VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1320331
Sex: F
Age:
State: LA

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: 3rd time CMV has reactivated; This is a spontaneous report from a contactable consumer (patient) reported that a 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration, administered in arm left on 05Apr2021 14:45 (02:45 PM) (at the age of 36-years-old) as 1st dose, single for covid-19 immunization. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient medical history included that she had preeclampsia, HELLP syndrome and CMV when she delivered her son 3 weeks early on 28Jan2021. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ferrous sulfate; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) both taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, for the 3rd time CMV has reactivated. It was unknown if the patient received treatment for the event. The outcome of the event was unknown. She also added that she also have a colicky 3-month-old at home that her husband dealt with.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509886 baby case

Other Meds: FERROUS SULFATE; ADDERALL

Current Illness:

ID: 1320332
Sex: F
Age:
State: NY

Vax Date: 04/15/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
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: however she tested positive with her Strep test yesterday (03May2021) and she also started to take Azithromycin yesterday.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (mother) reported for a 16-year-old female patient reported that patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Batch/Lot number and expiration date were not reported), via unspecified route on 15Apr2021 at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient was scheduled to get the 2nd dose of the vaccine on 06May2021, however she tested positive with her Strep test yesterday (03May2021) and she also started to took Azithromycin yesterday. (name) wanted to know if her daughter could still take the 2nd dose on the scheduled date. The outcome of the events was unknown Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320333
Sex: M
Age:
State: KY

Vax Date: 04/08/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
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: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, in arm left, on 08Apr2021 16:00 (at the age of 36-year-old), at single dose, for COVID-19 immunization. Medical history included cholesterol, anxiety, depression, and Barrera esophagus. No known allergies. Concomitant medications included unspecified medication (patient received other medications within 2 weeks of vaccination). The patient previously received 1st dose of BNT162B2 for Covid-19 immunization, in left arm. The patient experienced Bell's palsy a month after 2nd shot on 03May2021, and received Steroids and antivirus medicine as treatment. The event caused Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior vaccination. On 04May2021, patient had negative Covid test post vaccination with Nasal swab. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320334
Sex: F
Age:
State: WY

Vax Date: 04/01/2021
Onset Date: 04/09/2021
Rec V Date: 05/15/2021
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: Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021 Information about Lot/batch number was available. Further information was expected.

Other Meds:

Current Illness:

ID: 1320335
Sex: M
Age:
State: WI

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 05/15/2021
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: Pneumonia; headaches; fever; fatigue; chills; This is a spontaneous report from a contactable consumer (reporting for himself). A 75-years-old male patient received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced headache, fever, fatigue and chills. On 20Feb2021, the patient experienced pneumonia. The patient was recommended to get the Bamlanivimab infusion, which the patient did. The patient was told to wait 90 days after the infusion before getting his second dose of the series. The patient stated his 90 days will be up in about a week or so. The outcome of the event headache was recovered on 17Feb2021; fever and chills was recovered on 18Feb2021; fatigue was recovered on 20Feb2021; and pneumonia was recovered on 10Mar2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320336
Sex: F
Age:
State: WA

Vax Date: 04/15/2021
Onset Date: 04/26/2021
Rec V Date: 05/15/2021
Hospital: Y

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: multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pressure; decreased oxygen saturation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 at 10:30 (at age of 47 years old, no pregnant, Lot Number: EW0151) as a single dose for covid-19 immunization. Medical history included hypertension, known allergies Amoxicillin, sulfa, Keflex. Concomitant medications included losartan and omeprazole. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Apr2021 at 09:00, reported at 11 days post vaccine experienced shortness of breath, elevated heart rate, elevated blood pressure, decreased oxygen saturation. Diagnosed with multiple bilateral pulmonary embolism. No typical risk factors. Awaiting results of tests for protein s deficiency/factor 5/lupus. No family history of any. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care/ Life Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized from 26Apr2021 to 29Apr2021. The treatment received with IV heparin, now oral warfarin and Lovenox shots. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 test): negative on 28Apr2021, negative on 30Apr2021 and pending result on 02May2021. The outcome of the events was not recovered.

Other Meds: LOSARTAN; OMEPRAZOLE

Current Illness:

ID: 1320337
Sex: F
Age:
State:

Vax Date: 01/04/2021
Onset Date: 01/18/2021
Rec V Date: 05/15/2021
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: 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; This is a spontaneous report from a contactable pharmacist via medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Jan2021 (at the age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Jan2021-positive. It was reported as the patient received her first Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. She then received a "plasma transfusion on 28Jan2021. She is now returning for her second vaccine dose today 06May2021. The reporter asked if is this ok since it has been 90 days and does her first dose need to be repeated. Therapeutic measures were taken as a result of the event covid-19. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320338
Sex: M
Age:
State: TX

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 05/15/2021
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 cough and congestion and hacking up green stuff like infection; Severe cough and congestion and hacking up green stuff like infection; Pain in mouth; wheezing; Pain in face from that; in the roof of his mouth near his teeth and it was extremely painful; Excessive sleepiness; Pain in sinus cavity; Headache; Thrush; Cannot hardly breathe; Mouth blister; Laryngitis; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of bnt162b2 (BNT162B2), intramuscular, administered in Arm Right on 22Apr2021 (Batch/Lot Number: EW0151; Expiration Date: 01Jul2021) as 1st dose single for COVID-19 immunization, prophylaxis. Medical history included diabetes mellitus and blood pressure measurement ongoing. The patient's concomitant medications were not reported. Today is the first day he has a voice since the injection on 23Apr2021. He later stated he received injection on 22Apr2021. Today he is able to speak. The patient experienced laryngitis on 23Apr2021, excessive sleepiness (sleeping until around 3pm every day for the last 3 days) and pain in sinus cavity on 03May2021, cannot hardly breathe on 24Apr2021, mouth blister on 23Apr2021, thrush on 26Apr2021, headache on 27Apr2021, severe cough and congestion and hacking up green stuff like infection (cough and nasal congestion). He is getting a little better and is on antibiotics and Mucinex and everything trying to get a control of it. It has been so bad he cannot breathe. He is still wheezing. Now it is like bronchitis and he is still coughing today. In the beginning, it was like pneumonia. It was so bad. Pain in mouth, pain in face from that and in the roof of his mouth near his teeth and it was extremely painful on an unspecified date. He did not realize they were there until he brushed teeth and popped them and had massive amounts of blood in his mouth. He did not experience anything like that before and that really scared him. They gave Nystatin to heal up his mouth. Blisters are fading and blood blisters have stopped bleeding. He still has pain in mouth and face from that. He was also given Albuterol to help him breathe. The antibiotic is a great big pink tablet. It is 800 some mg of Amoxicillin. All of these are in a pharmacy vial and he does not have a lot or expiration for any. He was also prescribed Bromphen cough syrup. It is in a pharmacy vial with no lot or expiration. All are in pharmacy vials except the Mucinex and it is over the counter. He started taking it after the vaccine to control the cough. No further details provided. He was going to see an infectious disease doctor. They were going to do a vaccine challenge test to find out if he needs IVIG. He will see if it is something inside of him that the vaccine triggered that he needs to fix and won't know until he sees the doctors. The doctor's are hoping the infectious disease doctor will be able to give him answer about second dose as well. Received call from consumer regarding the Pfizer COVID vaccine. He received it at pharmacy and nothing happened the day of. He wanted to report what happened after that. He also would like to know if he should attempt to get second dose. PSCC Communicated to the patient as due to extended hold time caller opted to be transferred to hold his place in the queue and Provided caller with websites and contact information. Treatment was received and Therapeutic measures were taken. The outcome of the events pain in mouth, wheezing, pain in face and gingival pain were unknown whereas the other events were recovering. Follow up attempts needed. Further information is expected.

Other Meds:

Current Illness: Blood pressure; Diabetes

ID: 1320339
Sex: F
Age:
State: TN

Vax Date: 04/04/2021
Onset Date: 05/04/2021
Rec V Date: 05/15/2021
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: Bell's Palsy; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in left arm at the age of 34-year-old on 04Apr2021 15:00 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization. Medical history included asthma, pernicious anaemia, Polycystic ovarian syndrome, Hashimots thyroiditis, Atopic dermatitis. The patient's concomitant medications were not reported. The patient previous took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 07Mar2021 15:00 at left arm for COVID-19 Immunization. The most recent COVID-19 vaccine was administered at Hospital. No other vaccines within 4 weeks prior to the COVID vaccine received by patient, other medications the patient received within 2 weeks of vaccination confirmed yes but not specified and stated more than there was room for here. The patient experienced bell's palsy on 04May2021 12:00. The event resulted in Emergency room/department or urgent and Doctor or other healthcare professional office/clinic visit, no treatment received. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering. No follow-up attempts are possible. Information about batch/lot number can not be requested.

Other Meds:

Current Illness:

ID: 1320340
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 05/05/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Strong pain; Burning in legs, arms and different part of the body; Pins and needles in different parts and electric shock sensation; Pins and needles in different parts and electric shock sensation; Neck lymph nodes inflammation; Body temperature swings from cold to hot and the other way around; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 58-year-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0171 expiry date: unknown) dose 2 via an unspecified route of administration in left arm on 29Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. The patient did not have any medical history. She had known allergies: hives with yellow fever vaccine 7 years prior to this re-port. Concomitant medication in two weeks included EMERGEN-C (MINERALS NOS, QUERCETIN, THIOCTIC ACID, VITAMINS NOS). The patient received first dose of BNT162B2 (solution for injection, lot number: EW0151 expiry date: unknown) via an unspecified route of administration in left arm on 08Apr2021 01:15 PM (at the age of 58-years-old), as single for Covid-19 immunization. She did not receive any other vaccine same date of suspect product or within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 05May2021 09:00 AM, She experienced extremely strong pain and burning in legs, arms and different part of the body, pins and needles in different parts and electric shock sensation, neck lymph nodes inflammation, body temperature swings from cold to hot and the other way around. This was the second day, and she did not have relief yet. It was stated that Tylenol 500mg and Ibuprofen 200mg did not relief absolutely anything. On an unknown date, the patient was hospitalized. The patient did not receive any treatment for other events. The patient underwent lab tests and procedures included Body temperature: swings from cold to hot on 05May2021. The outcome of all events was not recovered.

Other Meds: EMERGEN-C

Current Illness:

ID: 1320341
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: I am bleeding heavily because I am getting blood clots and stuff like that; I am bleeding heavily because I am getting blood clots and stuff like that; Lot of pain in my joints and in my bones; Lot of pain in my joints and in my bones; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; Right side of face, my tongue inside is very swollen and irritated; This is a spontaneous report from two contactable consumers (one was the patient). A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FN6200), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation; axitinib (INLYTA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) at 2 pills once a day for clear cell renal cancer; pembrolizumab (KEYTRUDA), route of administration, start and stop date, batch/lot number and dose were not reported for clear cell renal cancer; zoledronic acid (ZOMETA), route of administration, start and stop date, batch/lot number and dose were not reported for the bones. The patient received the first dose of BNT162B2 on unknown date (Lot Number: CL9265) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was getting terrible side effects from either the axitinib or the pembrolizumab. The patient was bleeding very heavily and the right side of face and tongue inside was very swollen and irritated. The patient was getting a lot of pain in the joints and bones. The patient was bleeding heavily because was getting blood clots and "stuff like that" (as reported). The actions taken with axitinib, pzoledronic acid, and embolizumab were unknown." The outcome of the events was unknown. Follow up (23Apr2021): New information received from a contactable consumer includes reporter details. No Follow-up attempts are needed. No further information is expected. Follow-up (07May2021): This is a follow-up report to notify that the case 2021406450 and case 2021513212 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number 2021513212.

Other Meds:

Current Illness:

ID: 1320342
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: inflammation such as costochondritis and arthritis; numb behind her ear, her shoulder, her arm, and the back of her shoulder blade; the pain was unbearable; stiffness on the left side back of my ear down my neck, shoulder and down arm and back of that blade; Scapular pain; feeling of being warm then cold; arthritis; Costochondritis; it swells under the breastbone: severe pain After the vaccine right next to the sternum, below the neck that bone; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6207, Expiry Date: 31Jul2021), via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiry Date: 30Jun2021), via an unspecified route of administration on an unknown date for covid-19 immunisation. She received her 2nd vaccine she had stiffness on the left side back of my ear down my neck, shoulder and down arm and back of that blade. Scapular pain. (back of shoulder) she applied ice and warm compresses and few days subsided but not totally, had the feeling of being warm then cold and suffered with arthritis and inflammation of costochondritis (in the upper rib area). Initially it was the trapezius muscles (neck and shoulder) that swelled up. Inflammation had swelled up, shoulder blade, everything. It attacked her inflammatory and had a lot of pain. Costochondritis, when it begins it swells under the breastbone, severe pain. After the vaccine right next to the sternum, below the neck that bone never felt like that before, patient stated to the doctor, they told me to go to the ER because they weren't sure it wasn't a heart attack. They did a lot of tests and said it's inflammation. They had to give her anti-inflammatory and pain killers and was hospitalized. It's quieted down now because of pain killers and muscle relaxants On an unspecified date, The patient experienced inflammation such as costochondritis and arthritis with outcome of unknown, numb behind her ear, her shoulder, her arm, and the back of her shoulder blade with outcome of unknown , the pain was unbearable with outcome of unknown , stiffness on the left side back of ear down her neck, shoulder and down arm and back of that blade with outcome of unknown , scapular pain with outcome of unknown , feeling of being warm then cold with outcome of unknown, it swells under the breastbone, severe pain after the vaccine right next to the sternum, below the neck that bone with outcome of unknown. Therapeutic measures were taken as a result of inflammation such as costochondritis and arthritis (inflammation), numb behind her ear, her shoulder, her arm, and the back of her shoulder blade (hypoaesthesia), the pain was unbearable (pain), stiffness on the left side back of my ear down my neck, shoulder and down arm and back of that blade (musculoskeletal stiffness), scapular pain (arthralgia) , feeling of being warm then cold (feeling of body temperature change), arthritis (arthritis), costochondritis (costochondritis). This is a follow up report, reference number: #. Consumer calling about the Pfizer COVID-19 vaccine who says she was completing a report with someone earlier but had to go to an appointment before that was finished. Caller said that the NDC was not provided for the Pfizer COVID-19 vaccine on her vaccine card, and for the LOT she can barely see it for the second dose. She says that the first dose LOT is EN6203, with EXP 30Jun2021, and the second dose LOT was EN6207, with EXP 31Jul2021. Caller said that she believes the agent she spoke to earlier put down every thing, and she thinks she took all the information from the second one. She said she became numb behind her ear, her shoulder, her arm, and the back of her shoulder blade. She said she stayed that way awhile, and treated it with a heat compress, ice, and anti-inflammatory medications. Caller said she had issues with inflammation, such as costochondritis and arthritis before getting the vaccine, but it elevated it say on a 10 to a 20. She said she was hospitalized for that two weeks ago, because the pain was unbearable, for the inflammation down her neck and chest, because they had to rule out a heart attack. She says what happened was her left shoulder or arm that got the injection, and she had costochondritis before the injection, but she never had with the numbness and pain down the side of her ear, neck, and bones. She clarifies that bones were her collarbones, and says that part was swollen, it just swells up, that's what it does. She says that they gave her anti-inflammatories and pain killers to quiet it, then two days ago it started to swell again. No further details provided about the anti-inflammatories or painkillers she took. Caller says she was supposed to speak to the medical team to ask them questions after the agent said she was not able to answer what was the cause of it, and the agent had gave her the number option 3. This is a follow up report. Attempted transfer to MI, caller requested to be transferred to the queue to wait for the next available representative, asked about any product complaint issues and medical information request, questioned about inflammation and pain. The outcome of all the event was unknown. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1320343
Sex: F
Age:
State: FL

Vax Date: 04/27/2021
Onset Date: 05/05/2021
Rec V Date: 05/15/2021
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: had rapid test that was Covid positive on 05May; headache; congestion and stuffy nose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 27Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05May2021, the patient experienced had rapid test that was covid positive on 05May. On an unspecified date in 2021, the patient experienced headache, congestion and stuffy nose. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Caller's daughter received 1st Pfizer vaccine on 27Apr. Daughter had negative Covid test the day prior to receiving 1st shot. Daughter had rapid test that was Covid positive on 05May with headache, congestion and stuffy nose. On 26Apr2021, the patient underwent lab test which included covid-19 test: negative and on 05May2021, the patient underwent lab test which included covid-19 test: negative. The patient did not receive any treatment for the events. The clinical outcomes of the had rapid test that was Covid positive on 05May, headache, congestion and stuffy nose were unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320344
Sex: M
Age:
State: PA

Vax Date: 04/25/2021
Onset Date: 05/02/2021
Rec V Date: 05/15/2021
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: Said her son startedexperiencing symptoms like cold,congestion, headache and scratchy throat on 05/02/2021and her son tested positive today05/05/2021.; Cold; Headache; Scratchy throat; Congestion; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient with unspecified age that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 25Apr2021 at 1st dose, single for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The consumer was calling on behalf of her son, got the first dose of the vaccine on 25Apr2021, and the second dose is scheduled 16May2021 (correct dosing schedule). Consumer said her son started experiencing symptoms like cold, congestion, headache and scratchy throat on 02May2021 and her son tested positive today 05May2021. Consumer wanted to know if we recommend getting her son's second dose as scheduled. Were any unaddressed medical questions referred or forwarded to Medical Information; Yes. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1320347
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient missed her 2nd Dose of the COVID-19 on 03May2021, because she tested positive with COVID 19 after her first shot of the COVID 19 Vaccine on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320348
Sex: F
Age:
State: PA

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 05/15/2021
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: heart flutters; heart palpitations; injection site was "sore"; swelling in the upper back part of [her] shoulder with a little numbness; swelling in the upper back part of [her] shoulder with a little numbness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0169) dose 1 via an unspecified route of administration, administered in left arm on 18Apr2021 12:00 as single dose for covid-19 immunization. Medical history included, cholecystectomy on 23Dec2020, she explained she had gallbladder surgery on 23 December, allergy to anything with codeine or codeine related , on 09Apr1951, Deformed tooth , preauricular cyst from 09Apr1951, Pre-audio congenital sinus , back pain, cerebrovascular accident, allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She Has holes in the top of her ear and sometimes they ooze a smelly discharge, jog until 2013. The family history included patient's Father passed away think stroke related , hypertension. Mother had high blood pressure and thinks she had angina; knows she had enlarged heart, but does not know what contributed to her death; sister may have those papers but caller was never provided with information of what direct cause of death was , cardiomegaly. Concomitant medications included ibuprofen sodium (IBUPROFEN [IBUPROFEN SODIUM]) taken for back pain; metoprolol (METOPROLOL) from 2013. The patient previously took beta blocking agents, flu vaccine vii. She explained the injection site was sore and she had swelling in the upper back part of her shoulder with a little numbness, which lasted 24 hours. She added 4 days after vaccination, she experienced heart palpitations, she could feel it, and heart flutters. She specified these symptoms started on 22Apr2021 at noon, then the next day she had it again, but it lasted longer than the previous day, and it lasted all day long the following day. She said she started feeling better this past Saturday, on 01May2021, then on the following Sunday she was even "better", and Monday through today, Friday she has not experienced the reported symptoms. She said her primary care doctor (PCP) has offered to increase her beta-blocker if her symptoms would worsen, and that her palpitation could be due to anxiety. She explained she disagreed with her PCP. She mentioned she has not experienced these symptoms when feeling anxious in the past. She added she cannot rely on her PCP and is attempting to change PCP. She explained her PCP recommended her to get the second dose of the vaccine and said, it's better than nothing or [she] won't be immunized. She mentioned her cardiologist, whom she is scheduled to see on 13May2021 said: she should go to the ER if her symptoms worsen, and she should get the second dose "if [she] feels comfortable". She explained her cardiologist sent that message to her through an unspecified intermediary after she informed him of her side effects from the vaccine. She specified she failed to obtain her cardiologist's recommendation on getting the COVID-19 vaccine prior to being vaccinated. She also mentioned she cannot take the Flu vaccine since she had a terrible experience the fourth year, she took it. She explained she took the flu vaccine for 4 consecutive years, the first year she was fine but the following year she reacted, and her reaction worsened after each year. She asked if she should take the second dose of the vaccine after experiencing side effects from the first dose. She explained she is left alone to make that decision and needs guidance. She reported a lot of her family members had no side effect except for a sore arm after getting the Moderna COVID-19 vaccine. Side effects after her second shot may be more intense than the ones you experienced after her first shot. These side effects are normal signs that your body is building protection and should go away within a few days. patient asked if side effects from a booster dose of the Pfizer-BioNTech COVID-19 vaccine could be more intense. Upon follow-up received on 07May2021, on 18Apr2021, patient had other symptoms (Unspecified), On 18Apr2021 about 1 hour after being administered the Pfizer-BioNTech Covid-19 Vaccine she was leaving the site and started feeling like a little stinging sensation in the area of the injection in left arm. Around 13:44 her left arm became sore. She wasn't sure, said maybe she shouldn't carry her handbag on that arm so she switched her handbag to her right arm. Sensation went from the injection site down to the elbow and it wasn't quite like a soreness; like sensation; then started to feel heavy around a little below injection site of left arm felt a little heavy maybe inch or so from where the needle was put in. She felt just kind of weird. She guesses a little bit later on is when left arm started to feel a little sore but wasn't anything bad like bad soreness; she could feel it but not like ouch. She recovered completely from these events, they didn't stay forever. By the time she was on the way home she felt soreness had gone away. She did have a swelling not at the injection site but from off the injection site to the back top part of the shoulder kind of a little numb; felt a little numb and swollen didn't last forever think it started 18Apr2021 and thinks event went away by the next day, 19Apr2021, recovered completely. Soreness of arm lasted a little bit when she got home it was hard to move her left arm up and down. She looked at the vaccine papers which showed those effects and advised to exercise the arm and apply ice; applying ice didn't do any good; but she worked in physical therapy so she started exercising the arm moving the arm and that. Recovered completely from all these events, further to date details unknown. On 22Apr2021 patient had heart palpitations, heart flutters. Patient had vaccine because something just hit her across the head guess because family members were getting it. She woke that morning and wasn't sure what happened, woke up feeling heart palpitations and heart flutters. The day she called the Cardiologist she was feeling lousy and that is when the Cardiologist relayed the message that if it got worse to call back or go to the emergency room. Cardiologist initially told her to contact her primary care physician and she thought why she would call her primary care physician when it's a heart problem she experienced; but she did call the primary care physician. Cardiologist and Primary Care Physician told her basically what she needs to do, and it was up to her whether to get the second dose of the Pfizer-BioNTech Covid-19 Vaccine. Each day it feels like her heart is getting back to normal, but it feels like her heart had been through the ringer with the heart palpitations and heart flutters. She reported these events have improved a lot but she is still not 100%, she would say probably 97% recovered at this time. It was an unknown if she will or will not be getting the second dose relative to these events. The outcome of events heart flutters, palpitations was recovering and sore, swelling, hypoesthesia was recovered. Additional information has been requested.

Other Meds: IBUPROFEN [IBUPROFEN SODIUM]; METOPROLOL

Current Illness: Drug allergy (Verbatim: Allergy to anything with codeine or codeine related); Pre-auricular sinus congenital (Pre-audio congenital sinus)

ID: 1320349
Sex: M
Age:
State: ND

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 05/15/2021
Hospital: Y

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: Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1320350
Sex: M
Age:
State:

Vax Date: 04/10/2021
Onset Date: 04/21/2021
Rec V Date: 05/15/2021
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: full body rash from the neck down; itchy and burned like crazy; burned like crazy; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported as rash after first dose and the patient received the first dose of the Pfizer Covid-19 vaccine on 10Apr2021, in which he reports everything went fine. On 21Apr2021, he broke out in a full body rash from the neck down, which was described as "itchy and burned like crazy." He states he took Benadryl for a few days, in which the pruritus went away, but the rash remained present. He states that he went to a dermatologist and internist, in which he was prescribed to take prednisone for 6 or 7 days, and the prednisone made the rash go away. He states he was scheduled for his second dose this past Saturday, in which the internist advised him to hold off since they were not 100 % sure if he should receive the second dose. He states he researched pictures online that presented rashes, and states his rash looked like the pictures, only more intense. He is asking if he should receive the second dose or not. He wanted to know what the efficacy after one dose is and asked how long he can wait to take the second dose. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1320351
Sex: F
Age:
State: IN

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/15/2021
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: Anaphylaxis reaction (itching, rash, tingling, insomnia); This is a spontaneous report from a contactable Nurse. This 75-years-old female Nurse (patient) reported herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an intramuscular route of administration, administered in arm left on 09Apr2021 09:45 at age of 75-year-old at a single dose for COVID-19 immunization. Medical history included ongoing hypertension and patient was diagnosed with high blood pressure probably 30 years ago. Patient reported that she was put on amlodipine because her other blood pressure medication wasn't keeping her blood pressure down. patient unable to provide details for blood pressure medication she took before amlodipine, ongoing reflux gastritis patient reported that she was diagnosed with acid reflux 25 years ago, ongoing osteoporosis patient was diagnosed with osteoporosis 3.5 years ago, ongoing scoliosis patient was diagnosed with scoliosis as a child when she was 11 years old. Patient reported that she had surgery 3.5 years ago and her spine was fused from T3 to her coccyx. Patient reported that when she was diagnosed with scoliosis, the doctors back then said that surgery was too drastic. Patient reported that an orthopedic back specialist advised her parents not to let anyone touch the caller, ongoing blood cholesterol increased patient was diagnosed with high cholesterol a year and a half ago, hysterectomy from an unknown date and unknown if ongoing Caller reported that she had a hysterectomy when she was 40. Family Medical History Relevant: Caller reported that she has a grandson that has a severe reaction to tree nuts. Caller reported that her grandson is the only one in her family that she knows of that has a severe allergy to something specific. The patient did not have a history of any previous allergies to specific products or any conditions indicative of an allergy. Concomitant medications included calcium taken for hysterectomy from an unspecified start date and ongoing, esomeprazole taken for reflux gastritis from an unspecified start date and ongoing, Atorvastatin taken for blood cholesterol from an unspecified start date and ongoing, losartan potassium taken for blood pressure measurement from an unspecified start date and ongoing, amlodipine besylate taken for blood pressure measurement from an unspecified start date and ongoing, alendronate sodium taken for osteoporosis from an unspecified start date to Apr2021. Calcium: Caller reported that she has been taking Calcium for years. Fosamax: Caller reported that her doctor cancelled the Fosamax because it was causing a problem with reflux, burning and so forth. Caller reported that her physician is trying to get her one something that is given by an infusion once a year to replace the Fosamax. Caller reported that she took the Fosamax in the morning with water, no food, and didn't lay down afterward. Caller reported that she knew that it would cause problems if she laid down after taking the Fosamax. Fosamax Product Info: NDC: 69097-224-16, Lot Number: GC00501, Expiration Date: Apr2023. Caller reported that she used another medication for 2 years before Fosamax that was given via injection that can only be given for 2 years. Losartan: Caller reported that she was on another blood pressure medication and the pharmacy called and told the caller to stop taking that blood pressure medicine. Caller reported that the pharmacy informed her that they had gotten reports that her blood medication was bad medication. Caller reported that she received the medication and phone call from the Pharmacy. Caller reported that the pharmacy instructed her not to take any more of the blood pressure medication and to go back to her doctor and have him prescribe something else. Caller reported that the pharmacy informed her that the product had something in it that is not good for your health. Caller was queried for details on her old blood pressure medication. Caller reported that she threw the medication in the trash because the pharmacy explained that it could be deadly to her health. Caller unable to provide details of the blood pressure medication she took before Losartan. Scoliosis: Caller reported that her brother found out that there are surgeons that are taking care of scoliosis in older patients at the hospital. Caller reported that she had the surgery done and it has allowed her to have her life back because she was going down very fast in what she could do. Caller reported that the pain was just too much at times. Caller reported that her quality of life was poor and now it's very good. Caller reported that she didn't go to see her physician for the rash or itching, she just took Benadryl and waited it out. The patient did not receive any recent vaccines for any other conditions prior to the event being reported, the patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer BIONTECH COVID-19 Vaccine prior to the event being reported, the patient did not received any other vaccines around the time of the Pfizer BIONTECH COVID-19 Vaccine vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced anaphylaxis reaction, (itching all over just severely from head to toe, small rash on back, lips tingle a little) on 09Apr2021, patient itching so bad she couldn't sleep. Patient reported that she received her first dose of the Pfizer Covid-19 vaccine on 09Apr2021. She was supposed to have her second dose of the Covid-19 vaccine today, 07May2021, but she called and cancelled the appointment. The lady that gave the caller the Covid-19 vaccine called her wondering why she had cancelled her appointment. Patient had a reaction from the first dose of the Covid-19 vaccine where she was itching all over just severely from head to toe. Patient was miserable and took Benadryl. Patient reported that the Benadryl helped her get to sleep. Patient reported that she also had a small rash on her back that she put Benadryl cream on. Patient reported that the rash lasted 2 days or so. Patient reported that she has a little itching now but it's nothing, the itching could be just normal for her. Patient reported that for 2 days the itching was not normal at all, it was severe itching. Patient reported that she didn't know if she should even have the second dose of the Covid-19 vaccine following her reaction to the first dose. Patient reported that she called the pharmacist who instructed the caller to call her physician. Caller reported that she called her physician and he informed the Patient that there is not enough information for him to be able to tell the caller what she should do. Caller reported that she asked her physician if she took a Benadryl before she went to get the second dose of the Covid-19 vaccine and took someone with her to the vaccination facility, would that be enough. Patient reported that her physician informed her that he would definitely recommend that the caller take Benadryl if she gets the second dose of the COVID-19 vaccine, but would not tell the caller whether or not she should get the second dose. Patient reported that she didn't know how long you had to decide to get the second dose of the Covid-19 vaccine or not. Caller reported that someone told her that you have 3 weeks after the first dose of the Covid-19 vaccine and 3 weeks after you're supposed to have the second dose. Caller inquired how much longer she has to decide whether or not to get the second dose of the Covid-19 vaccine. Patient reported that the itching began about 5 hours after she received the first dose of the Covid-19 vaccine on 09Apr2021 and the itching was severe for at least 2 days. Patient he has itched a little here and there, patient is always out in the yard doing something. Patient nose itched so bad that she couldn't stand it, not having any trouble with breathing and lips tingled a little and she wondered if that was just from itching. Patient was trying to use her knowledge to figure all of this out on her own. Caller reported that's all sh

Other Meds: CALCIUM; ESOMEPRAZOLE; ATORVASTATIN; LOSARTAN "AGP"; AMLODIPINE BESYLATE; FOSAMAX

Current Illness: Blood pressure high (Caller reported that she was diagnosed with high blood pressure probably 30 years ago. Caller reported that she was put on amlodipine because her other blood pressure medication wasn't keeping her blood pressure down. Caller unable to provide details for blood pressure medication she took before amlodipine.); High cholesterol (Caller reported that she was diagnosed with high cholesterol a year and a half ago.); Osteoporosis (Caller reported that she was diagnosed with osteoporosis 3.5 years ago.); Reflux gastritis (Caller reported that she was diagnosed with acid reflux 25 years ago.); Scoliosis (Caller reported that she was diagnosed with scoliosis as a child when she was 11 years old. Caller reported that she had surgery 3.5 years ago and her spine was fused from T3 to her coccyx. Caller reported that when she was diagnosed with scoliosis, the doctors back then said that surgery was too drastic. Caller reported that an orthopedic back specialist advised her parents not to let anyone touch the caller.)

ID: 1320352
Sex: M
Age:
State: TX

Vax Date: 04/19/2021
Onset Date: 04/29/2021
Rec V Date: 05/15/2021
Hospital: Y

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: coma; Basilar artery thrombosis; This is a spontaneous report from a contactable consumer. A 54-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 10:00 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included psoriatic arthritis from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included metronidazole; sulfasalazine; lamotrigine and trazodone all taken for an unspecified indication, start and stop date were not reported. On 29Apr2021 06:00, 10 days after the first shot, the patient experienced come due to a basilar artery thrombosis. The event required emergency room/department or urgent care visit where the patient was subsequently brought to the ICU. The patient received unspecified treatment for the events. The outcome of the event was not recovered. Follow up attempts needed. Further information is expected.

Other Meds: METRONIDAZOLE; SULFASALAZINE; LAMOTRIGINE; TRAZODONE

Current Illness:

ID: 1320353
Sex: M
Age:
State: NJ

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 05/15/2021
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: Paralysis of left arm.; Extreme pain in left shoulder and arm for 6 weeks and counting.; Extreme pain in left shoulder and arm for 6 weeks and counting.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route, administered in left arm on 23Mar2021 at 09:00 (Lot Number: EP6955) at the age of 36-year-old as SINGLE DOSE for COVID-19 immunization. The patient did not have any relevant medical history and concurrent conditions. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced paralysis of left arm, extreme pain in left shoulder and arm for 6 weeks and counting. The patient visited to the emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit due to the reported events. Therapeutic measure was taken for the reported events included unspecified medication and physical therapy. The outcome was reported as not recovered for the reported events.

Other Meds:

Current Illness:

ID: 1320354
Sex: M
Age:
State: FL

Vax Date: 04/30/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Began to have pain in hip that progressed to severe pain and parlaying leg and foot; Unable at 2 nd week to stand or walk; Unable at 2 nd week to stand or walk; Began to have pain in hip that progressed to severe pain and parlaying leg and foot; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 30Apr2021 at 15:30 (at the age of 27 years) as unknown dose, single for COVID-19 immunization. Medical history included obesity and mental illness. Concomitant medications included aripiprazole (ABLIFY), sertraline hydrochloride (ZOLOFT), metformin, bupropion hydrochloride (WELLBUTRIN), simvastatin and lisinopril. 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 and since the vaccination, it was unknown if the patient was tested for COVID-19. The patient was hospitalized on 27Apr2021 for an unknown reason and began to have pain in hip that progressed to severe pain and parlaying leg and foot on 03May2021. Unable at the second week to stand or walk. These adverse events result in emergency room (ER) or department or urgent care. The patient's hospitalization was prolonged and the patient was disability as a result of these events. It was unknown if the treatment was received by the patient due to these events. It was reported that the duration of hospitalization was 10 days discharged on 07May2021 (also reported as continued, CLARIFICATION PENDING). The outcome of all these events was not recovered at the time of report. Information on the lot/batch number has been requested.

Other Meds: ABILIFY; ZOLOFT; METFORMIN; WELLBUTRIN; SIMVASTATIN; LISINOPRIL

Current Illness:

ID: 1320355
Sex: F
Age:
State: CA

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Acute Hemmoragic Pancreatitis; This is a spontaneous report from a contactable healthcare professional (patient). This 50-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EWO175) on 24Apr2021 at 11:15 (at 50 years of age), in left arm, for COVID-19 immunization. Medical history included hypertension, obesity and cholecystectomy. Known allergies: no. The first dose of BNT162B2 vaccine was given on 03Apr2021 at 11:00 AM (at 50 years of age), in left arm, Lot number: ER8734. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and Areds2-eye vitamin/mineral supplement. On 25Apr2021 at 15:00 the patient experienced acute hemmoragic pancreatitis. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 4 days, life threatening illness (immediate risk of death from the event). The event required treatment with IV fluids, morphine, norco. The patient was recovering at the time of report. Since the vaccination, the patient had been tested for COVID-19: (SARS-COV-2 NAA (COVID-19) nasal swab) on 26Apr2021 with negative result.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported event acute hemorrhagic pancreatitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TYLENOL

Current Illness:

ID: 1320357
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
Hospital: Y

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: cough; chest hurts; clots on both legs and stomach; hemorrhage; Blood sugar decreased; Oxygen saturation low; Blood pressure low; Skin discoloration; vein on her right leg was torn; Difficulty breathing; Tiredness; Breast pain; blockage all over the heart; This is a solicited report from A contactable consumer (patient) based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3840719-00). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 27Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 2005 (Batch/Lot number was not reported) to Feb2021, at 40 mg/0.4 ml, then subcutaneous from 21Apr2021 (Batch/Lot number was not reported) and ongoing, at 40 mg 1 in 2 week for moderate to severe rheumatoid arthritis psoriatic arthritis. Medical history included patient consumed a pack of cigarette a day from 1967 to 2019, heart attack from 2003 to 2003, abstains from alcohol, and high blood pressure. Concomitant medication included metoprolol taken for high blood pressure. The patient previously took metformin to manage blood sugar. On an unspecified date, the patient experienced cough, chest hurts, clots on both legs and stomach. In 2010, the patient experienced breast pain and blockage all over the heart. She first tried to do the balloon and had three stents on her heart due to blockage sometime in 2010. In Jan2021, the patient had bypass surgery as treatment heart blockage as well. On 18Feb2021, echocardiogram/ECHO showed blockage all over the heart again. In 2021, the patient had difficulty breathing and experienced tiredness easily. In Mar2021, she was told to have an outpatient diagnostic heart catheter procedure and they had to take her by ambulance to be admitted in a hospital, when she moved during the procedure, a vein on her right leg was torn and also had hemorrhage, blood sugar decreased, oxygen saturation low, blood pressure low, skin discoloration. She experienced a recurring pain in between the breast bone after the triple bypass surgery that was done last 09Mar2021 while in the hospital. She also had blood transfusions while hospitalized as treatment for hemorrhage. The patient was hospitalized for the events for 28 days (also reported as 4 weeks). The event vein on her right leg was torn was considered life threatening. The events breast pain, blockage all over the heart, difficulty breathing, tiredness, hemorrhage, blood sugar decreased, oxygen saturation low, blood pressure low, and skin discoloration were also considered medically significant. The patient underwent lab tests and procedures which included stress test and echocardiogram/ECHO with unknown result in Jan2021; echocardiogram/ECHO showed blockage all over the heart on 18Feb2021; blood sugar: decreased, blood pressure: low, and oxygen saturation: low, all in Mar2021. The action taken in response to the events for adalimumab was dose not changed. The outcome of vein on her right leg was torn was recovered in Apr2021; hemorrhage and skin discoloration were recovered in Mar2021; clots on both legs and stomach, difficulty breathing, tiredness, blood sugar decreased, oxygen saturation low, blood pressure low was recovering; breast pain, blockage all over the heart was recovered on an unspecified date, while other events was unknown. Causality: Drug : Humira 1.Vein on her right leg was torn Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 2.Clots on both legs and stomach Causality as per reporter (Drug/Vaccine) : Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 3.Blockage all over the heart Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 4.Difficulty breathing (Dyspnoea) Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 5.Hemorrhage Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 6.Breast pain Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 7.Skin discoloration Causality as per reporter (Drug/ Dose Not Changed) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 8.Blood pressure low Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 9.Cough Causality as per reporter (Drug/Vaccine) : Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 10.Oxygen saturation low Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 11.Blood sugar decreased Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 12.Chest pain Causality as per reporter (Drug/Vaccine) : Not Reported Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility 13.Tiredness Causality as per reporter (Drug/Vaccine) : Not Related Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility Causality: Covid-19 Vaccine 1.Vein on her right leg was torn Causality as per reporter (Drug/Vaccine) : Not Related 2.Clots on both legs and stomach Causality as per reporter (Drug/Vaccine) : Not Reported 3.Difficulty breathing Causality as per reporter (Drug/Vaccine) : Not Related 4.Hemorrhage Causality as per reporter (Drug/Vaccine) : Not Related 5.Breast pain Causality as per reporter (Drug/Vaccine) : Not Related 6.Skin discoloration Causality as per reporter (Drug/Vaccine): Not Related 7.Blood pressure low Causality as per reporter (Drug/Vaccine) : Not Related 8.Cough Causality as per reporter (Drug/Vaccine) : Not Reported 9.Oxygen saturation low Causality as per reporter (Drug/Vaccine) : Not Related 10.Blood sugar decreased Causality as per reporter (Drug/Vaccine) : Not Related 11.Chest pain Causality as per reporter (Drug/Vaccine) : Not Reported 12.Tiredness Causality as per reporter (Drug/Vaccine) : Not Related 13.Blockage all over the heart Causality as per reporter (Drug/Vaccine) : Not Related Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.

Other Meds: METOPROLOL; HUMIRA

Current Illness: Smoker

ID: 1320358
Sex: F
Age:
State: FL

Vax Date: 01/11/2021
Onset Date: 05/01/2021
Rec V Date: 05/15/2021
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: she started to have shortness of breath in the evening; She realized she couldn't do as much as she normally does. She said she tried; Tested positive for Covid-19 after both doses of Covid-19 Vaccine; she tested positive for the COVID-19 Virus on 05May2021; Now she had zero taste and smell; Now she had zero taste and smell; she had congestion; This is a spontaneous report from a contactable other-HCP. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1284 and expiration date was not reported), via an unspecified route of administration in deltoid left on 11Jan2021 as 2nd single dose, for COVID-19 immunization. Medical history included hypertension from 2015 and ongoing, hyperthyroidism from Aug2019 and ongoing, ongoing seasonal allergy stated she has had seasonal allergies since she was a kid. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number-EH9899 and expiration date was not reported), via unspecified route of administration on 20Dec2021 for COVID-19 immunization. On 05May2021 the patient experienced tested positive for COVID-19 after both doses of covid-19 vaccine. Upon follow-up received on 07May2021, she tested positive for the covid-19 virus on 05May2021. The patient now she had zero taste and smell (ageusia) (medically significant) the patient the patient with outcome of not recovered, On May2021 the patient experienced now she had zero taste and smell, she said she had congestion and couldn't taste and smell. She said on 06May2021 she started to have shortness of breath in the evening. She said because she was a cardiopulmonary specialist, she thought her shortness of breath was mild, but her family members thought she sounded winded. She said yesterday, she realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor because she was short of breath. She said she doesn't feel sick. She realized she couldn't do as much as she normally does. She said she tried to mop the floor yesterday and couldn't finish mopping the floor-Activities of daily living impaired. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05May2021, sars-cov-2 test positive: positive on 05May2021. Therapeutic measures were taken as a result of now she had zero taste and smell (ageusia), now she had zero taste and smell (anosmia), she had congestion (nasal congestion), she started to have shortness of breath in the evening (dyspnoea), she realized she couldn't do as much as she normally does. she said she tried (loss of personal independence in daily activities). The outcome of event was Not recovered. Follow-up(07May2021): New Information received from the contactable consumer includes updated events and dates, Past drug events and allergy and questions regarding events. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Vaccination failure,Covid19,loss of smell,taste. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds:

Current Illness: Hypertension; Hyperthyroidism; Seasonal allergy (Stated she has had seasonal allergies since she was a kid.)

ID: 1320360
Sex: M
Age:
State: PA

Vax Date: 04/23/2021
Onset Date: 05/04/2021
Rec V Date: 05/15/2021
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: Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Apr2021 18:00 (at the age of 46-year-old) (Lot Number: EW0170) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. 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 was diagnosed with bells palsy on 04May2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diagnosed with bells palsy, medication steroid and antiviral were used. Event outcome was not recovered.

Other Meds:

Current Illness:

ID: 1320361
Sex: F
Age:
State: TX

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 05/15/2021
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: anaphylaxis; This is a spontaneous report received a contactable consumer (patient) from a 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EP6955, expiry date not reported) via an unspecified route of administration on 30Mar2021 as first dose, single for covid-19 immunisation. Medical history included asthma and autoimmune disorder, both from an unknown date and unknown if ongoing. Patient received her 1st dose on 30Mar2021 but experienced a bad reaction (anaphylaxis) on an unspecified date in 2021. She was afraid to take her 2nd dose since its risky. She was asking if she can take an alternative vaccine for her 2nd dose (Moderna) or she needs to stop. She needed to know how to move forward for dose 2. She needed hospitalizing and it was to the point she needed to call 911 but it resolved and materialized at home. She clarified that instead of going to the hospital it was a close call at home. She said she used her rescue inhaler because she was an asthma person. She used her rescue inhaler over the course of a few days and it resulted in settling the issue. It lasted several days. She needed to also submit a safety report over to VAERS. She wanted to submit over there as well, online or call in. Her question was she had a really bad case and nearly had to go to the ER and thought she would die with dose 1, she waned to know if she should get dose 2. She looked it up through the CDC and it says do not continue dose if she had anaphylaxis. She reached out because she does not feel comfortable about the adverse effects. If she experienced adverse effects, she asks if she can get a different vaccine. The CDC website says she may chose to take different vaccine. She wants to know if she can take another vaccine. She wants to know what's in the Pfizer vaccine, asking what are in the ingredients. Right now, she has one vaccine in the system. She wanted to know how effective is it to prevent her from catching covid. How much protection does she have from one dose. The lady just read the statement to her that people who are immunocompromised she was told something that it would have a lower effect with the vaccine. She would like to file an official report with VAERS she wants to receive the information she needs about the vaccine through Pfizer and move forward. She contacted the CDC and usually with adverse effects Pfizer uses the reports of the vaccine. If she has need or medical assistance needed or she doesn't know reimbursement billing. If a medical fee was incurred. She said she had to get a chest x-ray on an unknown date with unknown result and it was an emergency she had to go to the doctor which was a medical expense. She wanted to know if she will be refunded. There is compensation on the FDA's website. On the website from the CDC that says Pfizer has compensation for reaction for the shot for medical expenses. She was informed that she would have to submit a written request to the legal department by mail. She repeatedly asked for a direct phone number for the legal department. She stated her lawyer would not know how to file the claim she would be mailing to them and asked if there is a website to know how to file the claim. Her legal papers. She stated Pfizer cannot be sued they are covered by the government. She wanted to know how effective is it to prevent her from catching covid and stated "the lady just read the statement that people who are immunocompromised have a lower effect with the vaccine". The event was reported as medically significant and life-threatening and patient stated that it had caused her for a physician visit. The patient recovered from anaphylaxis on an unspecified date in 2021.

Other Meds:

Current Illness:

Date Died:

ID: 1320362
Sex: M
Age:
State: MS

Vax Date: 05/06/2021
Onset Date: 05/07/2021
Rec V Date: 05/15/2021
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: patient passed away, due to what was being told as possible blood clot in lungs; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06May2021 (Lot Number: ER8633) (at the age of 70-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not experienced COVID-19 prior or post vaccination. The patient passed away, due to what was being told as possible blood clot in lungs (on 07May2021). The event was serious (fatal) and required emergency room visit. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: blood clot in his lungs

Other Meds:

Current Illness:

ID: 1320363
Sex: F
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 05/15/2021
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: Bell's Palsy; The patient was pregnant at the time of vaccination/Delivery date would be on 06Jun2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm, on 24Mar2021 (Lot Number: ER8132, at the age of 44-year-old) as single dose, for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 03Mar2021 (Lot Number: EN6199, at the age of 44-year-old) as single dose for covid-19 immunization and experienced pregnant at the time of vaccination. The patient was pregnant at the time of vaccination. Gestation period was 30. Delivery date would be on 06Jun2021. The patient experienced bell's palsy on 08May2021. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care due to the event. Treatment included steroid prescription. Patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Patient had no other vaccine in four weeks. The outcome of the event Bell's Palsy was recovering.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1320364
Sex: M
Age:
State: SC

Vax Date: 01/18/2021
Onset Date: 02/01/2021
Rec V Date: 05/15/2021
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: COVID-19 virus test positive; COVID-19 virus test positive; cough; weak; headache; sinus issues; tiredness; This is a spontaneous report from a contactable female consumer. This 74-year-old male consumer (patient) reported that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3246) via an unspecified route of administration into the right arm on 18Jan2021 (at the age of 74-year-old) as single dose for COVID-19 immunisation. The patient medical history included ongoing overweight, blood pressure, thyroid and diabetes. On an unspecified date, COVID 19 virus test was positive. Concomitant medications were not reported. The patient reported that he came down with the Covid-19 virus on 01Feb2021 and tested positive for the Covid 19 virus on 03Feb2021 with the swab in his nose and he received his positive results in the afternoon on 04Feb2021. He started having symptoms on 01Feb2021. He had a cough, headache, sinus issues and tiredness. He had no fever. His symptoms only lasted until about 05Feb2021, except for the tiredness. He was tired and weak for about 6 weeks. The caller received his second Covid 19 vaccine in the right arm on 19Feb2021. The needle did not hurt for his second vaccine but the injection part hurt for a good 24 to 36 hours. He meant it hurt, just at the injection site and he did not feel the needle, but he felt pressure at the injection site and it started hurting immediately. That night, 19Feb2021, he had a little fever and he started coughing again and he had a headache. He remembers because he got up in the middle of the night. The next morning, 20Feb2021, the fever, coughing and headache were gone. Only his injection site was bothering him. He takes medicines but does not think his medications are relevant. He has routine blood work done every 6 months and his doctor told him he was healthy. He reported he does not exercise and both he and his wife were tested for the Covid 19 virus at a 360 degree mini-hospital. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no vaccines administered on same date with the Pfizer vaccine considered as suspect. No following prior vaccinations. The reporter called for his wife who had a history of cancer. She received her first dose of the Covid 19 vaccine on 18Jan2021. Then she and the reporter both tested positive for the Covid 19 virus. He got his second Covid 19 vaccine. His wife was not able to get her second dose and enquired when will she be able to get her second vaccine. She was hospitalized and was still following up with her doctors getting chest x-rays because her doctor said the Covid 19 virus was still in her system even though she was not having any symptoms. Before she got her second Covid 19 vaccine, both tested positive for the Covid 19 virus. She was worse than he was and was not admitted to the hospital, she went to the hospital at the advice of her lung doctor to receive an infusion and was only at the hospital for 3 hours getting the infusion. At that point she had to wait 90 days to receive her second Covid 19 vaccine. If she had no symptoms, she would be able to get it. Her 90 day time frame was up yesterday, 05May2021 and she received her second Covid 19 vaccine yesterday. He reports the CDC and her lung doctor and primary care doctor all had different answers when it came to deciding when she could receive her second vaccine. Her doctors have said she still had the Covid 19 virus and had been treated with steroids and inhalers and had chest x-rays. She feels like she has a lot of weight on her chest and she was coughing constantly. There was some confusion if having to wait more than 42 days between Covid 19 vaccines will require a third vaccine. This report is not related to a study or programme. Investigation Assessment was reported as yes. Outcome was recovered for events cough, headache, sinus issues on 05Feb2021. Outcome was unknown for events drug ineffective, Covid-19, tiredness and weak. Follow up attempts are needed, further information has been requested.

Other Meds:

Current Illness: Blood pressure (Verbatim: Blood pressure); Diabetes (Verbatim: diabetes); Overweight (Verbatim: overweight); Thyroid disorder (Verbatim: thyroid)

ID: 1320365
Sex: F
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 04/03/2021
Rec V Date: 05/15/2021
Hospital: Y

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: Pulmonary embolisms; This is a spontaneous report received from a contactable consumer reported for herself (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 01Apr2021 11:00 (lot number: ER8733), at the age of 73-years-old, at single dose (unknown dose number) for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered. Patient medical history included high cholesterol, penicillin allergy, and high blood pressure. Concomitant medications included atorvastatin, valsartan, vitamin D3 and vitamin C (ascorbic acid). The patient previously took erythromycin for unspecified indication and experienced allergy. Patient was not pregnant at the time of vaccination. On 03Apr2021 at 15:00 (also reported as 36 hours after receiving the vaccine; pending clarification), patient experienced pulmonary embolism. The event was described as: patient developed shortness of breath and went to the hospital ER and was diagnosed with pulmonary embolism. The patient was then admitted to hospital on unspecified date (number of days of hospitalization was 5 days). The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment was received for the event which included apixaban (ELIQUIS). Outcome of the event was recovering.

Other Meds: ATORVASTATIN; VALSARTAN; VITAMIN D3; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1320366
Sex: M
Age:
State: NY

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 05/15/2021
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: 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; 2 hours after 2nd dose, I started to cough and wheeze and felt my throat was closing.; Received First dose on 03Apr2021, Second dose on 17Apr2021; Received First dose on 03Apr2021, Second dose on 17Apr2021; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Apr2021 17:00 (at age of 55 years old) (Lot Number: EW0172) as single dose for covid-19 immunisation. The patient other medical history was none. No known allergies. The patient's concomitant medications was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no other medications the patient received within 2 weeks of vaccination. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in arm left on 03Apr2021 17:00 (Lot Number: EW0150), also at age of 55 years old for covid-19 immunization. The patient reported that 2 hours after 2nd dose, he started to cough and wheeze and felt his throat was closing. He didn't want to go to the hospital and it felt better after his wife gave him diphenhydramine (BENADRYL). Adverse event start date was reported as on 24Apr2021 19:00 (CLARIFICATION PENDING). Events were reported as non-serious. AE treatment was reported as "no" (CLARIFICATION PENDING). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event outcome was recovered in Apr2021.

Other Meds:

Current Illness:

ID: 1320367
Sex: M
Age:
State: CA

Vax Date: 04/27/2021
Onset Date:
Rec V Date: 05/15/2021
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: he had some issue not like headache just mental issue that he didn't feel like in head; he started smoking after again after quitting; This is a spontaneous report from a contactable consumer. This consumer reported for a 70-year-old male patient. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0171 and expiry date: 31Aug2021), via an unspecified route of administration, in Arm Left, on 27Apr2021 at 16:27, as a single dose for COVID-19 immunization. The patient's medical history included COPD, Schizophrenia, UTI (took antibiotics), traumatic brain injury (when he was 16 or 17) and indwelling urinary catheter. Concomitant medication included Haloperidol for Schizophrenia, salbutamol (ALBUTEROL) for COPD, Diazepam, Trazodone for sleeping, and Ipratropium (Nebulizer). The reporter (care giver) stated that, the reporter spoke with a gentleman this morning about the adverse reaction that the reporter's partner had, he was nonverbal that's why the reporter was calling to check. The patient had his vaccine in the evening at 04:27, on 27Apr2021. He had around 08:30 quarter 9 and we were driving home around 9 o'clock and the reporter asked to patient that was he feeling weird, and the patient said yes. The reporter asked how the patient feeling weird. The patient said, in his head because he had this problem with his brain from his accident done, it was a little tricky because it was been years to start functioning in a way that he could relate to. The patient felt weird and low and he said his head, so he had some issue not like headache just mental issue that he didn't feel like in head, and he said today that's starting to go away that because the reporter asked him the question so the reporter just wondering if, he suggest when the reporter talk to the man early this morning and reported it. An hour, he took all the medicine he was taking and also his information. The reporter was wondering, he told the reporter to contact him for medical information and he gave the reporter this no to call him and he transfer the reporter and the reporter already too busy. The reporter already been over the phone so, the reporter would like to know if the reporter could help him to move this out of his system if that happen and the reporter would probably ask him not to have the second vaccine. The reporter wanted to know how he feel about that. When the reporter goes off, he was not the happy person actually. The patient started smoking after again after quitting 20 years ago after the vaccine. The reporter also stated that the patient said he was little better. The patient took little bit of Ganja by mouth not smoking it, that he made Ganja medicine and took little bit of that. He was taking it some of the local dispensary CBD and THC. The patient did not receive any treatment for the events. There was not a product complaint to report. There was a medical information request. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: HALOPERIDOL; ALBUTEROL [SALBUTAMOL]; DIAZEPAM; TRAZODONE; IPRATROPIUM

Current Illness:

ID: 1320369
Sex: M
Age:
State: FL

Vax Date: 01/01/2021
Onset Date: 05/02/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: fever of 103/104; Oxigen level of 82 / 84; No antibodies against COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, in Jan2021, at single dose, for COVID-19 immunisation. Patient had no known allergies or other medical history. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), lamotrigine (LAMICTAL), simvastatin (unknown manufacturer). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation on unknown date in right arm. The patient experienced fever of 103/104 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, oxygen level of 82 / 84 (caused hospitalization, life threatening) on 02May2021 at 08:00 AM with outcome of unknown, no antibodies against COVID-19 (life threatening) on 03May2021 with outcome of unknown. The events pyrexia and oxygen saturation decreased required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia and oxygen saturation decreased and included treatment with oxygen, antibiotics, fluids. After 8 hours the patient was sent to the ICU. The patient underwent lab tests and procedures which included body temperature: 103 on 02May2021, body temperature: 104 on 02May2021, oxygen saturation: 84 on 02May2021, oxygen saturation: 82 on 02May2021, COVID-19 antibody test: negative on 03May2021. The information on the lot/batch number has been requested.

Other Meds: PRISTIQ; LAMICTAL; SIMVASTATIN

Current Illness:

ID: 1320370
Sex: M
Age:
State: GA

Vax Date: 03/24/2021
Onset Date: 05/06/2021
Rec V Date: 05/15/2021
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: Diagnosed with Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration at the age of 43-year-old administered in left arm on 24Mar2021 18:00 (Lot Number: ER8730) as single dose for covid-19 immunisation. The patient previously took the first dose of BNT162B2 and administered in left arm at the age of 43-year-old on 24Feb2021 18:00 (Lot Number: EL9261) for covid-19 immunisation. Medical history included hypertension. No known allergies. Concomitant medication included bisoprolol fumarate, hydrochlorothiazide (ZIAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with bell's palsy on 06May2021 05:00. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Therapeutic measures were taken as a result of diagnosed with bell's palsy as treatment of antiviral and steroids. The outcome of the event was recovering.

Other Meds: ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]

Current Illness:

ID: 1320372
Sex: F
Age:
State: NH

Vax Date: 02/15/2021
Onset Date: 05/05/2021
Rec V Date: 05/15/2021
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: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in arm left on 26Jan2021 at the age of 43-years-old (Lot Number: EL3247) as single dose, 2nd dose via an unspecified route of administration, administered in arm right on 15Feb2021 at the age of 43-years-old (Lot Number: EL3247) as single dose, for COVID-19 Immunization. Patient was not pregnant. The patient's medical history was not reported. There was no any other medications within 2 weeks of vaccination. 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. Reported event was COVID-19 confirmed by positive COVID-19 test, with onset date 05May2021. COVID 19 test on 07May2021 was positive. There was not any treatment for AE. The outcome of event was recovering.

Other Meds:

Current Illness:

ID: 1320373
Sex: F
Age:
State: AL

Vax Date: 04/06/2021
Onset Date: 04/25/2021
Rec V Date: 05/15/2021
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: She tested positive for covid 19; She tested positive for covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Right Arm on 06Apr2021 as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 25Apr2021 the patient tested positive for covid 19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Apr2021. Therapeutic measures were taken as a result of tested positive for covid 19. The outcome of event was unknown. Follow-up (10May2021): New Information received from the contactable consumer includes updated events and dates, questions regarding events. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1320375
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/29/2021
Rec V Date: 05/15/2021
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: second dose outside of 42 days; diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer COVID vaccine on 15Mar2021 and then diagnosed with COVID-19 on 29Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Mar2021. The reporter was calling on 10May2021 and wanted to find out when could the patient receive the second dose of the Pfizer COVID vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and COVID-19 and the suspect drug.

Other Meds:

Current Illness:

ID: 1320376
Sex: F
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: autoimmune (Coombs positive) hemolytic anemia; idiopathic thrombocytopenia purpura; This is a spontaneous report from a contactable physician. An 89-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The patient experienced autoimmune (Coombs positive) hemolytic anemia as well as idiopathic thrombocytopenia purpura in Mar2021 with outcome of recovered in 2021. The patient was hospitalized for both events from 2021 to an unknown date. The patient received Prednisone, IVIG as treatment. The events also resulted in Emergency room/department or urgent care and considered as Life threatening illness (immediate risk of death from the event). Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported autoimmune (Coombs positive) hemolytic anemia as well as idiopathic thrombocytopenia purpura and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320377
Sex: M
Age:
State: NE

Vax Date: 04/17/2021
Onset Date: 05/02/2021
Rec V Date: 05/15/2021
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: Face was paralyzed/Bells palsy; Tongue felt fat and my lips numb; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Right on 17Apr2021 10:30AM, as 1ST DOSE, SINGLE for covid-19 immunization. Patient did not have medical history and no known allergy. Concomitant medication's included meloxicam and Multivitamins. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 02May2021, (reportedly patient stated that, 8 days after the vaccination), his tongue felt fat, and had lips numb. 2 days later symptoms spread. By Wednesday 05May2021 his face was paralyzed. He went to my physician the next morning and was told he have Bell's palsy. Patient states that, my face may never be normal again. AE resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of adverse events as prednisone 20 mg twice a day. Outcome of the events was not recovered.

Other Meds: MELOXICAM; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

Date Died: 04/12/2021

ID: 1320378
Sex: M
Age:
State: FL

Vax Date: 03/20/2021
Onset Date: 03/01/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death/natural process

Other Meds: INSULIN; SIMVASTATIN; HYDROCHLOROTHIAZIDE; COREG; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1320379
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had 2 seizures; This is a spontaneous report from a contactable consumer (parent). A 16-year-old male patient received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on an unknown date at 2nd dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received bnt162b2 (lot/batch number unknown) via an unspecified route of administration on an unknown date at 1st dose, single for COVID-19 immunization. The patient had 2 seizures after receiving his 2nd dose of the Pfizer vaccine. The seizures occurred approximately 15 hours after the vaccine was given. He has no underlying seizure condition. The event was reported as serious for Life-threatening. The outcome of event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1320380
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 05/15/2021
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: angioedema; hives; in lips tingling at times; itching; rash; This is a spontaneous report from a non-contactable other hcp. A 33-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) dose 1 via an unspecified route of administration on Dec2020 (at the age of 32-year-old) as single, and dose 2 via an unspecified route of administration on Jan2021 as single for covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. On 2021, Reporter's daughter had the first Pfizer vaccine in DEC 2020. The second in JAN 2021, 10 days after she broke out in hives and had some angioedema, in lips tingling at times, no throat closures. Eye angioedema was the first sign, around the eyes, that went away and was off and on. On day 10 she woke up with this and has had it ever since. angioedema of the lips on and off. Since Jan 21 she's been headed to toe with hives they never go away, some days her legs are just covered. On 2021, the reporter sated that, 5 days after 2nd vaccine angioedema around both eyes and that was gone now, she's been to dermatologist, immunologist and primary care physician and they've tried, prednisone, IV Benadryl, Zyrtec, Allegra, also done oatmeal baths for itching, dermatologist wanted to put her on cyclosporine, she didn't want to go on it because it's a strong antibiotic. They also gave her pepcid. Reporter asked to have anyone else had anything like this and why it is lasting so long. Reporter stated that everyone was saying, it's an immune response, and give it time and see if it goes away. her daughter woke up in a huge snowstorm the first time she had the angioedema with Mouth, she went to the Emergency Room, they gave her IV Benadryl, kept her there for a little while, sent her home on prednisone pack, not tapered, just 5 days of high dose prednisone. When the prednisone was finished, it came back with a vengeance. Then she went to her Primary Care Physician to see if she had any suggestions. They wanted her to go back on the Prednisone but on a tapered dose, but, she didn't' want to take it because she was afraid it would come back worse than ever. It never got better, not even on the high dose prednisone. Other than put her on the prednisone, there wasn't really anything more. 4 Months later it hasn't settled down. Reporter asked her daughter to come to where she lives and see Dermatologist, and he ordered a bunch of labs and got it back and it all looked fine. He wanted to start her on cyclosporine, she wanted to wait, didn't want to take it. Reporter stated, "It wipes the immune system out. They give it to transplant patients. they all say It's an immune response, it should settle down. Her daughter has been trying to change her diet, eating things low in histamines, cut out tomatoes, cut out cheeses, everything high in histamines, it doesn't make a difference. Reporter stated, One day they are not quite so bad and then she wake's up and she was covered. Her daughter can't walk, or swim cause hot and cold makes her break out, or makes it worse, because it never goes away. The following adverse reactions have been identified during post authorization use of Pfizer BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema). The outcome of the events was reported as unknown. No follow up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1320381
Sex: F
Age:
State: WI

Vax Date: 04/29/2021
Onset Date: 05/03/2021
Rec V Date: 05/15/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Patient was hospitalized for an episode of A-fib; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via intramuscularly, in Arm Left, on 29Apr2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included that she was diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lurasidone hydrochloride (LATUDA), Metoprolol, Lorazepam, rivaroxaban (XARELTO), Quetiapine, Bupropion, Oxybutynin, Atorvastatin, Diltiazem, Losartan, Gabapentin and Furosemide. Since the vaccination, the patient was not tested for COVID-19. It was reported that on 03May2021, the patient was hospitalized for an episode of A-fib which resulted in emergency room/department or urgent care. The patient was hospitalized due to the event from an unspecified date in May2021 to an unspecified date in May2021. Device date was reported as 11May2021. Outcome of the event was recovered with sequel. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event atrial fibrillation and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: LATUDA; METOPROLOL; LORAZEPAM; XARELTO; QUETIAPINE; BUPROPION; OXYBUTYNIN; ATORVASTATIN; DILTIAZEM; LOSARTAN; GABAPENTIN; FUROSEMIDE

Current Illness:

ID: 1320384
Sex: U
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 05/15/2021
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: a 11 year and 5 month old patient who was supposed to receive Tdap but was given Daptacel instead with no reported adverse event; a 11 year and 5 month old patient a dose of Daptacel with no reported adverse event; The patient already had 5 previous doses DAPTACEL and received sixth dose of DAPTACEL instead of Tdap with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00588679) and transmitted to Sanofi on 05-May-2021. This case involves experienced a 11 year and 5 month old patient (gender unspecified) who was supposed to receive DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [Tdap] [lot number, expiry date and other dosing details were not applicable] but was received sixth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] [lot number, expiry date and other dosing details were not reported] instead (wrong product administered, product administered to patient of inappropriate age and extra dose administered). Medical history, medical treatment, family history and concomitant medication were not reported. It was reported that, the patient already had 5 previous doses of Daptacel vaccine. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and extra dose administered. (latency: same day) At the time of report, no adverse event was reported. At the time of report, reporter would like to know about any safety information and any long-term effect information. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1320386
Sex: F
Age: 20
State: CA

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 05/15/2021
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: nurse asks if expired Menactra dose that she administered needs to be repeated with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from other health professional via Medical Information (GMI) (Reference number- 00594513) and transmitted to Sanofi on 10-May-2021. This case involves a 20-year old female patient for whom nurse asked if expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] dose that she administered needs to be repeated (expired product administered) on 06-May-2021 (lot number: U6576AA and expiration date: 04-Apr-2021] at an 0.5 ml once dose via intramuscular route in the left deltoid for prophylactic vaccination. Medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination was not reported, and concomitant vaccination included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]). It was an actual medication error due to expired vaccine used (latency: same day). At the time of report, no adverse event was reported. It was not reported if the patient received a corrective treatment. Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: FLUZONE [INFLUENZA VACCINE]

Current Illness:

ID: 1320396
Sex: F
Age: 49
State: MI

Vax Date: 05/07/2021
Onset Date: 05/08/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium

Other Meds:

Current Illness:

ID: 1320397
Sex: M
Age: 39
State: IN

Vax Date: 05/13/2021
Onset Date: 05/14/2021
Rec V Date: 05/15/2021
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: Chills, tiredness and achy muscles

Other Meds:

Current Illness:

ID: 1320398
Sex: F
Age: 45
State: NJ

Vax Date: 04/19/2021
Onset Date: 04/19/2021
Rec V Date: 05/15/2021
Hospital:

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

Lab Data:

Allergies: None

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

Symptoms: I have noticed a change in my menstrual cycle for 2 cycles post the vaccine 1st and 2nd docse The 2 cycles have had reduced flows, a reduction of approximately 50%. I will continue to monitor if the change persists.

Other Meds: None

Current Illness: Irritable Bowel Syndrome

ID: 1320399
Sex: F
Age: 26
State: GA

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/15/2021
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: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: dizziness-Medium, Additional Details: patient was taken to the er after receiving the epipen. She was monitored for a couple of hours and released. I spoke with husband, when they were home, and was informed that she was feeling well.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm