (from 01Jan2013) and hot flashes. The patient family history included hypertension for maternal grandmother.Concomitant medications included . The patient had reaction immediately after 1st vaccine and she felt short of breath that evening on 13Jan2021. The patient had a sore arm 14Jan2021 (the next day). On an unspecified date, the patient had dizziness which was incapacitating and could not drive and also had 100.6 temp and body aches. The patient unable to stand without passing out.The patient received Dramamine for dizziness and Nyquil for fever and body aches and temperature.The patient received Nyquil (doxylamine-DM-acetaminophen) and went to bed. The patient reported that she was okay. The outcome of all the events was resolved on an unspecified date in 2021. Causal relationship:Is there a reasonable possibility that the event is related to suspect product: Yes No follow-up attempts are possible. No further information is expected. Comments/narrative: Reaction immediately after 1st vaccine. Felt short of breath that evening, took Nyquil went to bed. Besides a sore arm the next day, I was okay. Approximately 12 hours after second vaccine, I was achy, dizzy and had temperature of 100.6. Did go to walk but by the afternoon, felt bad enough and went home. The next day, was still dizzy, achy and was vasovagal with standing.Stayed home from work. The 3rd day, I felt ok, went to work.

Other Meds: LOSARTAN POTASSIUM/HCTZ; EFFEXOR

Current Illness: Mononucleosis

ID: 1426887
Sex: F
Age:
State: MA

Vax Date: 04/03/2021
Onset Date: 04/05/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours per night; muscle in her arm tightens up so tight it wakes her; both arms hurt from her elbows to shoulders and it is terrible at night.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: ER8737, expiration date: 31Jul2021) via an unspecified route of administration administered in Arm Left on 03Apr2021 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included ongoing breast cancer diagnosed 2.5 years ago and still being followed for it, ongoing irritable bowel syndrome diagnosed 5-6 years ago and had muscle aches in her legs from cholesterol medicines in the past. Concomitant medications included acetylsalicylic acid (ASPRIN, strength: 81 mg) at 81 mg once daily, bumetanide (strength: 1 mg) at 1 mg tables, 2 tablets on Monday, Wednesday and Friday and one tablet the rest of the week, glucosamine, methylsulfonylmethane (GLUCOSAMINE & MSM) one in the morning and one at night, 2x/day), letrozole (strength: 2.5 mg) at 2.5 mg once daily, levothyroxine (strength: 25 mg) at 25 mg, alternate day, lisinopril (strength: 5 mg) at 5 mg one at night, loratadine (CLARITINE), lorazepam, omeprazole (strength: 20 mg) at 20 mg, alternate day, probiotics once daily, calcium (strength: 600 mg) at 600 mg twice daily, vitamin c (ASCORBIC ACID, strength: 500 mg) at 500 mg once daily, vitamin d3 (strength: 500 mg) at 500 mg once daily, simethicone (strength: 125 mg) at 125 mg once daily. It was reported that within 2 days after vaccination, on 05Apr2021, the patient right arm started hurting from elbow to shoulder along with left arm then started hurting also but doesn't recall at what point it started. Patient thought that pain was due to the vaccine since in her left arm was also in pain. Further patient described pain as excruciating at night, in the evenings or when lays down, and tolerable during the day. On an unspecified date, the patient specified about the spasms and arms that tightens up during the night, which keep her up. On an unspecified date, the patient added she barely sleeps 3-4 hours per night, despite the muscle relaxant she takes. Patient further explained she cannot lift her arms as high in the morning and provided the following example: she couldn't open her venetian blind or put her coat without help. She specified the pain eases up during the day and can't move her arms as it hurts, the pain on a scale of 1-10 was a 15. Reporter assessed the event as non-serious. On unspecified date the patient underwent lab tests and procedures which included left arm x-ray and left arm x-ray found to be negative. The outcome of the events both arms hurt from her elbows to shoulders and it is terrible at night was not recovered while the outcome of the rest of events was unknown. Follow up attempts needed. Further information is expected.

Other Meds: ASPRIN; BUMETANIDE; GLUCOSAMINE & MSM; LETROZOLE; LEVOTHYROXINE; LISINOPRIL; CLARITINE; LORAZEPAM; OMEPRAZOLE; PROBIOTICS; CALCIUM; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; SIMETHICONE

Current Illness: Breast cancer (Diagnosed 2.5 years ago and still being followed for it.); Irritable bowel syndrome (Diagnosed 5-6 years ago.)

ID: 1426888
Sex: M
Age:
State:

Vax Date: 05/10/2021
Onset Date: 05/01/2021
Rec V Date: 06/25/2021
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: Gout flared up; he had pain in his arm at the injection site; has a rash on the back of his arm and around his neck; This is a spontaneous report from a contactable consumer reporting for himself. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: first dose of EW0176 and expiry date not reported) via an unspecified route of administration, administered in Left arm on 10May2021 (at age of 56-years old) as SINGLE DOSE for covid-19 immunization. Medical history included hypertension (he was diagnosed with high blood pressure over 10 years ago), ongoing gout (he was diagnosed with gout 5-6 years ago), Acid reflux (diagnosed with acid reflux well over 10 years ago), sinusitis (Sinuses), blood cholesterol (Pravastatin has been maintaining his cholesterol levels). Concomitant medication(s) included mometasone furoate (NASONEX) taken for sinusitis he has been using it for about 10 years; lisinopril taken for hypertension, he has been taking Lisinopril for over 10 years now; pravastatin taken for blood cholesterol, he has been taking Pravastatin for 10 years now; omeprazole (PROTONIX) taken for gastrooesophageal reflux disease he has been taking Protonix for well over 10 years; and colchicine (COLCHICINE A) taken for gout, start and stop date were not reported. Caller reported that he had pain in his arm at the injection site the next day after the Covid-19 vaccine, 11May2021 and the pain at the site went away on day 2, 12May2021, or day 3, 13May2021. His gout flared up the night of Thursday, 13May2021. Caller reported that he took some medication for his gout flare up so it's going away. Also reported that, the gout flares up got better the afternoon of Saturday, 15May2021 when he took his gout medication. Caller reported that he has been taking his medication for gout, so he doesn't feel the gout flare up as much now as he did. On unknown date in May2021, he had a rash on the back of his arm and around his neck that wasn't there before he got the Covid-19 vaccine. Caller reported that the rash began a couple of days ago. Caller reported that he has been taking one pill of Colchicine daily for his gout flare up. Caller reported that he only takes the colchicine as needed and that he normally avoids the foods that cause his gout to flare up. Caller stated that he needed to leave the house. Caller unable to complete vaccine supplemental form with agent. Therapeutic measures were taken as a result of gout flared up: treatment included Colchicine. The outcome of the events pain in his arm at the injection site and gout flared up was resolved on unknown date in May2021. The outcome of the event rash on the back of his arm and around his neck was not resolved. Information on lot/batch number was available. Additional information has been requested.

Other Meds: NASONEX; LISINOPRIL; PRAVASTATIN; PROTONIX [OMEPRAZOLE]; COLCHICINE A

Current Illness: Gout (Verbatim: Gout he was diagnosed with gout 5-6 years ago.)

ID: 1426889
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; she has been experiencing on going cardiovascular, respiratory, cognitive, musculoskeletal, neurologic and integumentary side effects; This is a spontaneous report from a contactable consumer (Nurse-patient) via medical information team. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685), via an unspecified route of administration, administered in Deltoid Left on 22Dec2020 (at the age of 48-year-old), as 1st dose, single for covid-19 immunisation. Medical history included ongoing hyperlipidemia, ongoing vasomotor symptoms related to Menopause, ongoing allergic rhinitis and chronic allergy. Concomitant medications included Montelukast sodium (SINGULAIR) 10mg, once daily, Pravastatin sodium (PRAVACHOL) 20 mg once daily; Medroxyprogesterone acetate (PROVERA) 2.5 mg once daily and Estrogens conjugated (PREMARIN), all taken for an unspecified indication, start and stop date were not reported. Patient reported that Premarin cream, I think its I forget to measure that 0.5 was it grams. Vaginally, Its Premarin cream 0.5g vaginally and I think its 0.625. On 22Dec2020, within five minutes after vaccination, the patient experienced cardiovascular, respiratory, cognitive, musculoskeletal, neurologic, and integumentary side effects. The patient stated that she had for the first two months they worsened and then they have plateaued and were not improving. She had been out of work for three months. Investigation assessment was done. The patient lab tests included CBC, CMP, TSH, Sed Rate, CRP and then a Coronavirus Antibody test and the nucleocapsid antibody test, for all the tests the results were unknown. It was reported that everything was normal and there was no evidence of active antibodies produced from the COVID infection, which was what the nucleocapsid test showed. The CBC recommended that test to determine because she had symptoms consistent with long haulers, but she had no evidence of antibody from infection (Further clarification unknown). Reportedly, patient did not receive her second dose because she was experiencing ongoing side effects and stated that she will not. Patient asked if someone was going to check in with her periodically to see If symptoms are improving. Was Pfizer studying the people researching the people, that are having long term side effect.The patient stated that she did not take any treatment as there was no treatment to take, had not received medical care. She reported that she would not even get a doctor to see her at any of the tertiary care facility in her area. Patient wanted to report this just to make sure that Pfizer note that she experienced the side effect. It was reported that patient experienced cardiovascular, respiratory, Cognitive musculoskeletal, integumentary and neurologic side effect which were related to Pfizer-BioNTech COVID-19 Vaccine. Reporter seriousness was unspecified. The outcome of the events was unknown at the time of this report. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: SINGULAIR; PRAVACHOL; PROVERA; PREMARIN

Current Illness: Allergic rhinitis; Hyperlipidemia; Vasomotor menopausal symptoms

ID: 1426890
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: diarrhea; cramping; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received second dose of BNT162B2(COVID-19 VACCINE, Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as second dose, single for COVID-19 Immunization. Patient medical history was not reported. Concomitant medication included secukinumab (COSENTYX) used for unspecified indication from unknown date and unknown if ongoing. Patient stated that she had diarrhea and cramping for the last 4 days after second Covid vaccine on unspecified date. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds: COSENTYX

Current Illness:

ID: 1426891
Sex: F
Age:
State: FL

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 06/25/2021
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: Contact Dermatitis in left eye; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: ew0185), via an unspecified route of administration in her left arm on 23Apr2021 (at the age of 55-years) at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication includes spironolactone (MANUFACTURER UNKNOWN), sottopelle and progesterin (MANUFACTURER UNKNOWN), all for unknown indications. On 14May2021, at 12:00 (at the age of 56-years), the patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA COVID-19 VACCINE; Lot number: Unknown), via an unspecified route of administration in her left arm as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient received the most recent COVID-19 vaccine at pharmacy or drug Store. The patient was diagnosed with COVID-19 prior to vaccination on an unknown date. The patient was not tested for COVID-19 since the vaccination. On 24Apr2021, the patient experienced contact dermatitis in her left eye. The patient experienced contact dermatitis in left eye after both vaccines. The patient received an ointment for the event contact dermatitis in left eye. The clinical outcome of the event contact dermatitis in left eye was resolved on an unknown date. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: SPIRONOLACTONE; progesterin

Current Illness:

ID: 1426892
Sex: F
Age:
State: MN

Vax Date: 05/13/2021
Onset Date: 05/01/2021
Rec V Date: 06/25/2021
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: runny nose; sneezing; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 41-year-olf female received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EW0185) via unspecified route of administration on 13May2021 on 14:30 as single dose in left arm for COVID-19 immunization in Hospital. Medical history and concomitant medications were not reported. the patient previously took first dose of bnt162b2 (Lot Number: EW0169) on 22Apr2021 13:00 in left arm and experienced smell and taste it feels weird, I can't taste food, food taste like something different and smell you know feels something different. She felt like she was having an allergic reaction, clarified she wakes up with a runny nose and sneezing and has never had this before. The runny nose and sneezing started third or fourth day after the second dose of the vaccine, it was a little better. No treatment was received in response to the events. Outcome of the events was recovering. Follow up needed, further information has been requested.

Other Meds:

Current Illness:

ID: 1426893
Sex: F
Age:
State: OH

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had some symptoms on covid of flu dose #1; loss of smell; fatigue; all symptoms of covid returned; Nausea; vomiting; diarrhea; COVID-induced POTS, no suspected; Hypercholesterolemia; paralysis; All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell/increasing SOB; Headache; upper respiratory symptom; chest pain; tightness; leg swelling; dizziness; extremity shaking; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9261),via intramuscular on 05Feb2021 10:20 (at the age of 46 years old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included Shingles 2x in Mar2016 & again 2017 after vaccine ,ongoing Treatment include Lyrica via oral route from 2016 ,Mono-epstein barr from unspecified date in Feb2020 to unspecified date in Aug2020 and covid-19 on 29Oct2020.Concomitant medications include Ibuprofen 800mg 3x/day for EVLT From Oct2019 to Apr2021,Progesterone from unknown date ,unknown if ongoing .Historical vaccine include Flu 10/20 Shoot before Covid on unspecified date in Oct2020. It was stated that father contracted covid for first time Dx on 10Mar2021. All his four children contracted it felty from his sibling brother. All five of us those ongoing fatigue, some with severe S.B, ongoing loss of taste & smell. All had same symptoms of covid after dose one. One sibling is resistant to vaccine based upon our reactions to vaccine. On 05Feb2021 After the vaccination of first dose the patient experienced Headache, upper respiratory, then increasing SOB(medically Significant), chest pain, tightness, then leg swelling, then onset of new symptoms of dizziness, paralysis(disability/medically Significant) and extremity shaking. On 17Feb2021, the patient experienced nausea and vomiting. Very sudden onset symptoms to 15Feb2021 but had to go to ER as SOB, had a PE after vaccine, had nature of covid but had all resolved after 1st dose. Will continue, no SOB, very little figure, 98%-99%c resolved. After shoot on 15Feb2021, had sudden diarrhea/SOB ponanysis. After taking a at school on 15Feb2021, ER after sudden onset, held the POTS, covid-induced POTS, no suspected. MCAS at 8 AM, excreted (adblosus disease. Hypercholesterolemia). Also, led to know after secure. We Appetited many food since vaccine. Seriousness criteria important medical event include hospitalization/prolongation of hosp, persistent/significant disability/incapacity. AE required visit to emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 16Jun2020, sars-cov-2 test positive on 29Oct2020, computerised tomogram pe ruled out on 17Feb2021, electrocardiogram stroke ruled out on 19Feb2021 and magnetic resonance imaging stroke ruled out on 19Feb2021. Treatment was received for events. Outcome of the events All 5 of us have ongoing pathogen, some with severe SOB ongoing loss of taste and smell. and had some symptoms on covid of flu dose 1, loss of smell, diarrhea, covid-induced POTS, no suspected, hypercholesterolemia and all symptoms of covid returned was unknown. Outcome of the other events was recovering.

Other Meds: IBUPROFEN; PROGESTERONE

Current Illness:

ID: 1426894
Sex: M
Age:
State: MN

Vax Date: 05/18/2021
Onset Date: 05/21/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Redness; Heart palpitations; Chills; Fever; heart issue; Fatigue; This is a spontaneous report from a contactable consumer (patient) via COVAES. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8736) via an unspecified route of administration in the left arm on 18May2021 at 12:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included non-ST elevated myocardial infarction (NSTEMI), aortic valve replacement, dye contrast allergy, and 4 stents placed, all from unknown dates and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN), apixaban (ELIQUIS), lisinopril, and metoprolol, all from unknown dates for unknown indications. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccine in four weeks. The patient previously received ciprofloxacin, metformin, and simvastatin, all from unknown dates for unknown indications and experienced drug allergy. On 21May2021 at 12:00 the patient experienced redness, and heart palpitations. The patient stated he was having heart issues before vaccination which he stated could be verified by records. He also had chills, fever, and fatigue, but not severe, "only heart issue" stating he had been having heart issues but reaction to vaccine had not been severe. The events resulted in an emergency department visit; no treatment was received for the events. The clinical outcomes of redness, heart palpitations, chills, fever, fatigue, and heart issues were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; ELIQUIS; LISINOPRIL; METOPROLOL

Current Illness:

ID: 1426895
Sex: F
Age:
State:

Vax Date: 05/21/2021
Onset Date:
Rec V Date: 06/25/2021
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: Tired/fatigue; Headachy; a puffy corner on the side of her eye; toothache; This is a spontaneous report from a contactable consumer (patient). This 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 21May2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported she received the second dose of BNT162B2 on 21May2021 and she was still feeling tired and "headachy." She also had a puffy corner on the side of her eye and a toothache that developed right after the vaccine. The patient had a video appointment with her doctor, and they were unable to see the puffiness but gave the patient a referral. The patient reported she was now (as of 25May2021) experiencing headache and fatigue even a few days after the vaccine. She inquired if it was common to last this long, if she could call out of work, and if tooth pain was a reported side effect. The clinical outcomes of tired/fatigue, "headachy," puffy corner on the side of her eye, and toothache were not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1426896
Sex: F
Age:
State: MO

Vax Date: 05/23/2021
Onset Date: 05/24/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rib cage area is sore; pains throughout arm; redness and swelling at the injection site; redness and swelling at the injection site; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0173) via an unspecified route of administration on 23May2021 at 14:15 (at the age of 34-years-old as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and borderline diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included pantoprazole (PROTONIX); ethinyl estradiol, ferrous fumarate, norethisterone acetate (TAYTULLA); rosuvastatin; buproprion XL, and "noreth" from unknown dates for unknown indications. The patient previously received hydrocodone from an unknown date for an unknown indication and experienced allergy. On 24May2021 the patient experienced rib case area was sore, pains throughout arm, and redness and swelling at the injection site. The patient did not receive any treatment for the events. The outcomes of rib case area was sore, pains throughout arm, and redness and swelling at the injection site were unknown. It was also reported that since the vaccine the patient was not tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Other Meds: BUPROPION HCL XL; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ROSUVASTATIN; TAYTULLA

Current Illness:

ID: 1426897
Sex: U
Age:
State: FL

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 06/25/2021
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: weird numbing, tingling, burning, freezing sensations in my thighs; weird numbing, tingling, burning, freezing sensations in my thighs; weird numbing, tingling, burning, freezing sensations in my thighs; weird numbing, tingling, burning, freezing sensations in my thighs; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the first one, on an unspecified date in 2021 had weird numbing, tingling, burning, freezing sensations in my thighs. Reporter seriousness for all the events was unspecified. The outcome for all the events was not recovered. Additional Context: Consumer stated, "I had my first shot on like 30Mar and my second one on 20Apr and after the first one, I was getting these weird numbing, tingling, burning, freezing sensations in my thighs. I didn't think anything for a while and then after I had my second one, it got like a little worse and it is like my legs are (sentence incomplete) and it is every day and even right now, I am trying to scratch my thighs because they itch, they burn, they freeze and they are numb. I don't know if (sentence incomplete), I don't know what is going on. I lost my job in September and I don't have insurance anymore. So, I do not have a primary care physician and I didn't inject myself with the shot, I was told to have it. So, what do I do now?" Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1426898
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: During these holds the inflammation and stiffness came back; During these holds the inflammation and stiffness came back; This is a spontaneous report from a contactable other health professional and a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) as a single dose, 2nd dose via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the inflammation and stiffness came back during these holds on an unspecified date. The outcome of the events was unknown. Clinical course: patient reported after start of therapy she missed 7 days of medication for her first covid-19 vaccine at the end of April 2021and another 7 days for her second covid-19 vaccine two weeks ago. patient reported during these holds the inflammation and stiffness came back. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1426899
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date: 04/28/2021
Rec V Date: 06/25/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Coronary artery occlusion; get's weak easily/ weakness; dizziness; Heart attack; This is a solicited report from non-contactable consumer (patient) based on the information received by Pfizer. (Mfr. Control No.: 21K-163-3889347 -00). A 66-years-old female received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were unknown) via intramuscularly on 03Mar2021 (at age of 66-years-old) as a single dose for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen) via subcutaneous route at 40mg/ 0.4ml (daily dose: 1, Citrate free: 40 mg, 1 in 2 week) for moderate to severe chronic plaque, psoriasis, psoriatic arthritis, ongoing since Jan2019. Medical history included heart disease, high blood pressure, slightly elevated cholesterol level from 2005, supplement, cartilage disease, thyroid disease, anxiety, tobacco use, one pack of cigarettes (from 1966 to 2016), recurrent difficulty in sleeping since 1971, alcohol use from 1971, one glass of wine a glass of bourbon from 1972), recurrent joint pain from 2005 and rheumatoid arthritis. Concomitant medications included acetylsalicylic acid (ASPIRIN) and clopidogrel both for heart disease; metoprolol and lisinopril for high blood pressure; atorvastatin for cholesterol; clobetasol via topical route, methotrexate, ibuprofen and omeprazole for an unspecified indication; folic acid and colecalciferol (VITAMIN D3) both as supplement; glucosamine for cartilage disease; levothyroxine for thyroid disease and naproxen for anxiety. Patient had previously received first dose of vaccine (lot number and expiration date were unknown) via intramuscularly on 17Feb2021, and on same day experienced light headed/ dizziness and recovered on 19Feb2021. On 28Apr2021, patient had heart attack and get's weak easily/ weakness. On 29Apr2021, patient had Coronary artery occlusion. On 28Apr2021, the patient was hospitalized for three days due to heart attack. On 29Apr2021 angioplasty procedure was performed and stent was laced that her artery was 99 percent blocked. She also stated that her heart muscle did not show any damage. She was monitored her electrocardiogram after the procedure and was given blood thinners, blood pressure medication and medication for cholesterol. She was scheduled for a follow up with her cardiologist on 26May2021. She was also advised do cardiac rehabilitation for 12 weeks. The alternate etiology as per the reporter for the event slightly elevated cholesterol level was weight. The alternate etiology as per the reporter for the event light headed and dizziness was COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Blood cholesterol test was performed in Apr2021 and result was 130. The reporter's causality for the events of cardiac artery blocked and get's weak easily was not provided. The reporter's causality for the event(s) of heart attack and light headed/dizziness with adalimumab (HUMIRA) 40mg/0.4ml was no reasonable possibility. The opinion was that there was no reasonable possibility that the events of cardiac artery blocked, heart attack, get's weak easily and light headed/dizziness are related to adalimumab (HUMIRA) 40mg/0.4ml. The action taken in response to the events for adalimumab (HUMIRA) was unknown. The outcome for event weakness was resolving and for light headed/ dizziness was resolved on 19Feb2021, coronary artery occlusion and heart attack was resolved on 30Apr2021. Causality for Covid-19 Vaccine For Coronary artery occlusion Causality as per reporter (Drug/Vaccine): Not assessable For heart attack Causality as per reporter (Drug/Vaccine): Not Related For weakness Causality as per reporter (Drug/Vaccine): Not Related For dizziness Causality as per reporter (Drug/Vaccine): Probable No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; CLOPIDOGREL; METOPROLOL; LISINOPRIL; ATORVASTATIN; CLOBETASOL; FOLIC ACID; GLUCOSAMINE; IBUPROFEN; LEVOTHYROXINE; METHOTREXATE; OMEPRAZOLE; NAPROXEN; VITAMIN D3; HUMIRA

Current Illness: Sleep difficult (recurrent difficulty in sleeping)

ID: 1426900
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: felt like was going to pass out; became very cold; she didnt eat today; This is a spontaneous report from a contactable consume reported for a female friend from a mass vaccination event. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date, as unknown single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient felt like she was going to pass out and became very cold on an unspecified date, after the vaccination at a mass vaccination event. She had to lay down after 10 minutes and EMTs were called and was not sure of result or any other information except she did not eat for the day. The outcome of the events was unknown at the time of this report. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1426901
Sex: F
Age:
State: NY

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 06/25/2021
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: Burning up and severe chills: States these were like she never had before. Used four blankets and bed pillows trying to warm up; she felt so hot/ she figured it was about 104/ burning up/ Temperature around 100 and 101; she is exhausted; Pains in toes and finger joints; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EP7534), via an unspecified route of administration, administered in arm left on 30Mar2021 12:30 PM (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient medical history included inflammatory eye problem (patient had this 10 year. Does not think this is anything related), ileostomy for 50 years. The patient took no concomitant medications. No family medical history. The patient did not receive any other vaccines prior vaccinations within 4 weeks. No additional vaccines administered on same date. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: ED6203), via an unspecified route of administration on 09Mar2021 (at the age of 64-year-old) for COVID-19 immunization and experienced pain in extremity, injection site mass, injection site swelling, injection site erythema, rash. Patient stated she was reporting side effects again. Stated that she reported after the first dose, where she had problems with her arm, reported having a big lump and rash. Patient stated that she got the shot on Tuesday, was fine all afternoon and evening. On an unspecified date in 2021 during the night she felt so hot, wouldn't even take her temp because she figured it was about 104. Burning up and severe chills: Stated these were like she never had before. Used four blankets and bed pillows trying to warm up. Temperature around 100 and 101: Stated that this started the next day, which was yesterday that it has been staying between 100 and 101. Stated she was exhausted. Pains in toes and finger joints: Stated that this was going on now and has no muscle soreness or aching. The patient received Motrin as a treatment. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1426902
Sex: F
Age:
State: IL

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 06/25/2021
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: Gum Periodontitis; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received 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 19Feb2021 as a single dose for covid-19 immunization. Medical history included ache in upper left gum (molar area) from 20Jan2021, patient had Teeth Periodontitis on 20Jan2021 (Admission to the hospital due to the event: No, Any treatment received: Yes, Still experiencing: Fine Now). The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 29Jan2021for COVID-19 immunization and fistula was developed on her gum on 06Feb2021. The patient received the second dose of vaccine on 19Feb2021 and on the same day she experienced gum periodontitis. She waited until 05Mar2021 for procedure to clean around and under her tooth. Her next appointment was on 29Mar2021 and it appeared better. Treatment medication included antibiotic for 5 days. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1426903
Sex: M
Age:
State: OH

Vax Date: 03/31/2021
Onset Date: 04/27/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: complete hearing loss in right ear; 10 fold increase in tinnitus; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in left arm on 31Mar2021 13:30 (batch/lot number ER8733 and expiry date unknown) at 66 years of age as dose 1, single for covid-19 immunization received in a hospital. Medical history included ocular MG (migraine), benign prostate enlargement, hiatal hernia, high cholesterol, ongoing tinnitus. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no covid prior vaccination. Concomitant medications included omeprazole, simvastatin, finasteride; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he experienced 10 fold increase in tinnitus, complete hearing loss in right ear (medically significant). The patient informed that the adverse events start date was 27Apr2021 and start time 09:45 am. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient was not covid tested post vaccination. The patient received steroids due to the events. The outcome of the events was not recovered.

Other Meds: OMEPRAZOLE; SIMVASTATIN; FINASTERIDE

Current Illness: Tinnitus

ID: 1426904
Sex: F
Age:
State: CA

Vax Date: 05/01/2021
Onset Date: 06/01/2021
Rec V Date: 06/25/2021
Hospital: Y

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: Large burden of DVT/PEs; Large burden of DVT/PEs; Associated acute kidney injury and fevers; Associated acute kidney injury and fevers; This is a spontaneous report from a contactable physician. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included drospirenone, ethinylestradiol (YASMIN) taken as birth control pills, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. The patient diagnosed with COVID-19 prior to vaccination. The patient experienced large burden of DVT/PEs noticed approximately 1 month after vaccination in Jun2021 and associated acute kidney injury and fevers. Events resulted in visit to Doctor or other healthcare professional office/clinic and Emergency room/department or urgent care. Patient was hospitalized for the events. Treatment received included anticoagulation + IVC Filter. Outcome of the events was recovering. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events cannot be excluded. The impacts of this report on the benefit/risk profile of the product and on the conduct of the study are evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: YASMIN

Current Illness:

ID: 1426905
Sex: F
Age:
State: NC

Vax Date: 05/22/2021
Onset Date: 05/01/2021
Rec V Date: 06/25/2021
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: having some mild heart pain that fades away; had a mild heart pain and moderate pain in the chest; wife also had blood in he mouth. She was coughing up blood; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22May2021 (lot number and expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of the Pfizer COVID-19 vaccine. On 23May2021 (second day), she had a mild heart pain and moderate pain in the chest for 1-2 days. The adverse events already decreased and faded away. On unspecified date in May2021, the patient also had blood in the mouth. She was coughing up blood. It was a one-time event. The husband reported that his wife (patient) wanted to know if she would have these adverse events with the second dose of the vaccine. Outcome of the events was recovered on unspecified date in May2021. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1426906
Sex: F
Age:
State: OH

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: blackouts; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; Bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movemen; pressure in bowel movements,; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 59-years-old via an unspecified route of administration, administered in Arm Right on 28May2021 16:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced bad rash all over body, itching, fast heartbeat, dizziness, constant headache, feeling tired all the time, cramping in stomach constantly, burning sensation in right foot and pressure in bowel movements, having blackouts on 28May2021 16:00. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit. Treatment was received including Horticozone Shot. The outcome was recovering. Seriousness was reported as yes. Information on the Lot / Batch number has been requested.

Other Meds:

Current Illness:

ID: 1426907
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: Extremely high fever that led to a seizure; Extremely high fever that led to a seizure; This is a spontaneous report from a contactable consumer (patient's parent) received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES) portal. A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Jun2021 at the age of 12 years old (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at the age of 12 years old, dose 1 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jun2021 at 20:00, the patient experienced extremely high fever that led to a seizure. The adverse event did result in an emergency room/department or urgent care. Therapeutic measures were taken as a result of extremely high fever that led to a seizure, which included emergency medical services (EMS) support, paracetamol (TYLENOL), and ice bath. The patient recovered from the events on an unspecified date. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm