VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1518000
Sex: F
Age:
State: NJ

Vax Date: 07/08/2021
Onset Date: 07/09/2021
Rec V Date: 07/31/2021
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: couldn't open her eyes; itching/her wrists and the inside of her elbows were itchy and the same thing; facial swelling; hives; swollen/swollen neck; beet red" face/face was completely beet red; rapid heart rate/her heart was beating quite fast; vomiting/she threw up; and her neck looked like the hunchback of (place name); sore arm; sore back; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jul2021 (at the age of 56 years old) (Batch/Lot Number: EW0181) as single dose for COVID-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient inquired about additional information regarding the ingredients of the Pfizer Covid-19 vaccine. She received her first dose of the Pfizer Covid-19 vaccine on 08Jul2021 and reported that the Friday (09Jul2021) following receipt of the vaccine, she experienced a sore arm and sore back. She reports the Saturday (10Jul2021) following receipt of the vaccine, she experienced swollen, beet red face, hives, rapid heart rate, vomiting, and a swollen neck that her husband described as "the hunch back. She reported that taking 2 Benadryl (gel caps 25 mg per capsule, taking 2 every 4 hours) (LOT: 1807907 and Expiry date: Oct2022) and felt better, but upon waking up Sunday (11Jul2021) she felt the same as she did the day before with swelling, hives, itching. She reported that going to the urgent care and was taking Prednisone and continued taking Benadryl and felt good with no issues up until yesterday (18Jul2021) morning when she experienced facial swelling and couldn't open her eyes. She states she heard from one of the urgent care nurses that people who have reactions to shellfish sometimes experience certain symptoms after receiving the Pfizer Covid-19 vaccine. She stated that she realized that it was a rumor, but she has an allergy to shellfish, and she stays away from iodine. The patient asked if there is shellfish or iodine in the vaccine. Reporter confirms her arm being sore and back being sore ended 11Jul2021. Reporter asked since if she should not take the second, since she had a reaction to the first shot and asked for to suggest what to do if she haven't been fully vaccinated. On Saturday, 10Jul2021 she she woke up about 08:00 in the morning and she went into the bathroom and her face was completely beet red, her heart was beating quite fast, she had hives all over her body, she threw up, and her face was completely swollen, and her neck looked like the hunchback. Reporter stated that she took two Benadryl, she went to sleep for a couple of hours, she took two more Benadryl, and she was fine the rest of the day. On 11Jul2021, in the morning, her wrists and the inside of her elbows were itchy and the same thing, she was completely swollen up on her face and had hives, they were just as bad as the day before. Reporter states she took two Benadryl and waited some, she took two more Benadryl, and she went to urgent care. Reporter stated that they saw it was a reaction, they gave her 60 mg of Prednisone and then prescribed her 40 mg Pepcid and 40 mg of Prednisone for 5 days and to continue with the Benadryl every 6 hours. Reporter stated that she did that and everything was back to normal. Reporter stated that the last dose of everything was on this Friday. Reporter stated that on Sunday 18Jul2021, she woke up and her face was completely swollen up again, she couldn't even open her eyes. Reporter states she had no hives, no heart palpitations. Reporter stated that she took two Benadryl and took it easy for a little while then took two more Benadryl and it went down to about a third and then she ran out of Benadryl. Reporter states when she went to the urgent care, the nurse told her that Zyrtec or Claritin might even work better than Benadryl, so she took some Zyrtec and then got really tired. Reporter stated she woke up this morning and her face was still swollen, just as swollen as yesterday, but it is half as better as yesterday, she's still swollen on the top of her lids and the bottom of her lids, but no hives, no other swelling anymore and she hasn't taken Benadryl. Reporter states that she took Zyrtec about 21:00 last night. Reporter states she was against getting the shot because of everything people don't know about it but she's a cashier at a grocery store and they still want people to wear masks. Reporter states something in the back of her head said something was going to go wrong and it did. Reporter stated that her experience on Saturday, 10Jul2021, all symptoms actually all went away by Saturday at 17:00 in the afternoon after taking Benadryl, all her symptoms were gone. Reporter stated her neck wasn't puffed up like it was Saturday either, just had hives, swelling and her heart beating fast too. Reporter states no throwing up, no hunch back, that was just Saturday. Reporter confirmed her face being beet red, neck looking like the hunchback, and her throwing up she recovered completely from on 10Jul2021. Reporter stated all symptoms reported on Sunday, 11Jul2021, subsided on Sunday, 11Jul2021, after she got the 60 mg of Prednisone and Reporter confirms she recovered completely from everything except the swelling face. On Monday, 12Jul2021, she did call out of work because her face was still a little bit swollen. Reporter states she didn't go to work on Monday, but by late Monday, everything was fine when she was taking the Prednisone and Pepcid. Reporter states she was fine Tuesday, Wednesday, Thursday, Friday, and Saturday. Reporter stated that she woke up yesterday, 18Jul2021, and her face was completely swollen again, it's the only symptom she still has. Reporter stated it was ongoing and it was improved. Additional vaccines were not administered on Same Date of the Pfizer Suspect. The adverse events did not require a visit to Emergency Room but went to urgent care. Reporter states it was a Sunday and her primary doctor was closed. No prior Vaccinations were received within 4 weeks of vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events beet red face/face was completely beet red, vomiting/she threw up, her neck looked like the hunchback was recovered on 10Jul2021, Hives, sore arm, sore back, swollen/swollen neck, rapid heart rate/her heart was beating quite fast, itching/her wrists and the inside of her elbows were itchy and the same thing recovered on 11Jul2021, facial swelling was recovering, and unknown for couldn't open her eyes. Description of complaint: Reporter reporting adverse event regarding the Pfizer Covid 19 Vaccine. Reporter reports taking two Benadryl then waiting a little bit and taking two more Benadryl before she visited an urgent care. Benadryl: gel caps 25 mg per capsule, taking 2 pills every 4 hours. Reporter states it's called Benadryl allergy. LOT: 1807907 NDC: 50580-228-24 Expiry Date: Oct2022.

Other Meds:

Current Illness:

ID: 1518001
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: She had the virus (was hospitalized and released after the treatment and receiving the antibodies); She had the virus (was hospitalized and released after the treatment and receiving the antibodies); This is a spontaneous report from a non-contactable consumer. A 95-years-old (95 and a half years) female patient (Mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the virus (was hospitalized and released after the treatment and receiving the antibodies) (Hospitalized, Medically Significant). She was told she needs the covid vaccine. Reporter stated his mother received the first dose of the Pfizer Covid vaccine after some time from getting the antibodies. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518002
Sex: F
Age:
State: CA

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 07/31/2021
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: Passing extremely large clumps/clots of blood multiple times per day.; Excessive menstrual bleeding for nearly 30 days post second vaccination shot/ Bleeding is ongoing; first dose 24May2021 and second dose 24May2021; first dose 24May2021 and second dose 24May2021; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 24May2021 14:15 (at the age of 14-year-old) as dose 2, single; dose 1 via an unspecified route of administration, administered in arm left on 24May2021 14:15 (Batch/Lot Number: EW0173) as dose 1, single, both doses for COVID-19 immunization. Medical history included allergy to peanuts, hazelnuts, soy, almonds, coconut. No concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced passing extremely large clumps/clots of blood multiple times per day, excessive menstrual bleeding for nearly 30 days post second vaccination shot/ bleeding was ongoing on 23Jun2021. Clinical course: Excessive menstrual bleeding for nearly 30 days post second vaccination shot, currently passing extremely large clumps/clots of blood multiple times per day. Bleeding was ongoing since 23Jun2021. The patient received hormones to stop bleeding as a treatment medication for the events. The reporter assessed the events as non-serious. Outcome of the events was not recovered and outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 1518003
Sex: F
Age:
State: AZ

Vax Date: 02/28/2021
Onset Date:
Rec V Date: 07/31/2021
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: it caused an autoimmune disorder to flare up; it caused an autoimmune disorder to flare up; she had a fever; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller states that she had a fever when she wanted to get second dose, so put it off. Her rheumatologist didn't think it was a good idea to get the second dose, and caller thinks it might put her in the hospital. She is also worried, however, about getting COVID and particularly the Delta variant. Caller said she got 1st dose of the Pfizer BIONTECH Covid-19 vaccine on 28Feb2021, and it caused an autoimmune disorder to flare up. She wants to know if she should get the 2nd dose after that happened. Caller took the first dose of the Pfizer COVID 19 Vaccine and was having auto immune flare ups. Caller wants to know if she can and should get the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518005
Sex: F
Age:
State: CO

Vax Date: 01/29/2021
Onset Date: 02/10/2021
Rec V Date: 07/31/2021
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: painful rash/welts randomly on some parts of her body, noting her hands, face and all over her body/parts of her body that were affected: arms, back, chest, face, cheeks, chin, neck and forehead; painful rash/welts randomly on some parts of her body, noting her hands, face and all over her body/parts of her body that were affected: arms, back, chest, face, cheeks, chin, neck and forehead; feel tingly then the welts start about 10 minutes later; her eyes are painful when looking down and up; feeling like the nerves are strained; her eyes get red and irritated and bloodshot; her eyes get red and irritated and bloodshot; her face is deformed; hands are painful and she is unable to lift or turn anyone at work because of her hands hurting/make it hard to use her hands, palms and fingers/hands are painful; Caller stated she had covid skin; hands are painful and she is unable to lift or turn anyone at work because of her hands hurting/make it hard to use her hands, palms and fingers/hands are painful; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on 29Jan2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On 10Feb2021, she started having a rash and welts on some parts of her body and they were on random parts of her body and the welts come and go. I was reported that it was painful welts that affect her arms, back, chest, legs, face, cheeks, chin, neck and forehead. They were like big mosquito bites and were sometimes itchy but not much and were also painful. The area feels tingly and the welts start about 10 minutes later. It quiets down for a day or two then comes back. It was stated her eyes were painful when looking down and up, and feel strained and the nerves feel strained. Her eyes get red and irritated and blood shot. It was reported that ones on her palms and fingers make it hard to use her hands. The patient took prednisone 5 mg and it did not work and took prednisone 20 mg which helped for a short while, but it caused her blood pressure and blood sugar to go up. The patient saw a dermatologist that prescribed a cream and two allergy medications. But nothing was helping. The patient rested for a while thinking that would help but that did not help. Patient used skin sensitive detergent to help. Patient cut off this and that to see what she was allergic to. The patient stated it bothers her working because her hands were painful and she was unable to lift or turn anyone at work because of her hands hurting and her face was deformed and people look at her weird. Rash/welts repeats again and again. Patient stated that it started in the state (name withheld) and continued when she went to another state (name withheld) and Europe. Patient wanted to know what she can do and said she was paying out of pocket. It was also reported that she did not have any allergies before the vaccine and stated it is not due to pollen, trees or flowers. Patient stated she had COVID skin. The outcome for the events was not recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1518006
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 07/17/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Breakthrough Covid-19 diagnosis.; Breakthrough Covid-19 diagnosis.; This is a spontaneous report from a contactable consumer or other non hcp. A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 (at the age of 40-years) as dose number unknown, single for covid-19 immunisation. She was no pregnant. The patient medical history was not reported. The patient's concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. On 17Jul2021, the patient experienced breakthrough covid-19 diagnosis. She had taken doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid test: positive on 18Jul2021. Treatment for event was Unknown. The outcome of the event breakthrough covid-19 diagnosis was recovering.

Other Meds:

Current Illness:

ID: 1518009
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: Rheumatoid arthritis flare up; slight inflammation; Fatigue; This is a solicited report based on the information received by Pfizer. (Manufacturer control number: 21K-163-3986159-00). A contactable consumer (patient) reported that a 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via intramuscular on an unspecified date (Batch/Lot number was not reported), as single dose for Covid-19 vaccination; upadacitinib (RINVOQ), orally from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for Moderate to severe Rheumatoid arthritis. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on an unspecified date as single dose for Covid-19 vaccination. Medical history included ongoing Moderate to severe Rheumatoid arthritis. The patient's concomitant medications were not reported. Solicited report by a consumer of an adult female with events of non-serious fatigue and rheumatoid arthritis flare up with RINVOQ (UPADACITINIB). On unknown date, patient received 1st dose Covid-19 vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose Covid-19 vaccine manufactured by Pfizer. On unknown dates, the patient experienced Fatigue and Rheumatoid arthritis flare up. PFIZER BIONTECH COVID-19 VACCINE was also considered suspect. The patient had slight inflammation. She had Covid-19 vaccine Pfizer brand. She had a reaction on second dose of fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was dose not changed. The outcome of the event fatigue and slight inflammation was unknown, of the event Rheumatoid arthritis flare up was Not recovered. The reporter's causality for the events of fatigue with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's causality for the events of Rheumatoid arthritis flare up with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event Rheumatoid arthritis (Rheumatoid arthritis flare up) and the suspect drug BNT162B2 cannot be completely excluded. 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: RINVOQ

Current Illness: Rheumatoid arthritis

ID: 1518010
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: Doctors suspect aTTP; platelets were very low so they gave her a transfusion.; Fatigue; Headaches; Numbness; Weakness; Speech began to get slurred; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old female patient received bnt162b2 (BNT162B2) dose number unknown , via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced doctors suspect a TTP (thrombotic thrombocytopenic purpura) (medically significant) on an unspecified date with outcome of unknown , platelets were very low so they gave her a transfusion. (medically significant) on an unspecified date with outcome of unknown , fatigue (non-serious) on an unspecified date with outcome of unknown , headaches (non-serious) on an unspecified date with outcome of unknown , numbness (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , speech began to get slurred (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included platelet count decreased: very low . Therapeutic measures were taken as a result of platelets were very low and included a transfusion. Doctors suspect a TTP and she had the Pfizer vaccine so they suspect the two could be linked. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518011
Sex: M
Age:
State: AK

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Three ICD/Defibrilator surgeries later and shifting diagnosis from AVRC to Cardiac Sarcoiditis.; Three ICD/Defibrilator surgeries later and shifting diagnosis from AVRC to Cardiac Sarcoiditis.; March 8th or 9th had episode of heart fluttering that lasted about 1 minute; faint; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Mar2021 at 15:00 (at the age of 39-year-old), as dose 1, single in left arm for COVID-19 immunisation at Pharmacy or Drug Store. The patient's medical history included hypertension. Concomitant medications in 2 weeks included lisinopril, hydrochlorothiazide and simvastatin; all taken for unspecified indications, start and stop dates were not reported. Patient had no known allergies. The patient was not diagnosed with COVID, prior to the vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks after COVID vaccine. On 08Mar2021 or 09Mar2021, the patient experienced episode of heart fluttering that lasted about 1 minute. Was fainted, sat down, and went back to normal. On 15Mar2021 at 11:30, he went into sustained VTAC of 223 and was in VTAC for an hour. ER revived rhythm. Patient had three ICD/Defibrillator surgeries later and shifting diagnosis from AVRC to cardiac sarcoiditis. Any uncertainty on sarcoiditis leads to a vaccine driven event or awakening of a past virus or harm. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized for 4 days due to the events. The events were considered as life threatening illness (immediate risk of death from the event), with disability or permanent damage. Therapeutic measures were taken for events which included ICD Implantation and then a cardiac CRT implant. The clinical outcome of the event heart fluttering was resolved on an unspecified date in Mar2021 and the clinical outcome of all other events was not resolved. Information on the lot/batch number has been requested.

Other Meds: LISINOPRIL; HYDROCHLOROTHIAZIDE; SIMVASTATIN

Current Illness:

ID: 1518012
Sex: F
Age:
State: CA

Vax Date: 03/05/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: diagnosed with the Delta variant; diagnosed with the Delta variant; Fever; severe muscle fatigue; vertigo; severe dizziness; congestion; This is a spontaneous report received from a contactable consumer or other non hcp. A 54-years-old female patient received bnt162b2 (Pfizer COVID-19 vaccine, Batch/Lot Number: EN6206) dose 2, via an unspecified route of administration, administered in Arm Left on 05Mar2021 around 08:30 to 09:00AM as single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. Patient previously took bnt162b2 (Pfizer COVID-19 vaccine, Batch/Lot Number: EN6206) dose 1, via an unspecified route of administration, administered in Arm Left on 12Feb2021 around 08:30 to 09:00AM. The patient was diagnosed with the delta variant of covid-19 on 16Jul2021, severe dizziness, congestion on Jul2021, fever on 13Jul2021, severe muscle fatigue and vertigo on Jul2021. The patient underwent lab tests and procedures which included blood pressure measurement: 125/82 , body temperature: 101 Fahrenheit on 13Jul2021, body temperature: 101 Fahrenheit on 14Jul2021 and sars-cov-2 test: positive on 16Jul2021 positive result for the Delta variant. Therapeutic measures were taken as a result of diagnosed with the delta variant (covid-19), severe dizziness, congestion, fever, severe muscle fatigue and vertigo. The outcome of event fever was recovered while other event outcome was unknown. Consumer was calling about the Pfizer COVID-19 vaccine and said she had taken both doses of the vaccination, with the first being on 12Feb2021 and the second on 05Mar2021. Patient said she had the LOTs for these to provide. She would like to report breakthrough, she had been diagnosed with the Delta variant with a PCR test. She was sick, and is still sick, for six days, and the 13th was when she had her first symptoms. Patient said that the PCR results came back 16Jul after she was tested on the 15th and they confirmed Delta variant. No further details about her friend's friend provided. Pfizer COVID-19 vaccine NDC/EXP: Caller said that these details were not provided on her handwritten vaccine card. Patient said both doses had been given in her left arm she guesses, and they were given in the morning, she is not sure what time, around 08:30 to 09:00AM. She says her appointments were set for 08:45AM. Caller informs that she was not hospitalized for the COVID-19 delta variant symptoms, Patient had fever, muscle fatigue, and congestion. she had pretty severe vertigo to the point she was grabbing walls at times, and she is still really dizzy like if she stands up and turns her head, which is not normally something that she would have. Patient fever was 101 degrees Fahrenheit on 13Jul and 14th, and her fever broke the afternoon of the 14th. For AE treatment LOT is tiny: Nyquil: UPC: 2390001424, LOT: 0154171931, EXP: May2023. Caller says she has been taking this once a day by mouth at night. Caller asks if this is an old Wyeth product, she doesn't know, then says it is manufactured by Pfizer. UPC: 0573016949, LOT: R90265, EXP: August 2023. Caller said she has been taking two PRN, clarified to being two Liquigels by mouth as needed. Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518013
Sex: M
Age:
State: TX

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 07/31/2021
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: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable physician received via Pfizer-sponsored program COVAX Support. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient tested positive for COVID. The event tested positive for covid assessed as serious (medically significant). Caller stated, the patient was basically saying he was having COVID symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller states she knows the symptoms were still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July2021 in the last week and was persisting. Caller states it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of DI ,Covid 19 and suspect drug BNT162B2 cannot be excluded

Other Meds:

Current Illness:

ID: 1518014
Sex: F
Age:
State: IN

Vax Date: 02/23/2021
Onset Date: 02/01/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: the healthcare provider placed it in her shoulder rather than her arm; it hits that shoulder and upper arm and the pain isn't going away; it hits that shoulder and upper arm and the pain isn't going away; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 23Feb2021 between 10:30-11:30am (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Vaccination Facility Type Clinic. Vaccine Administered at Facility: No. Medical history included ongoing shaking. Concomitant medication included primidone 250 mg three times a day (expiry date:13Jan2022), taken for an unspecified indication from an unspecified start date and ongoing; spironolactone taken for an unspecified indication, start and stop date were not reported. AE(s) following prior vaccinations: None. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient got her 2nd dose of the Covid vaccine 23Feb2021 and the healthcare provider placed it in her shoulder rather than her arm. Stated she had had pain there since then and her doctor injected her with something to assist with that and the pain has decreased. Stated she still felt it if there was pressure in the area or anything like that, she had shoulder pain and she put it in her upper arm but her doctor sent her to an orthopedic doctor who said what she did was she hit a nerve, so since 23Feb2021 she had pain and just figured it would go away but she was still having the pain, they did an MRI which cost her and they gave her a shot in her shoulder where they numb it and a pain shot to do away with it and a 2nd numbing shot, sometimes they sent her for therapy and she took a couple of those and learned what to do and does the therapy at home now, she went to sleep on her right side and invariably will turn over and get on her left side and it hits that shoulder and upper arm and the pain isn't going away, she could not afford to keep going to the doctor because between the shot and MRI it's cost her nearly dollar500 and being on social security she lives with the pain. Reporter Details: Caller stated when she was 15 years old she worked in a nursing home under age. Caller stated the shoulder pain started hurting that day and she went to see her doctor first in Mar2021 and he gave her a few pain pills for it, they helped but she was not the type of person that wanted to take pain pills all the time as they make you sleepy and she won't drive when she's taken them so she usually suffers with it, that nothing she was done had really helped that sometimes it will ease up but when she gets up in the morning in the morning time that's when it's the worst until evening. States she doesn't know if therapy is helping a tiny bit, she doesn't have the pain 24/7 she probably has it about 8-10 hours a day. States those are miserable hours because when it first started bothering her if she had her arm out to the side and she wanted to lift it up to the side there where the shot was seemed like it spread into her shoulder and bothers her and she can't lift her arm out from her hip about 3 inches and now she can lift it higher, probably can get it 8-10 inches. States the pain is a hair better, when it first hit her it was horrible and now it's tolerable, it's painful. States she is hoping this is something she doesn't have to live with. Concomitant Medications: Caller stated her regular medicine for shaking, Primidone 250mg 3 times a day, it was supposed to help the shaking and did not from a car wreck, a teenager in high school was driving under the influence back in 1987 and she had the right to take a left and he ran a stop sign and came on top of her car. Caller states she started taking this years ago. Caller does not have NDC or lot to provide. Expiry date 13Jan2022. Caller states she won't have brain surgery at her age as her blood pressure goes up too high. Caller states she also takes Spironolactone. No further details provided. Caller stated she could not keep going to the orthopedic doctor as she can't afford the copay from her insurance. States she is still paying 1 bill and is the reason she stopped therapy and is doing what they showed her at home. Investigations: stated she thought she had the MRI around 9May2021 or 11May2021 or 9Jun2021 or 11Jun2021, she thought it was Jun2021. Stated they just gave her a shot in her shoulder between her arm and her shoulder blade. Caller stated with the 2nd shot when she gave it it hurt like the dickens and kept getting worse and she finally called her doctor and she can't remember if she saw him or (Withheld) the NP but they called in a prescription for pain called Tramadol 50mg and she doesn't like taking stuff like that is she is going to drive anywhere she refuses to take it. Caller states she got stung by a yellow jacket or hornet when she was grilling for her and her husband when he was alive and they were younger and she wondered how a cockle burr got up her nightgown and it stung her and she told NP she is allergic to hornets and yellow jackets, not breathing problems yet but it makes her deathly sick to her stomach. Stated she has no hard feelings or anything. Stated she gets tired of her shoulder and arm hurting other than that give her the pain in her shoulder and arm what's hard is trying to pick something up with her left arm that pain bothers her then. States it's better since the shot in the shoulder hurt like the dickens and it could have been a whole lot worse, there are people that have it a whole lot worse. States she is 70 and on the tail end of her life and that doesn't bother her, she has been to heaven before with that car wreck and she has 1 more fur baby left, all the others have passed on. She prays to God that she's got to raise her black cat and has to be alive until she's gone and then He can have her. The events resulted in physician office visit. The patient underwent lab test and procedure which included MRI on an unknown date in Jun2021 with result unknown. The outcome of the events was unknown. Information about lot/ batch number has been requested.

Other Meds: PRIMIDONE; SPIRONOLACTONE

Current Illness: Shaking

ID: 1518015
Sex: F
Age:
State: NJ

Vax Date: 04/10/2021
Onset Date: 04/01/2021
Rec V Date: 07/31/2021
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: When she saw her sister on 30Apr2021 to celebrate her sister's birthday, her sister had 2 black-eyes from the fall; my sister couldn't breathe; Her sister took her dog for a walk and fell; had "jelly legs," and couldn't walk very well; had "jelly legs," and couldn't walk very well; This is a spontaneous report from a contactable nurse. This nurse reported for a 47-year-old female patient (sister) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8737 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 10Apr2021 at 16:00 PM (age at vaccination: 46 years), as a single dose for COVID-19 immunization. The patient's medical history included had bipolar disorder for at least 15 years, if not longer. The patient had bouts of depression before finally being diagnosed with bipolar disorder. The patient took a cocktail of medications that work for her and keep her very steady. The patient sees a doctor every 3 months for her bipolar disorder. No further details provided. Concomitant medications were not reported. Caller was a registered nurse calling on behalf of her sister. Caller was inquiring about additional information regarding Guillain-Barre syndrome in people who have received the Pfizer Covid-19 vaccine. Caller reports her sister received both doses of the Pfizer Covid-19 vaccine with her second dose being 01May2021. Caller reported her sister has since experience trouble walking and they were awaiting results of a possible Guillain-Barre diagnosis. Caller stated she was having a hard time getting someone to see her sister. Caller asked "what were other people doing in this situation and should I take her back to the ER, could be a medical emergency". Caller reported that her sister has a neurology appointment 13Aug2021 and she has called them multiple times to be seen sooner, but they won't. Caller reported one doctor sent her for a muscle biopsy saying she had myasthenia gravis, but another doctor said it could be Guillain-Barre syndrome from the Covid shot. Caller stated, "I have to go on vacation with my daughter and my husband in the meantime and I'm scared to leave her alone with just my mom". Caller asked "what should we do and was there a team of doctors you could put us in touch with or someone you could call. Caller stated, "my mom didn't go to church yesterday because my sister couldn't breathe". Caller tearfully stated, "I don't know if she'll come back from this". Caller reported on her sister who had both doses of the COVID-19 Vaccine. After her sister went for the first COVID-19 Vaccine dose, her sister had "jelly legs," and couldn't walk very well on an unspecified date in Apr2021. Her sister took her dog for a walk and fell. She remembered her sister fell on Sunday, 25Apr2021, while her sister was walking her dog. Her sister fell on her face, and knees. When she saw her sister on 30Apr2021 to celebrate her sister's birthday, her sister had 2 black-eyes from the fall. Caller reported her sister's neighbours helped her up and grabbed her sister's dog. Her sister said she went in her house and cleaned herself up. Her sister didn't think she broke anything. No further details provided. The patient did not received any treatment for the events. Outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between fall,gait inability,limb discomfort and suspect product BNT162B2 cannot be excluded. 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: 1518016
Sex: F
Age:
State: NY

Vax Date: 02/23/2021
Onset Date: 07/14/2021
Rec V Date: 07/31/2021
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: achy; tested positive for the Coronavirus after receiving the Covid 19 vaccine; tested positive for the Coronavirus after receiving the Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: EL9264; Expiration Date: 31May2021) as single dose, both at the age of 31-year-old for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination) was none. Predisposing factor included Contact with infected person (She was in contact with the person who had the Coronavirus on 11Jul2021). There were no concomitant medications. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not have any AE(s) following prior vaccinations. The patient reported that she and some friends got the Coronavirus after being exposed to it and she and her friends all had received the Covid 19 vaccine. She reports 4 people who were together for a couple hours. She was in contact with the person who had the Coronavirus on 11Jul2021. She tested positive for the Coronavirus on 14Jul2021. She reported being achy on an unspecified date. The AE(s) did not require a visit to Emergency Room or Doctor's office. Outcome of the events was unknown. Summary and Conclusion of product quality Investigation of lot EN5318: The initial scope of the investigation was limited to the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer (city) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There was no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the (city) site. The complaint for lack of effect of the Pfizer-biontech Covid-19 vaccine injectable lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Summary and Conclusion of product quality Investigation of lot EL9264: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (city) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. During formulation of PBS Buffer, there was an undercharge of disodium hydrogen phosphate dihydrate, but this was found to have no impact on product quality. All other raw materials used in the complaint batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9264 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518017
Sex: F
Age:
State: TX

Vax Date: 05/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
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: tested positive for Covid; feeling the initial COVID symptoms; nasal congestion; runny nose; fatigue; This is a spontaneous report from regulatory authority. A contactable Physician reported for a 45-Year-old female patient that: A 45-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Caller stated that the husband and wife got the vaccine, the second vaccine dose back in May2021, but got COVID this week, over the last week. Caller stated that the patient was basically says she was having Covid symptoms, so like nasal congestion, runny nose, not severe, not shortness of breath or chest pain, just mainly URI symptoms, fatigue, just feeling the initial COVID symptoms, not really severe, but having COVID symptoms. Caller stated that she knows the symptoms are still going on, the exact day she was unsure. Caller confirms all symptoms began sometime in July 2021 and is persisting. Caller stated that it was not serious from a medical standpoint. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518018
Sex: F
Age:
State: CO

Vax Date: 07/15/2021
Onset Date: 07/16/2021
Rec V Date: 07/31/2021
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: also cannot breathe well; snotty nose; tingling all over her body/whole body tingles; This is a spontaneous report from a contactable consumer or other non health care professional. A 15-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at the age of 15-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety: Chronic anxiety (Diagnosed 3-4 months ago). Concomitant medications included fluoxetine indication for chronic anxiety from 15Jul2021. On 16Jul2021, the patient experienced tingling all over her body/whole body tingles. On 17Jul2021, the patient could not breathe well and snotty nose. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: FLUOXETINE

Current Illness:

ID: 1518019
Sex: F
Age:
State: SC

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: her eyes and everything else that swelled up; having a problem talking because her lips are so swollen now; having a problem talking because her lips are so swollen now; Face swelling; This is a spontaneous report from a contactable Nurse (patient). A 75-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 10Mar2021 (at the age of 75-years) as a single dose in the left arm for COVID-19 immunization. The patient medical history included blood pressure high, type II diabetes, high cholesterol was ongoing. The patient concomitant medications included Amlodipine 10mg once a day for Blood pressure high, Lisinopril 10mg once a day for unspecified indication, sitagliptin phosphate (JANUVIA) for unspecified indication from an unknown date and unknown if ongoing. On unspecified date of 2021, the patient experienced face swelling. After she got the shot, her face swelled up. She got the shot in Mar and her face swelled up about a week after that. However, her tongue did not swell up. It was her eyes and everything else that swelled up. Then when she went to get the second shot they did not give it to her. Due to face swelling she was placed on Prednisone therapy. After completing the Prednisone Therapy they would not give the second dose. Since that date each month since getting the first dose her face swells up. Like this morning it started to swell up again. She wonders if she can still get the COVID vaccine, but a different one instead, or does it have to be Pfizer, or can she not take any COVID vaccine. The swelling continues, but she can wear masks and it covers it up. Like cannot see her lip under the masks, but it is swollen. She was having a problem talking because her lips are so swollen now. Each month when the facial swelling begins it last for 2-3 days. The event face swelling was assessed as serious medically significant. The clinical outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event face swelling 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: AMLODIPINE; LISINOPRIL; JANUVIA

Current Illness: Blood pressure high (Verbatim: Blood pressure high); High cholesterol (Verbatim: High cholesterol); Type II diabetes mellitus (Verbatim: Type II diabetes)

ID: 1518020
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 07/31/2021
Hospital: Y

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: I went to sleep mode; I could not move my body; collapsed; I have lost movement in my legs at that point and I have to be in the wheel chair and I have shaken in my body; Burning sensation in my chest; my head feels fuel like it is inflamed and I was wondering; Blood clots; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in APR2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date in April2021, after 4 hours of vaccination the patient went to sleep mode, could not move body, collapsed, have lost movement in legs at that point, have to be in the wheelchair and have shaken in the body, burning sensation in chest; head feels fuel like it is inflamed, was wondering and blood clots. The patient was hospitalized on an unknown date in April2021 for all the events. The patient was admitted in the hospital different weeks at a time for the past two and half months now. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot not be requested.

Other Meds:

Current Illness:

ID: 1518021
Sex: M
Age:
State: CO

Vax Date: 01/31/2021
Onset Date: 02/02/2021
Rec V Date: 07/31/2021
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: I started to have a flare up of my ulcerative colitis; This is a spontaneous report from a contactable pharmacist (Patient). A 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 31Jan2021 13:00 as dose 1, single for COVID-19 immunization. Medical history included colitis ulcerative from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not received 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, patient was not diagnosed with COVID-19. It was reported that on 02Feb2021 06:00, two days after the first dose he started to have a flare up of his ulcerative colitis which he had not had a flare up for over 4 years. This flare lasted almost 3 weeks. It went away by the time he had to do the second dose. Patient had to take mesalamine, high two prednisone, dicyclomine and patient had a very bad time. Patient had to visit emergency room and physician office due to event. Since the vaccination, patient tested for COVID-19. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 01Mar2021 Nasal Swab. The outcome of the event was recovered with sequelae. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on close temporal relationship the causal association of the events ulcerative colitis flare up and blood in my feces with the usage of the vaccine BNT162B2 cannot be excluded. 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: 1518022
Sex: F
Age:
State: CA

Vax Date: 02/19/2021
Onset Date: 02/22/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: experienced lasting effect permanent cognitive/neurological decline after 2nd dose.; experienced lasting effect permanent cognitive/neurological decline after 2nd dose.; short term memory loss.; unable to articulate the language arts side of the brain, even though high professional performer; This is a spontaneous report from a contactable other hcp (patient). A 41-years-old non-pregnant female patient received bnt162b2 (Pfizer, covid 19, formulation: solution for injection, Batch/Lot Number: el9262), via an unspecified route of administration, administered in Arm Left on 19Feb2021 13:45 (at the age of 41-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications ware not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medication in two weeks. The patient previously took bnt162b2 (Pfizer, covid 19, formulation: solution for injection, Batch/Lot Number: el3249), via an unspecified route of administration, administered in Arm Left on 21Jan2021 01:15 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. On 22Feb2021, the patient experienced lasting effect permanent cognitive/neurological decline after 2nd dose, short term memory loss, unable to articulate the language arts side of the brain, even though high professional performer. Therapeutic measures were taken as a result of experienced lasting effect permanent cognitive/neurological decline after 2nd dose. (neuropathy peripheral), experienced lasting effect permanent cognitive/neurological decline after 2nd dose. (cognitive disorder), short term memory loss. (amnesia), unable to articulate the language arts side of the brain, even though high professional performer (language disorder). The clinical outcome of the events was not recovered. Case comment: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between Neuropathy peripheral, cognitive deterioration, amnesia, language disorder and suspect product bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product was 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: 1518023
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/13/2021
Rec V Date: 07/31/2021
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: tested positive for Covid after getting the vaccine; tested positive for Covid after getting the vaccine; This is a spontaneous report from a contactable consumer (friend) reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Jul2021, the patient tested positive for COVID after getting the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 13Jul2021. The event outcome was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518024
Sex: M
Age:
State: NJ

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 07/31/2021
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: Legs, ankles and feet started to swell up; spinning and light headedness did not go away; spinning and light headedness did not go away; The patient was hospitalized and had heart tests done; heart was racing; Extremely tired and could not move; Extremely tired and could not move; Legs, ankles and feet started to swell up; Legs, ankles and feet started to swell up; Lost 15lbs these three months; The biggest thing was the patient had very low iron, very low blood; patient's blood work was completely out of whack; This is a spontaneous report from a contactable consumer. A 65-year-old male patient (husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: not reported), DOSE 2, SINGLE via Arm on 02Apr2021 16:00, as single dose for COVID-19 immunization (Age at vaccination site 65 year). The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: not reported), DOSE 1, SINGLE on an unspecified date at 15:00 in arm, as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. The patient was hospitalized on 14Jul2021 to 16Jul2021. Prior to being hospitalized, two weeks after receiving the second dose Pfizer Covid Vaccine the patient started having a reaction and went to the doctor. The doctor said to give it 4 to 6 weeks. Meanwhile, the patient's heart was racing. The patient was lightheaded. heart was racing: When asked when this began, the consumer stated the second dose Pfizer Covid Vaccine was received on 02Apr2021 and within two weeks after the patient started having symptoms. The symptoms progressively got worse. The patient was extremely tired and could not move. The patient went through all the heart test, an echo, an EKG and come to find out everything was fine with the consumer heart. The patient's legs, ankles, and feet started to swell up. The consumer stated this began after the heart stuff. The patient called the doctor again and was told to cut down on salt if using too much. The patient wasn't really using too much salt but cut the salt out completely. The swelling of the legs, ankles and feet lasted about a week or two. Extremely tired and could not move and spinning and light headedness did not go away. More blood work was done, and the patient blood work was completely out of whack. All the callers can say is they were the main things. The biggest thing was the patient had very low iron, very low blood. A specialist was called in for the liver and kidney function. The specialist said a virus attacked the patient's blood and this is what happened. The patient was given a Procrit shot in the hospital, an IV and heparin. The patient had CAT scans, ran a lot of blood work. Blood work was done every 4, 6 or 8 hours, started at every 4 hours and went to every 8 hours. The consumer stated everything began right after the patient received the second dose Pfizer Covid Vaccine. Consumer clarified, everything began two weeks after the patient received the second dose Pfizer Covid Vaccine. If the consumer gets up a little fast, yes the spinning and light headedness are still ongoing, but nothing like it was. because the patient was given an IV at the hospital. The patient has lost 15lbs these three months. It is not like the patient to lost 15lbs. When asked if this is ongoing or has stopped, the caller replies the patient is holding his own right now. The outcome of event (Dizziness, vertigo) was recovering and (Legs, ankles and feet started to swell up) was recovered in 2021 and event of (Fatigue) was not recovered yet and rest of all events were unknown.

Other Meds:

Current Illness:

ID: 1518025
Sex: F
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patient stated she would slit her wrist if we weren't able to assist her.; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient stated she would slit her wrist if we were not able to assist her. Patient stated she had COVID-19 shots. The outcome of the event was unknown. Information about lot and batch number was requested.

Other Meds:

Current Illness:

ID: 1518026
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: patient is pregnant; tested positive for Covid after getting vaccine; tested positive for Covid after getting vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient was tested positive for Covid on unknown date in Jul2021 after receiving the Pfizer Covid 19 vaccine. Patient was pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on Jul2021. Query was sent to the reporter to ask whether the patient was pregnant before Pfizer COVID Vaccine to which a response was received to clarify that the patient was pregnant, but it was not clarified whether or not the patient received the vaccine while she was pregnant or prior to her pregnancy. Investigation Assessment reported as Yes. There was a Product Complaint. Description of complaint: Caller reporting an adverse event and mentions her friend who tested positive for Covid after receiving the Pfizer Covid 19 vaccine. LOT; NDC; Expiry Date: Not provided. Caller declines to complete report. The outcome for the events was unknown. Information about lot and batch number was requested.

Other Meds:

Current Illness:

ID: 1518027
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: tested positive for COVID after receiving the vaccine; tested positive for COVID after receiving the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for covid after receiving the vaccine on an unspecified date. Caller reported adverse event and mentioned friend who tested positive for Covid after received Covid 19 Vaccine. The reporter was out with friends last Sunday on 11Jul2021, and on Tuesday, 13Jul2021, one of them texted her to let her know that he tested positive for Covid. She did not have all the information. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518028
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: After being infected by my son in law who is also vaccinated with the Pfizer vaccine; After being infected by my son in law who is also vaccinated with the Pfizer vaccine; This is a spontaneous report received from a contactable consumer via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-COVID19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose number unknown,single for covid-19 immunization .The patient medical history and concomitant medications were not reported.The patient got infected with covid-19 after being infected by his son in law who was also vaccinated with the pfizer vaccine on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Wednesday July14.The patient reported that he was fully vaccinated in February.The outcome of the event was unknown. Information on lot /batch number has been requested.

Other Meds:

Current Illness:

ID: 1518029
Sex: M
Age:
State: PA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 07/31/2021
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: This is a spontaneous report from a contactable consumer or other non HCP via clinic. A 81-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: ER8727, Expiration date: unknown), via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received his first vaccine dose on March 19th (Lot ER8727, no expiration date). asking when he was able to get his second vaccine dose or if he needs to repeat the entire series because he had covid. Caller reports that first vaccine dose her husband was diagnosed with Covid through a rapid Covid test at rite aid, stating, suspect he may have already had Covid because he contracted Covid a few days after he got the vaccine. Caller reports that a few days after her husband received the vaccine started feeling sick he wasn't able to notice if or when he had any symptoms. Caller reports that her husband got Monoclonal antibodies and Remdesivir while in the hospital. She reports that the Monoclonal antibody people said wait 90 days to get the vaccine, then our Family doctor wanted him to wait 120 days. Now he (my husband) is nervous and jerky because of the delta strain. Caller states, there was so much conflicting information just want to clarify when he should get the second dose or if he needs to repeat the series. The patient underwent lab tests and procedures which included rapid Covid test unknown result on an unspecified date. The outcome of events was unknown.

Other Meds:

Current Illness:

Date Died:

ID: 1518030
Sex: M
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: sudden death of a 13-year-old (place)child who had a second dose of Pfizer vaccine; This is a spontaneous report from a non-contactable consumer (columnist). A 13-year-old male patient received second dose of BNT162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that remained strangely silent over the sudden death of a 13-year-old child who had a second dose of Pfizer vaccine. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death

Other Meds:

Current Illness:

ID: 1518031
Sex: F
Age:
State: MO

Vax Date: 03/11/2021
Onset Date: 04/21/2021
Rec V Date: 07/31/2021
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: tested positive for covid on 16Jul; tested positive for covid on 16Jul while her husband, 17Jul; she thought she had a sinus infection; having trouble breathing; coughing up of green stuff and worsened coughing; flu/cold; she got real sick; flu/cold; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:45 (at the age of 64-years-old) as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:45 (at the age of 64-years-old) (Batch/Lot Number: ER8734; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. The patient's medical history included obesity. No other medical history reported. There were no concomitant medications and other products reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). There were no predisposing factors (e.g. immunosuppression, contact with other infected persons). The patient and her husband got their first dose of the Pfizer Covid 19 vaccine last 11Mar2021 and their second dose was on 31Mar2021. Caller stated the covid 19 vaccination record. She got real sick, like with a flu/cold and she took some over the counter medicine, pain medicine but caller states on Wednesday, 21Apr2021, she had to go to the emergency room because she was having trouble breathing and has continued coughing up of green stuff and worsened coughing. Albuterol Nebulizer. She has been doing the nebulizer, the albuterol nebulizer machine. Caller states that's only if she's having an attack, but she hasn't had one prior to this. Caller verifies she hasn't had an attack prior to getting the shots. Caller provides Albuterol Nebulizer LOT: 021331, Expiry Date: Apr2022. Caller provides over the counter medicine she was taking: Alka-Seltzer Plus, Severe Cold and Flu. She doesn't have the box anywhere; she usually throws them away. Caller provides with LOT: X24AD9 EXP: Jun2022. Product strength and count size dispensed: Caller states they are 250 mg each tablet, she takes two usually by mouth. She was unsure of the quantity in the package since she threw both away. Albuterol Nebulizer: Not provided. The patient tested and diagnosed with positive for covid on 16Jul2021 while her husband, 17Jul2021. Asked why they got covid since they already got both doses of the vaccine. The patient asked if the vaccine they got was effective. The patient wanted to make sure the vaccine that was given to them is really from Pfizer. No prescribing doctor. On 16Jul2021, she visited physician office: urgent care, as she thought she had a sinus infection. What she is looking for is they both had the vaccine and they are positive with covid. Was this any good, and are there other people who are now positive, were the lot numbers any good. They did what the world said and now they have covid 19 and she was missing 14 days of work. She spoke with Medical information and they can't give any information. She wants to know why they got covid. Is it a hoax and in fourteen she will have been healed and can go back to work. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The result of the assessment concluded there was no microbiological impact to Lot EP8573. The batch remains acceptable for use. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1518032
Sex: M
Age:
State:

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 07/31/2021
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: had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; Feelings of having a fast-beating, fluttering, or pounding heart; his breath sometimes is short, like short in breathe, but not too much; Chest pain; Feelings of having a fast-beating, fluttering, or pounding heart; Feelings of having a fast-beating, fluttering, or pounding heart; This is a spontaneous report from a contactable consumer or other non hcp (Patient). This consumer reported that a 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Age at vaccination 31 years) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : ER8733), via an unknown route of administration on 24Mar2021 (Age at vaccination 31 years) as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better; his breath sometimes is short, like short in breathe, but not too much and chest pain. It was reported that caller states that he got his vaccine 3 months ago, clarified later in the call to the COVID vaccine, he had the 1st dose and then the 2nd dose 2 months ago. After that he had pain in his heart and it comes back and forth, sometimes it is worse and sometimes it is better, and his breath sometimes is short, like short in breath, but not too much. The pain in his heart bothers him. Pain in his heart: He thinks it started like 2 and a half months ago after his 2nd dose. Sometimes it is better and sometimes it is worse, it is back and forth. Short in breath: The short of breath happens not too much, just a few times but right now he doesn't have it. Caller stated that he has experienced the symptoms (Chest pain, Shortness of breath, Feelings of having a fast-beating, fluttering, or pounding heart) and would like to know where he should go to be evaluated and treated. Caller stated after that about two and half months ago he had pain in his heart and occasional shortness of breath. Caller stated that he is still having pain in the heart but no shortness of breath now as it only happened a few times. The clinical outcome of all the events were not resolved while the outcome of the event chest pain was unknown. Investigation Assessment: No Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518033
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: with arm soreness and a bit more tired; with arm soreness and a bit more tired; This is a spontaneous report from a contactable Other-HCP. A 64-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization and received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021(at the age of 64-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Covid vaccine twice on Apr2021 with arm soreness and a bit more tired afterwards but doing ok now. The outcome of the events was resolved on unspecified date in 2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518034
Sex: F
Age:
State:

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

Symptoms: She had to take to the Hospital because she is losing the blood, they told this is internal bleeding, so they gave her the blood transfusion but still losing the blood; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Mother-in-law) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), 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. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Reporter stated, "Why I am calling is that I have few questions about the side effects for the Pfizer Covid-19 vaccine vaccination. It was for my mother-in-law (consumer) after the second dosage vaccination, after one month. On an unspecified date, she had to take to the hospital, and she was losing the blood. I was just asking you was it normal after one month of the second dosage. She was losing the blood, they told this is internal bleeding but she didn't have any internal bleeding, so they gave her the blood transfusion but she was still losing the blood." The patient was hospitalized on an unspecified date. Reporter stated, "I will ask for my mother-in-law if she get more information, I would call because I want to get more information like was it from the vaccination if she gets advice from the Doctor, if they know the procedure to help her." Outcome of the event was not recovered. Information about Lot/ Batch number have been requested.

Other Meds:

Current Illness:

ID: 1518035
Sex: M
Age:
State: MO

Vax Date: 03/31/2021
Onset Date: 07/10/2021
Rec V Date: 07/31/2021
Hospital: Y

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: had Atrial fibrillation 2 1/2 months after getting the second dose of the vaccine; tested positive for covid on 16Jul while her husband, 17Jul; tested positive for covid on 16Jul while her husband, 17Jul; This is a spontaneous report from a Pfizer Sponsored Program a contactable consumer or other non hcp. This consumer reported for a male patient (Husband) that: A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8734, Expiration Date: 31Jul2021) via an unspecified route of administration in left arm on 31Mar2021 09:45 as dose 2, single for COVID-19 immunization (At the age of 63-year-old). The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6207, Expiration Date: Jul2021) via an unspecified route of administration in left arm on 11Mar2021 09:45 as dose 1, single for COVID-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient did not received any prior vaccinations within 4 weeks. The patient experienced had atrial fibrillation 2 1/2 months after getting the second dose of the vaccine on 10Jul2021, tested positive for covid on 16jul while her husband, 17Jul on 17Jul2021, they both received both doses of the pfizer biontech covid vaccine in Mar2021, and now they both have covid on an unspecified date. It was reported that, caller and her husband got their first dose of the Pfizer Covid 19 vaccine last 11Mar2021 and their second dose was on 31Mar2021. Patient was diagnosed with COVID 17Jul2021. Reporter enquired that why they got covid since they already got both doses of the vaccine and asked if the vaccine they got was effective. Patient had had Atrial fibrillation 2 1/2 months after got the second dose of the vaccine and wanted to know if Pfizer shot can cause Atrial fibrillation. The patient he went to the ER with A-fib, was hospitalized for had atrial fibrillation 2 1/2 months after getting the second dose of the vaccine from 10Jun2021 to 13Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17Jul2021. Therapeutic measures were taken as a result of had atrial fibrillation 2 1/2 months after getting the second dose of the vaccine. The outcome of the events was unknown. Lot-# (CR): ER8734 Conclusion of Previously Completed Investigation: Truncated Conclusion -See PR ID of Previously Completed Inv for full text The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lotEP8573. A complaint sample was not returned Lot-# (CR): EN6207 Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Description of complaint: Caller reporting adverse events. Caller states she got real sick, like with a flu/cold and she took some over the counter medicine, pain medicine but caller states on Wednesday, 21Apr2021, she had to go to the emergency room because she was having trouble breathing and has continued coughing up of green stuff and worsened coughing. Albuterol Nebulizer: Caller states she has been doing the nebulizer, the albuterol nebulizer machine. Caller states that's only if she's having an attack, but she hasn't had one prior to this. Caller verifies she hasn't had an attack prior to getting the shots. Caller provides Albuterol Nebulizer LOT: 021331, Expiry Date: Apr2022. Caller unsure of NDC. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518036
Sex: F
Age:
State: ID

Vax Date: 07/06/2021
Onset Date: 07/18/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Spontaneous miscarriage with no previous history of miscarriages.; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 25-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: ewo198) via an unspecified route of administration, administered in arm left on 06Jul2021 at 16:30 pm as dose 1, single dose for covid-19 immunization (at the age of 25-years-old). Medical history included pregnancy from an unknown date. The patient's 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. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. It was reported that on 06Jul2021 the pregnant female patient received first dose of vaccine and on 18Jul2021 at 14:00 pm she had spontaneous miscarriage with no previous history of miscarriages. The mother was 4 weeks pregnant at the onset of the event. The mother was due to deliver on 28Mar2022. Patient had not received any treatment for the event. The outcome of the event was reported as recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518037
Sex: U
Age:
State:

Vax Date: 07/14/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
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: Vomiting; Feeling so sick; I felt a little better maybe it was something like I kind a have burp or something; I slept just about all day to day and ofcourse all day Sunday; it was just awful pain in my belly and heart; Diarrhea; Nauseous; Shortness of breath; Chills; I was just feeling weak and tired like no energy and I am still feeling that; I was just feeling weak and tired like no energy / I feel so tired and just fatigue; Had a sharp pain, it was just constant pain in my stomach almost felt like it could have been food poisoning or something; It was just awful pain in my belly; Had a sharp pain, it was just constant pain in my stomach almost felt like it could have been food poisoning or something; It was just awful pain in my belly; I barely eaten anything on Saturday; My heart was just beating irrationally fast; I couldn't sleep; Moment was so terrifying; I am awake because of the pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EW0167) via unknown route of administration on 14Jul2021 as dose 2 single for Covid-19 immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Lot number: EW0167) on unspecified date in 2021 for Covid-19 immunization. It was reported that consumer stated, "I have been having some different symptoms that I think are related to the vaccine possibly and I received the first one and three weeks later, I received the second one and the second Pfizer vaccine, I received was this past Wednesday on the 14Jul. So, on Saturday, I was having diarrhea, nauseous on 17Jul2021, during the early part of the day, the morning and midday and it continued all in a course but that was when it started on Saturday and then Saturday evening, when I went to get my shower before bedtime around 8:00 PM, I was experiencing shortness of breath on 17Jul2021 after I got the shower and I was just feeling weak and tired like no energy on 17Jul2021 and I am still feeling that. "Consumer further stated, "When I went to go to bed, I guess I lay down at about 10:30 and I had a sharp pain, it was just constant pain in my stomach almost felt like it could have been food poisoning or something but I knew it wasn't that because I hadn't eaten anything bad, I barely eaten anything on Saturday and when I did, it was just that and I stay calm and rest around and I had a few pounds steak and I couldn't even eat maybe even a 'third of it'. So, it was just awful pain in my belly and heart, my heart was just beating irrationally fast all on 17Jul2021. I couldn't sleep and I couldn't know, the way I tossed and turned, it was not comfortable to let me sleep, I don't, it is really, the moment was so terrifying in Jul2021 and I was just glad that part was over" Consumer further stated, "So, by early Sunday morning, I had vomiting on 18Jul2021 and this sharp pain was subsiding but not totally but it wasn't this worse. I couldn't get to sleep, it was probably about maybe I don't know at 11:00 because I woke up vomiting, I couldn't get to sleep on Saturday, late Saturday night, it would be for 20 minutes or 40 minutes something like that and then I am awake, I am awake because of the pain in Jul2021. So, around Sunday morning after the vomiting, I felt a little better maybe it was something like I kind a have burp or something, I was feeling a little better but not totally, still there was some pain there and so, I am just trying to figure out why am I feeling so sick on 18Jul2021, still it I 'went to pull the papers out' and I got to the Pharmacy to read over my papers and see if it was possibly be related to the vaccine and I would be able to know, I honestly don't know but I do see the symptoms like because of tiredness I haven't been able to do anything, like I barely can get to my bathroom and back to my bed, I feel so tired and just fatigue and no energy and also I was experiencing chills on 17Jul2021. So, I slept just about all day to day and of course all day Sunday on 18Jul2021 when I could found I am just 'sleeping over there' and yesterday but half an hour, I was feeling chills and nauseous, I am still feeling nauseous and the diarrhea and vomiting did stop." The outcome of events diarrhoea, vomiting and fear was recovered in 2021, nauseous, shortness of breath, asthenia, tiredness, burping was not recovered, while for others was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1518038
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: hearing loss; tinnitus; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as Dose 2, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at Dose 1,Single for COVID-19 immunization. Patient really felt tinnitus was related to COVID vaccine. It started on an unspecified date about 3 weeks after the second dose. Patient went to ear specialist. She noted patient had mild hearing loss which patient have never had before. She said the tinnitus was related to the loss of hearing. She could not confirm or deny any vaccine cause. She did say she sees hearing loss and tinnitus with the Covid infection. Patient would just like you to add it to our studies. It was not going away. Adverse events resulted into physician's office visit. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1518039
Sex: F
Age:
State: VA

Vax Date: 05/23/2021
Onset Date: 05/24/2021
Rec V Date: 07/31/2021
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: leg swelling; feet and ankles swelled up really big; big red rashes on her legs; pneumonia; blood clot in each leg; Cough and some phlegm and she doesn't feel bad; cough and some phlegm and she doesn't feel bad; fever for a few days; This is a spontaneous report from a contactable Consumer (patient reported for herself) communicated to Pfizer- sponsored program. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0187, expiration date: not reported), via an unspecified route of administration, administered in Arm Left on 23May2021 at 15:00 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. Medical history included covid-19 (positive for SARS-CoV-2) in Dec2020 and had blood clots back in December 2020. AE(s) following prior vaccinations were none. Patient Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was none. The patient concomitant medications were not reported. 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) were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were none. On 24May2021, the patient experienced fever for a few days and experienced pneumonia on 13Jun2021. On an unspecified date in Jun2021, the patient experienced blood clot in each leg, Cough and some phlegm and she does not feel bad. The patient also experienced leg swelling, feet and ankles swelled up really big and big red rashes on her legs on unspecified date inJul2021. The clinical course of the events as follows: Pneumonia; cough; phlegm: patient stated she had pneumonia around 13Jun2021, she still has a cough and some phlegm, and she does not feel bad, it was just annoying. Patient stated the cough and phlegm started at the beginning of Jun2021 and was still ongoing but has improved. The patient stated that she had pneumonia in between, which maybe because of blood clots. Received two more blood clots: patient stated she went to the hematologist and she was on blood thinners for 3 months with her regular physician and she took the caller off blood thinners and then the patient started having symptoms in her leg and swelling, so she was sent back to hospital to get an ultrasound and where they found she had new ones in each leg. She stated that she had a blood clot in January, they said it was from thickening of blood from Covid and then after the vaccine, she received two more blood clots. Patient stated on an unspecified date, this past week she had an episode where her feet and ankles swelled up really big and she had big red rashes up her legs, and it was a mystery. Patient confirmed both began in Jul2021 and the rashes were almost gone, she could slightly see it but the swelling was gone because she had stayed off her feet pretty much. She confirmed that the rashes were ongoing and have improved and swelling had stopped. Patient stated she would say it stopped 18Jul2021 and had recovered completely from the swelling. The events required a visit to emergency room and Physician Office, but no hospitalization. Relevant Tests were none or unknown. she tested positive for Covid last December. She reported missing the second dose because she had pneumonia and was asking to see if she could still get her second dose, or it was too late for her to get the second one. Patient also reported having heard that the first dose of the Pfizer BioNTech COVID-19 vaccine is stronger than the Johnson and Johnson COVID-19 vaccine.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Dec2020, ultrasound scan: found new blood clots in each leg on an unknown date, ultrasound scan: found blood clot on Jun2021. The outcome of the event fever was resolved on 27May2021, leg swelling, and feet and ankles swelled up really big were resolved on 18Jul2021, outcome of the events pneumonia, Cough and some phlegm and she does not feel bad and big red rashes on her legs was resolving at the time of this report. The outcome of the event blood clot in each leg was not resolved at the time of this report. Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518040
Sex: M
Age:
State: MO

Vax Date: 07/17/2021
Onset Date: 07/18/2021
Rec V Date: 07/31/2021
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: Low-grade fever observed on 18JUL2021.; This is a spontaneous report from a contactable Pfizer colleague reported for a 15-year-old male patient that, received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in Arm Left on 17Jul2021 (at the age of 15-year-old) as single dose for covid-19 immunization. There were no concomitant medications. Known allergies and other medical history was reported as no. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Arm Left on 26Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 15-year-old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low-grade fever observed on 18Jul2021. Seriousness was reported as non-serious. Patient did not receive treatment for adverse event. The outcome of the event was resolved on unknown date in Jul2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518041
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date: 06/29/2021
Rec V Date: 07/31/2021
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: diagnosed with a stroke in the retina; In the beginning the patient could only see black but now he can see.; This is a spontaneous report from a contactable consumer or other non-health care professional. A 42-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in May2021 (at the age of 42-year-old) as dose 2, single for covid-19 immunisation. Medical history included problem with the heart valve (diagnosed when the patient was in his 30s) and blood pressure medicine, after his heart operation on an unspecified date. Concomitant medications included blood pressure medicine, after his heart operation. Historical vaccine included as patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 42-year-old) at dose 1, single for covid-19 immunisation and experienced with tired after the first dose, this started a few hours after he got the vaccine and the next day. The patient rested for the day and then was fine. After second dose of Pfizer vaccine, in last week of June on 29Jun2021 patient experienced with stroke in the retina an emboli went into the retina and caused a stroke there. They looked coagulation factors on the patient, he already has pre-existing issues in the heart with one of his valves. On an unspecified date the patient experienced in the beginning the patient could only see black but now he can see. The event diagnosed with a stroke in the retina was reported as serious with seriousness hospitalization. The patient was hospitalized with a stroke in the retina (cerebrovascular accident) from 01Jul2021 to 02Jul2021. The patient was in the hospitalized for 2-3 nights. Reporter spoke with some doctors who have confirmed retina stroke has been reported with covid-19 vaccines. They have seen some cases. Reporter doesn't know if these cases are associated with the Pfizer COVID-19 vaccine or not. Investigation Assessment was provided. Lab tests included with CT scan, an MRI of the brain and everything that needed to be done on HTE patient while in the hospital. Therapeutic measures given as the patient was started on blood thinners. The reporter sent the imaging of the heart and the eye to her colleagues who were retinologist and a cardiologist. Caller was a scientist. The caller's colleagues asked if the patient got the vaccine and he did about 2 months, prior to this event but patient was never sick. Investigation provided as follows: The patient had an imaging done in the hospital. MRI of the brain was clean, a CT of the patient's carotid which was clean, blood tests, imaging of the eye which showed a stroke in the retina, and a TEE of the heart which showed what was happening in the valve. The lipid and coagulation factor were normal on the patient's blood work. Outcome of the events in the beginning the patient could only see black but now he can see was unknown and diagnosed with a stroke in the retina was resolving.

Other Meds:

Current Illness:

ID: 1518042
Sex: F
Age:
State: NC

Vax Date: 06/05/2021
Onset Date: 06/11/2021
Rec V Date: 07/31/2021
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: Extreme pain in lower back; inflammation in lower back; elevated white blood count; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 05Jun2021 02:45 PM (Age at Vaccination: 46 years) as dose 2, single for COVID-19 immunisation. Facility type vaccine was reported as Pharmacy or Drug Store. The patient medical history included Chronic hives and had none known allergies. Covid prior vaccination was reported as none. Other vaccine same date product was reported as None. Other vaccine in four weeks was reported as no. The patient Concomitant medications in two weeks included Fexofinidine . The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on arm left on 18May2021 03:00 PM (at the age of 46 years) as dose 1, single for COVID-19 immunization. On 11Jun2021 03:00 PM, the patient experienced Extreme pain in lower back, inflammation in lower back, elevated white blood count. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid tested post vaccination was reported as no. The lab tests included test: White blood cell count, result: Increased on 11Jun2021. Therapeutic measures were taken as a result of events and treatment included Steroids and antibiotics. The outcome of the events was not recovered. Information about lot/batch has been requested.

Other Meds: FEXOFENADINE

Current Illness:

ID: 1518043
Sex: F
Age:
State: FL

Vax Date: 05/07/2021
Onset Date: 07/05/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: I have bled for 20 days and it is still ongoing; menstrual cycle was delayed a week; high blood pressure; I had a fever; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 11:00 (Batch/Lot Number: EW0153) as DOSE 2, SINGLE for Covid-19 immunisation. Medical history included Temperature intolerance, Vertigo, Heat stroke, Food allergy and Shellfish allergy from an unknown date and unknown if ongoing and included Historical Vaccine BNT162B2 for COVID-19 immunisation as Dose 1 on arm left at 2:30 Pm with Lot number ER2613. The patient's concomitant medications were not reported. The patient experienced I have bled for 20 days and it is still ongoing, Menstrual cycle was delayed a week, High blood pressure and I had a fever on 05Jul2021 12:00. No other vaccine was given in four weeks. There was no treatment received for any of the events. Patient did not have Covid prior vaccination and patient was not tested for Covid 19. The outcome for all the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518044
Sex: M
Age:
State: WI

Vax Date: 05/08/2021
Onset Date: 05/01/2021
Rec V Date: 07/31/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: subsequent heart attack; they were not getting his blood sugar numbers down and they felt something was not right/on 28May2021 blood sugar was very high at 880; left shoulder pain; weakness in the left arm; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (wife) reported for 47-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0176 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08May2021 at 09:00 PM (age at vaccination: 47 years), as a single dose for COVID-19 immunization. The patient's medical history included ongoing diabetes. Concomitant medications were not reported. Caller called on behalf of her husband (patient) that the patient had a subsequent heart attack on an unspecified date in May2021, stent placement and left shoulder pain and weakness in the left arm. Caller wanted recommendations on her husband getting the second dose of the vaccine relative to these events. The patient was in hospital for heart attack from 28May2021 to 04Jun2021. The patient was diagnosed 3-4 years ago but not being treated at time of event. When patient got to hospital on 28May2021 blood sugar was very high at 880. Caller clarified that they believe he had the heart attack at some time between 18:00 on 09May2021 and 04:00 on 10May2021 but they did not know he had the heart attack until hospitalization starting 28May2021. She clarified that she called to ask what the recommendations were regarding him getting the second dose of Pfizer Covid-19 Vaccine relative to these events and how the second dose might affect him. At some point in that time period, he started feeling funny and he drives a forklift, so he pulled over and parked. At 04:00 on 10May2021, he was woken by a coworker who told him he was sleeping and to go home. He was not the same after that. Caller initially reported she believes he has recovered completely other than complaining of left shoulder pain and weakness in his left arm that started date of his stent placement on 30May2021. The patient was admitted to the hospital starting 28May2021 after they talked to a doctor on the phone-initially taken by ambulance to first hospital and then in the middle of the night on 29May2021 was transferred to the ICU department in a different hospital where he remained admitted until discharged against medical advice on 04Jun2021. The reason that he left the hospital against medical advice was because they were having trouble with the doctor who kept coming in to the hospital and saying that the patient could go home then they would come in and say he couldn't go home because the Endocrinologist said he couldn't. That went on for 3 days. At the hospital they were not getting his blood sugar numbers down and they felt something was not right, so they ended up leaving. The patient came home, and they had the ambulance come there to double check him and his blood sugar levels have been perfect while home although he has stress. The event subsequent heart attack was resulted in emergency room visit. Outcome of the events left shoulder pain and weakness in the left arm was not recovered and for all other events, it was unknown.

Other Meds:

Current Illness: Diabetes (Verbatim: Diabetes)

ID: 1518045
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
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: COVID infection after full vaccination. Vaccination in April, infection in July; COVID infection after full vaccination. Vaccination in April, infection in July; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single, both doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced COVID infection after full vaccination. Vaccination in April, infection in July on an unspecified date in Jul2021. Event took place after use of product. The patient underwent lab tests and procedures which included COVID infection was positive on an unspecified date in Jul2021. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518046
Sex: F
Age:
State: GA

Vax Date: 03/16/2021
Onset Date: 03/31/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tingling and numbness sensation; I couldn't feel or move my tongue/ I couldn't move it for about a week; couldn't feel or move my tongue. It seemed swollen and numb; couldn't feel or move my tongue. It seemed swollen and numb; small hole underneath my tongue; had canker sores appear all inside my mouth and the veins underneath my tongue began turning white; had canker sores appear all inside my mouth and the veins underneath my tongue began turning white; My tongue began feel scorched, the sores would appear on my jaw and inside my lip; My tongue began feel scorched, the sores would appear on my jaw and inside my lip; This is a spontaneous report from a contactable consumer, the patient. A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 16Mar2021 at 16:30 (at the age of 38-years-old) as dose 1, single and dose 2 via an unspecified route of administration, in left arm on an unspecified date in 2021 (at 38-years-old)(Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history was none. Known allergies were none. The patients concomitant medications were none. Patient had not received any other vaccine in four weeks. The patient stated on 31Mar2021 at 13:15, she couldn't feel or move her tongue. It seemed swollen and numb. she couldn't move it for about a week. Then she had the small hole underneath her tongue squirt spit and then she could move it. Then after that patient had canker sores appear all inside her mouth and the veins underneath her tongue began turning . Patient tongue began to feel scorched, the sores would appear on her jaw and inside her lip. After using Ceapocal mouth wash it subsided. After taking the second shot the doctor prescribed her medication just in case it happened again. To this day her tongue still feels scorched tingling and numbness sensation. The events did not result in emergency room/ physician office visit. The patient received treatment for the events (magic mouthwash/ diphenhydramine 25 mg capsule/me). Patient doent had covid prior vaccination and was not tested to covid post vaccination. The outcome of the events was recovered with lasting effects. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518048
Sex: F
Age:
State: NY

Vax Date: 04/04/2021
Onset Date: 04/05/2021
Rec V Date: 07/31/2021
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: Migraine; Headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ew0150) via intramuscularly in left arm on 04Apr2021 at 12:15 as dose 1 single (at the age of 44-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. There were no prior vaccination within 4 weeks. The patient stated that, twelve hours after the first dose, on 05Apr2021 at 00:15, patient developed a migraine, headache, which lasted (on and off) for a day. Patient also received second dose of BNT162b2 (ew0172) via intramuscularly in left arm on 25Apr2021. There were no relevant tests done. Therapeutic measures were taken as a result of the events (unspecified). The outcome of the events was recovered on 06Apr2021.

Other Meds:

Current Illness:

ID: 1518049
Sex: F
Age:
State: PA

Vax Date: 02/25/2021
Onset Date: 03/11/2021
Rec V Date: 07/31/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Acute Massive Pulmonary Embolism detected via CT scan; Syncope; Severe anemia; Leg pain; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Long term effects require continuous use of blood thinners; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 09:00 (at the age of 34-years-old) as Dose 1, Single for COVID-19 immunization. Medical history included none. Concomitant medications included desogestrel, ethinylestradiol (APRI) taken for an unspecified indication, start and stop date were not reported. Patient received vaccine Facility in: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Event occurred on 11Mar2021, exactly two weeks following 1st dose of COVID vaccine. Acute Massive Pulmonary Embolism detected via CT scan following sudden leg pain and syncope. Negatively impacted cardiac, liver, and kidney function. Long term effects require continuous use of blood thinners. Presently experiencing severe anaemia treated through infusion treatments. Continued follow up required with Gastroenterology, Cardiology, Pulmonology, Hematology, and Gynecology. Patient visited Emergency room/department or urgent care. The events assessed as serious (Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage). Treatment was received for the events as infusion. Patient admitted in hospital for 4 days. The patient underwent lab tests and procedures which included computerised tomogram: acute massive pulmonary embolism and acute massive pulmonary embolism detected via CT scan following sudden leg pain and syncope, sars-cov-2 test: negative on 11Mar2021 Nasal Swab. The outcome of the events was reported as recovering.

Other Meds: APRI

Current Illness:

ID: 1518050
Sex: F
Age:
State: LA

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 07/31/2021
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: TIA; headache on half of her head going down to the back of her neck; face was numb/arm felt tingly and was a little numb; arm felt tingly and was a little numb; left leg felt weird; left knee achy (joint pain); ear sounded like she was under water; vision was blurry in one eye; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0178; Expiry Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 17Jul2021, the patient experienced tia (transient ischaemic attack), headache on half of her head going down to the back of her neck, face was numb/arm felt tingly and was a little numb, arm felt tingly and was a little numb, left leg felt weird, left knee achy, ear sounded like she was under water and vision was blurry in one eye on 16Jul2021. NDC number of Covid vaccine was unknown. Investigation Assessment was provided as yes. The reporter declined to provide her email. Caller added that two of her family members are ER doctors. She called them and told them what her symptoms were. She wasn't sure if they were normal. She was told that the symptoms were normal but since they were all on one side it was not normal. She had TIA symptoms. She had a headache on half of her head going down to the back of her neck. Her face was numb. Her vision blurry in one eye. Her arm felt tingly and a little numb. It wasn't extreme. Her left leg felt weird. Her left knee was achy like joint pain. Her ear sounded like she was under water. She went to the ER and was released. She still has some mild headache. It is not concerning. It is now all over her head. She was told to take a baby aspirin and to follow up with a neurologist and PCP. She has had all of her childhood vaccines and a tetanus booster. She is pro-vaccines. Caller is concerned about her medical bills. She did what she was supposed to. She is afraid she will have astronomical medical bills resulting from this and it will be a huge burden to bear. The patient is worried if this isn't the end there will be more to come. What is the normal process for figuring this out? If someone has a reaction and needs medical care do they just pay for it or is there a resource? She is not looking to sue or do anything crazy. Its a rare occurrence. Vaccination Facility Type was a Pharmacy/Drug Store. History of all previous immunization with the Pfizer vaccine was not considered as suspect. No additional Vaccines was Administered on same date of the Pfizer Suspect. The adverse event caused emergency room visit and no Physician Office visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures on 18Jul2021 which included blood test: ok. She was told that they were all ok, computerised tomogram head: ok. She had a CT of the head/She was told that they were all ok, magnetic resonance imaging: ok . She was told that they were all ok, urine analysis: ok. She was told that they were all ok.Therapeutic measures were taken as a result of tia, headache, hypoaesthesia, vision blurred, paraesthesia, limb discomfort, arthralgia, ear discomfort. Outcome of the event TIA, vision was blurry in one eye, arm felt tingly and was a little numb, left leg felt weird was recovered on 18Jul2021, face was numb was recovered on 17Jul2021, event headache, left knee achy were recovering, ear sounded like she was under water was recovered on 17Jul2021. Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518051
Sex: F
Age:
State:

Vax Date: 07/14/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
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: some pain on her right chest/breast area; some pain on her right chest/breast area; tightness on the chest; regain her energy; pretty traumatic; vomiting; severe stomach pain so severe that got her up all night and almost makes her call 911; she slept a lot during this period; Diarrhea; shortness of breath (around 7:45); fast heart beating; fatigue; chills; nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional reporting for herself. A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 via an unspecified route of administration on 23Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization and had arm pain for about 24 hours on her right arm. Caller wanted to know the possible side effects were of taking the Pfizer's COVID-19 vaccine, and how long would the side effects last after receiving the second dose of the vaccine. It was reported that, she already received both doses of the Pfizer's COVID-19 vaccine and developed several side effects, she received the first dose on 23Jun2021 and she developed arm pain for about 24 hours on her right arm, she then received her second dose of the vaccine on Wednesday 14Jul2021, she was ok until Saturday when she started developing some side effects like: Diarrhea (present all morning until 7 on the evening), she also developed shortness of breath (around 7:45), when she was laying on her bed she started developing fast heart beating, severe stomach pain so severe that got her up all night and almost makes her call 911, next day she still had some stomach pain but not as severe, she spent the morning of Sunday vomiting, she also developed fatigue, chills (on Saturday night, Monday night and last night), she could barely get up due to severe fatigue and nausea on unknown date in Jul2021. On 20Jul2021 (Today) morning at 5 am, previous side effects started diminishing however she started to develop some pain on her right chest/breast area combined with a feeling of tightness on the chest, the pain diminished during the day and she currently has no pain but is still trying to regain her energy, she slept a lot during this period. She received both of her vaccines on the right arm. She spoke previously with an agent on Pfizer but she did not report the chest pain as part of her experience. She described her general experience as "pretty traumatic" on unknown date in Jul2021. Per attached CONS, not all side effects have an specific temporality, some of the local side effects have an average duration of 1-2 days, other more systemic side effects like lymphadenopathy require more time to be resolved (around 10 days). Per PI, 6.1 Clinical Trials Experience, LAB-1457-10.0, Revised: 25Jun2021, data collected from the clinical trials have a range of dates from 7 to 30 days after receiving the second dose of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1518052
Sex: F
Age:
State: AR

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tongue numb on the end/her tongue is still numb, on the tip not even halfway up; tired; little chill; cold; couldn't swallow/she has always had a swallow problem but last night she could tell it was intense; achy, and neck feels achy; achy, and neck feels achy; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 2 via an unspecified route of administration on 19Jul2021 (Lot Number: EW0127) as a single for COVID-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing Caller stated that she is a heart patient, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine dose 1, (Lot number EW0186 expiry date was not reported) via unspecified route of administration at left arm on 28Jun2021 for COVID-19 immunisation. The patient did not received vaccination within 4 weeks. The patient took second dose of vaccine and at four in the morning she woke up. She was tired, a little chill and on the second shot she could not swallow, and her tongue was numb on the end. She took omeprazole for swallowing and she had always had a swallow problem but last night she could tell it was intense. She was suggested to take a Benadryl (diphenhydramine) 25 mg and it helped to get the swallowing down and her tongue was still numb, on the tip not even halfway up. It scared her. She called her doctor, and she was going in for an Epi (epinephrine) pen today just in case her tongue gest swollen. It was reported that for achy and neck pain the patient did not receive any treatment. Outcome of the events was Hypoesthesia oral, Chills, Dysphagia, Nasopharyngitis Unknown Fatigue, Neck pain and Pain was Not recovered.

Other Meds:

Current Illness:

ID: 1518053
Sex: F
Age:
State: OH

Vax Date: 07/09/2021
Onset Date:
Rec V Date: 07/31/2021
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: major asthma attack; heart was enlarged; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0181) via an unspecified route of administration in left arm on 09Jul2021 at 13:30 in afternoon as dose 1 single (at the age of 71-year-old) for COVID-19 immunization. Medical history included blood pressure high, arthritis. Concomitant medications included took like sixteen different medication. It was reported that patient put off getting her vaccine that on the 9th she had the first dose and she was fine until the 18th and she had a major asthma attack and had to go to the hospital (Further clarification unknown) and they told her that her heart was enlarged and she saw that can be one of the reactions and she wanted to know if it you thought that it would be nine days later that she will have that because she just had a chemical stress test and her heart was fine. Patient was supposed to get it second one on the 30th but she wanted to know if this could be the cause of it, she was not going to get it, that's what she wanted to know. Patient stated that I have not had an asthma attack in years and I got the side effect after I got this shot. Patient stated the hospital did all kind of blood test Sunday and results were unknown. It was reported that events were persisting and it's not getting any better at all. Patient received breathing treatment (Further clarification unknown) and Prednisone. Patient stated, I just wanted to know whether she should go ahead and get the other shot because I did not want anymore of these reactions, I mean, I thought I was gonna had to back to the hospital during the night. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm