VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1497509
Sex: F
Age:
State: IL

Vax Date: 03/06/2021
Onset Date: 04/01/2021
Rec V Date: 07/23/2021
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: started frailing with shivers and shaking uncontrollably on and off; diarrhea; aching; chilling; I was so weak and I slept so much; WBC increased; Mean corpuscular hemoglobin low; Platelet count high; Monocyte count high; Neutrophil count high; Flu symptoms; stomach flu symptoms; extreme dry heaves; she thought was the flu; Vomiting; nausea; had a feeling of shivers that was not normal; headaches; had a feeling of shivers that was not normal; This is a spontaneous report from a contactable other HCP (patient herself). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, batch/lot number: unknown, expiry date: unknown) via unknown route of administration, in right arm on 06Mar2021 08:00 (age at vaccination: 72) as DOSE 2, SINGLE for Covid-19 immunisation. Patient medical history included ongoing high blood pressure ever since she was overweight, clarifying she was diagnosed about 30 years ago. Her high blood pressure was controlled by medication. Patient previously received first dose of vaccine (Lot Number: EN6200), via unknown route of administration, in right arm, on 13Feb2021, as DOSE 1, SINGLE for Covid-19 immunisation. After vaccination, she had 4 events that lasted over a 2-month period after receiving 2nd Pfizer vaccine dose. It all started the second week of April. She ended up with what she thought was the flu. The 1st event was extreme dry heaves, diarrhea, vomiting, aching and chilling, no fever. She had the flu-like symptoms for several days but didn't have a temperature. She said it was not normal for her to not have a temperature when she had the flu. She eventually got better. It was reported she had recently changed doctors because her primary care doctor had retired. Her new doctor had ordered blood work on 01Apr2021, and that blood work was fine. About a week and a half after her doctor's appointment, her son called her to tell her he had come down with the stomach flu. After she spoke to her son over the phone, she had stomach flu symptoms, clarified as nausea and vomiting. A couple weeks later she was out eating, and when she got home, had 30 mins of very mild shivers that was not normal. She put a quilt, blanket, and sheet over herself, and was shaking so hard for a couple days. She said she didn't know what it was that caused the shivers. Her shivers happened, again, a week and a half later. She saw her doctor, and her doctor told her the shivers were a reaction to the COVID-19 Vaccine. Her doctor told her he had seen the same thing (shivers) happen in a few of his other patients. Patient stated she went to her Dr and he prescribed dexamethasone. She said she took the Dexamethasone 2.5mg for 5 days, and she did not have the Dexamethasone 2.5mg NDC, Lot, and Expiry Date. She said she had the normal Dexamethasone side effect of insomnia, but the Dexamethasone helped her immensely. She was so weak and slept so much. It was reported she had about 30 minutes of slight shivers a week and a half after she took the Dexamethasone 2.5mg. She said she hoped her doctor's diagnosis was correct. She said she hadn't had anymore shivers since then. She took it in June and all the shaking went away. She had taken Tylenol for headaches that she experienced occasionally during that time but did not know if the headaches were related to the COVID-19 Vaccine. Patient heard Pfizer was recommending a COVID-19 Vaccine booster shot, if the FDA approved. She wondered if anyone else reported anything like she experienced. She said she didn't know what else would have caused her symptoms. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her questions. She went to her first doctor appointment on 01Apr2021 for a new patient visit, clarifying she was not sick at the time. She had bloodwork done on 08Apr2021, and her bloodwork was OK, with no problems whatsoever. She donated blood through a blood drive on 21Apr2021. On 07Jun2021, she had bloodwork done, again, after she made a doctor's appointment for her shivers. Her bloodwork was not normal, clarifying her WBCs were elevated (15.5 x 1000), her Mean Corpuscular Hemoglobin Cone was low at 31.5 (reference range: 32.0-35.0), her Platelet Count was high at 424 x 1000 (reference range: 140-350), her Monocyte Count was high at 1.22 x 1000, and her Neutrophil Count was high at 12.7 x 1000. She was normally a very healthy person and was current on her flu and pneumonia vaccines. She was getting her second shingles shot, clarifying she had a prior shingles vaccine a long time ago that was 50/50 (effective). She said she was going to go to Walmart today to get her first of two Shingrix Vaccine doses. She said she wanted to get the second Shingrix dose before her flu shot later this year. Patient was concerned about the 3rd shot of Covid-vaccine and having the same symptoms. She was replied that as part of Pfizer and BioNTech continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. The use of a 3rd or booster dose is not recommended or authorized, and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information (name) authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It was thought that the effects seen against the Beta variant may also be seen in the Delta variant. They were doing studies to confirm this. They expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. For HCPs with general inquiries about booster doses, please refer to the SRD titled -Administration of More Than a 2-Dose Series (Booster Dose). The outcome of event for extreme dry heaves, flu, shivers, feeling abnormal was recovered on an unspecified date, for vomiting it was recovering, and the rest unknown. Communication: The caller was provided with phone number of #, option 3, and hours of operation of Monday through Friday 9AM to 5PM, prior to warm transfer; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Shaking, Retching, flu, vomiting .nausea, chills, viral GI ,feeling abnormal) and the suspect drug cannot be excluded , The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: FLU VACCINE VII

Current Illness: Blood pressure

ID: 1497510
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: a patient who received the vaccine and got ill; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported for a female patient. A female patient of an unspecified age 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 2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that a patient who received the vaccine and got ill on an unspecified date in 2021. It was reported that caller was the consumer, wanted to know the exact percentage of each ingredient of the Pfizer COVID 19 vaccine. She believed that the vaccine caused cardiac arrest, DVT and other cardio related diseases. Caller was very upset with Pfizer since she believed that there was more ingredients in the vaccine that was not publicized. She also mentioned that the fact sheet provided for the recipients does not include the percentage of each ingredients. Even the pharmacists and doctors cannot provide her information. She wanted to have the full list of the mRNA vaccine. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]- N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol),0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Insisted to speak with higher position, she believed that someone would have an answer for her. She wanted to speak with the next level since she believed that there were still more information available with the specialist II. Outcome of the event was reported as Unknown. Information on the Batch/lot number has been requested

Other Meds:

Current Illness:

ID: 1497511
Sex: F
Age:
State: WI

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 07/23/2021
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: The second dose was prepped by adding normal saline into the vial in front of her before being administered.; The second dose was prepped by adding normal saline into the vial in front of her before being administered; Caller reported hair loss post vaccination/Second dose: she has a hair brush and it's full of her hair; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 21Apr2021 (age at vaccination:63 Years) as dose 2, single for covid-19 immunisation. Patient did not received other vaccines within 4weeks prior to vaccination. Medical history included left mastectomy from an unknown date and unknown if ongoing, chemotherapy from 2001 to an unknown date she had chemotherapy about 20 years ago. The patient concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as dose 1, single for covid-19 immunisation. The caller reported hair loss post vaccination/second dose: she has a hairbrush and it was full of her hair on 2021. The second dose was prepped by adding normal saline into the vial in front of her before being administered on 21Apr2021. She reported she cannot have anything done to her left arm as she had a left mastectomy. She started to notice her hair loss about a week after receiving the first Covid 19 vaccine. She knew she was losing her hair because the hair loss was the same as when she had chemotherapy about 20 years ago. When probing for information on her medical history and concomitant medications she reports she had been taking all her medications normally. She also tried to rule out the hair loss being related to any of her medications, but nothing has changed. She added that with the second Covid 19 vaccine she reported the nurse drew up sterile saline, added the sterile saline to the Covid 19 vaccine vial, then withdrew from that Covid 19 vaccine vial a dose and administered the Covid 19 vaccine. This did not make any sense to her. The nurse told her it was, so the vaccine lasted longer. The outcome of the event alopecia was not recovered and the outcome of the events product preparation error and poor quality product administered was unknown.

Other Meds:

Current Illness:

ID: 1497512
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: little bit of soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). An 83-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received his first dose of the vaccine on Friday and that he was "doing well" with a "little bit of soreness" and knows "that was normal". He also said his wife received both vaccines and is doing well. He commented that they are both trying their best to protect themselves and that he was thankful for the opportunity to have the vaccine. Caller asked what the dosage of the vaccine was, if the dose was the same for someone who was 12 years old as for himself, and what the dose for the second shot was the same as the first. The clinical outcome of the events was reported as unknown. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497513
Sex: F
Age:
State: CA

Vax Date: 07/03/2021
Onset Date: 07/01/2021
Rec V Date: 07/23/2021
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: She had body aches; She had a headache.; She woke up about 4:00AM with flu like symptoms, she was shaking with chills, nauseous and sweating.; She woke up about 4:00AM with flu like symptoms, she was shaking with chills, nauseous and sweating.; She woke up about 4:00AM with flu like symptoms, she was shaking with chills, nauseous and sweating.; The next day, she still felt bad.; On the third day, she developed a sore throat. The next day her throat went from sore to scratchy to swollen.; On the third day, she developed a sore throat. The next day her throat went from sore to scratchy to swollen.; She is running a fever, about 100 degrees Fahrenheit.; She is blowing her nose a lot now, it is in her head. She feels like she has a sinus infection. She is blowing blood out of her nose.; She is blowing her nose a lot now, it is in her head. She feels like she has a sinus infection. She is blowing blood out of her nose.; This is a spontaneous report from a contactable consumer (patient, herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EUA0198) dose 1 via an unspecified route of administration, administered in the left arm on 03Jul2021 18:30 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Her and her son both received the Pfizer COVID-19 vaccine on 03Jul2021. On 04Jul2021, the patient experienced she woke up about 4:00am with flu like symptoms, she was shaking with chills, nauseous and sweating. On 05Jul2021, the patient had body aches and had a headache. On an unspecified date in Jul2021, the next day, she still felt bad. On the third day, she developed a sore throat. The next day her throat went from sore to scratchy to swollen. She was running a fever, about 100 degrees Fahrenheit. she was blowing her nose a lot now; it was in her head. she felt like she had a sinus infection. she was blowing blood out of her nose. She felt fine right after. She received the COVID-19 vaccine about 6:30PM. Whenever she got home, she was fine. Whenever she went to bed, she was fine. She woke up about 4:00AM with flu like symptoms, she was shaking with chills, nauseous and sweating. She was not alarmed by it. The next day, she also had body aches and a headache. The next day, she still felt bad. She asked her mom if she could take Tylenol or Aleve, and her mom said yes. So, she started taking Aleve. On the third day, she developed a sore throat. The next day her throat went from sore to scratchy to swollen, that started on Friday. She still had a sore throat that feels swollen and was scratchy. She also called her Pharmacy, and they took her report over the phone, and they told her to call Pfizer directly. She was running a fever, about 100 degrees Fahrenheit. She was blowing her nose a lot now; it was in her head. She feels like she had a sinus infection. She was blowing blood out of her nose. It had over a week since she received the COVID-19 vaccine. She thinks that it had gotten worse because it progressed to a sore throat and not being able to talk. The day before yesterday she felt nauseous. She was not nauseous now; she thinks that the nausea had now subsided. The patient states that she was previously working on completing a report with someone, but she had to take a business call and was unable to complete the full report. The patient was calling back to provide some more information on the side effects she experienced from the COVID 19 Vaccine. The patient reports that she got through some patient details and event details with the previous agent, but she did not provide product details to the previous agent. The patient states that she had like this with her symptoms for a week. The patient had the COVID virus in Dec and she was very sick. The patient got the vaccine because now there was this delta coming around and she didn't want to get sick. There was a medical information request was yes. The patient was hoping to get through to lab people or someone who can tell her how long she can expect to feel like this. She does not have a headache now because she had taking Mucinex D for the past two days. As long as she was taking Aleve she feels better. As soon as the Aleve starts to wear off, she does not feel good. She was doping herself up on medication to feel better. She was calling about the Pfizer COVID-19 vaccine. They told her to give Pfizer the lot number of EVO988 or something. She was calling to report side effects. She states she left a message with Pfizer over the weekend. Reason for no lot number of Pfizer COVID-19 vaccine was complainant hung up abruptly/transfer incomplete. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Dec2020. The patient received treatment with Tylenol or Aleve and Mucinex D. The outcome of the events she woke up about 4:00AM with flu like symptoms, she was shaking with chills, nauseous and sweating was not recovered, she had body aches was recovered on an unknown date in Jul2021, she had a headache was recovered on 09Jul2021, all other events outcome was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1497514
Sex: F
Age:
State:

Vax Date: 07/05/2021
Onset Date: 07/01/2021
Rec V Date: 07/23/2021
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: Arm is really swollen; It was on fire; After the second one, it is very swollen and red, the whole arm, the whole upper arm, there's a fever in there; After the second one, it is very swollen and red, the whole arm, the whole upper arm, there's a fever in there; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization and did not experience any adverse reaction. Caller stated she had her second Pfizer shot on 05Jul2021 and on an unknown date in Jul2021, her arm was really swollen and it was on fire. Caller stated the fire was kind of gone out now (on an unknown date in Jul2021). Caller stated she was really concerned, and reported they gave her the shot at home. Caller stated the first one was fine, but after the second one, it was very swollen and red, the whole arm, the whole upper arm, there was a fever in there and also stated what she really needs to know was if those people that gave her the shot could come back and check her arm. The outcome of the event It was on fire was recovered on an unknown date in Jul2021, whereas for rest of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497515
Sex: F
Age:
State:

Vax Date: 05/08/2021
Onset Date: 07/11/2021
Rec V Date: 07/23/2021
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: She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; She is experiencing mild pain on the upper arm where she got the vaccine. It is not even that painful, it comes and goes.; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 08May2021 10:15 as (At the age of 41-years) DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have patient history and investigation assessment. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0162) on 17Apr2021 at 10:28AM into left arm for COVID-19 immunization. The patient experienced she is experiencing mild pain on the upper arm where she got the vaccine. it is not even that painful, it comes and goes on 11Jul2021. It was reported that Caller is a consumer who received her Pfizer-Biontech Covid19 vaccine series approximately 2 months ago. She is now reporting she is experiencing mild pain on the upper arm where she got the vaccine. She states it's not even that painful, just a sensation that she was noticing, and that the sensation comes and goes. Reporter was asking Has this been reported before. Response: Spoke from Fact Sheet Sect 6.1: Solicited Local and Systemic Adverse Reactions Across both age groups, 18 through 55 years of age and 56 years and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). Later patient was reported that She now has a very mild pain on her upper arm where she received the covid vaccine. It is not even that painful, it comes and goes: It just began yesterday. She cannot even call it a pain because it is very mild. She is just concerned because she is not sure what it is. It is bothering her, but it is very mild. It happens maybe one or two times an hour. It is so mild that she did not take Ibuprofen. Reporter seriousness for events: Unspecified. The outcome of events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497516
Sex: F
Age:
State:

Vax Date: 07/02/2021
Onset Date: 07/01/2021
Rec V Date: 07/23/2021
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: her left hand (on the same arm where she got the vaccine) went numb and it stayed like that for a little while; Caller mentioned that she is also extremely nauseous since taking the vaccine; She also has rashes on her stomach; Her head is also really hot; She also had itching all over; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age 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 02Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that on 02Jul2021 the patient received first dose of vaccine and 45 minutes after being vaccinated, her left hand (on the same arm where she got the vaccine) went numb and it stayed like that for a little while. She further mentioned that on Jul2021 she was also extremely nauseous since taking the vaccine. She was very nauseous even without eating and she finds it hard to eat because of the nausea. She also had itching all over on Jul2021 and she has taken 4-6 Benadryl tablets to help with the itching. She also has rashes on her stomach on Jul2021. Her head was also really hot but it was not the kind that you get when you have fever. It was just hot. She finds that covering herself with ice packs helps with this adverse event. Patient wanted to know what to do with her adverse events (specifically treatment recommendations). She also mentioned that she had a side effect after the first dose of the vaccine, so should she get the second dose and if she should take the Moderna COVID-19 vaccine instead of the second dose of the Pfizer COVID-19 vaccine. Reporter complained that she has done her part, she has gotten the vaccine and now she needs help, and no one can give her treatment recommendations. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497517
Sex: F
Age:
State:

Vax Date: 06/19/2021
Onset Date: 06/23/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: the following Wednesday 23Jun2021 started developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day; the following Wednesday 23Jun2021 started developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day; This is a spontaneous report from a contactable consumer or other non hcp(patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number and Expiry Date was not reported), via an unspecified route of administration on 19Jun2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Other products was reported as Not provided. The patient received the first dose of the Pfizer Covid-19 vaccine on 19Jun2021 and On 23Jun2021(wednesday), the patient experienced developing a complaint of humming in her right ear or head that is intermittent in occurrence and still continues to this day. She is unable to receive the second dose of the Pfizer Covid-19 vaccine and was asked "Should I get the second dose?" Response included: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The patient reported that She received the 1st dose on 19Jun2021 and a week later, in the middle of that next week, she got, and it is still there, a humming in her right ear. She doesn't know if it is in her ear or in her head. It is real light and she is wondering if this could be a side effect and she just wants to know if anyone else has had this side effect. The outcome of the events was not recovered. Information on Lot/Batch information has been requested.

Other Meds:

Current Illness:

ID: 1497518
Sex: F
Age:
State: FL

Vax Date: 05/13/2021
Onset Date: 05/01/2021
Rec V Date: 07/23/2021
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: pressure on frontal lobes; experiencing severe migraine, 8 weeks after getting the first dose; pressure in the head; severe headache after the first dose/Stabbing pain in the head; Tingling; Her left foot went numb and felt like her foot was asleep; brain fog; This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0158 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13May2021 at 10:45 (age at vaccination: 32 years), as a single dose for COVID-19 immunization. The patient's medical history included Covid (she had Covid in January). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any vaccine within 4 weeks prior vaccinations and did not have any adverse effect prior vaccinations. Concomitant medication included doxycycline (Face was peeling from wearing masks and for breakout in face). Caller interested to know if the Doxycycline she took before the first dose of the Pfizer BioNTech Covid-19 Vaccine would have a potential effect on her body. Advised caller that the PI did not have information specifically on the interaction between Doxycycline and the Pfizer BioNTech Covid-19 Vaccine. Spoke from attached antivirals/antibiotics CONS doc. The patient stated that she had her first dose of the Pfizer BioNTech Covid-19 Vaccine on 13May2021 and did not get the second dose per HCP's advice due to severe headache after the first dose on 18May2021. She stated that she felt a lot of pressure on her head. She also stated that she took Doxycycline for 10 days but stopped a day before she got the first dose of the vaccine. Also mentioned to her that we normally stick to the normal dosing schedule specified in the PI to maximize the 95% efficacy rate 7 days after the 2nd dose. She has been having headaches since about 5 days after the vaccine and has had a lot of pressure on her head. It doesn't matter what the neurologist has recommended, nothing has touched it and asked had we seen something similar with other patients. It will be 8 weeks, tomorrow. The pain only stops when she was asleep. It was a constant head pressure and stabbing pain and tingling, which was constant. She went to a walk-in clinic. They wouldn't have any information about that. There were days where it was worse and actually didn't improve. She had tried migraine medications, over the counter medications and it didn't do anything. Some days were worse than others. The pressure on her frontal lobes did not go away at all and was a lot of pressure. If you were to wear a headband, right where it lands, it felt like she had a headband on all day long. It was so much pressure on the brain. She had stabbing pain in the head since she had Covid. It has been on and off. The pressure is all day, no matter what. The stabbing occurs throughout the day. She has tried Tylenol and Excedrin, which didn't touch it and, also tried Ibuprofen and tried migraine medications Nurtec and Ubrelvy. Tried these all and nothing worked. She honestly didn't want it. She already had Covid. She does work with a lot of patients. Her husband had Covid and has Long haulers, still dealing with problems from that. She wouldn't try getting it again. Doxycycline was stopped this the day before having the vaccine and did not continue after the vaccine. She had checked with her dermatologist who said it wouldn't counteract it and was on it for 10 days. Had to have started on 02May2021. It was a very low dose. Thinks it was like 50mg, once a day. A brain MRI was done on 26May2021, which showed up negative. Think it was 2 weeks after the symptoms started, so maybe 22 or 23 May, or no, it was 26May2021, which was the day she went to the walk in clinic. Caller laughed and said, Brain fog is real. Her left foot went numb and felt like her foot was asleep on 13May2021 at 10:45 AM. It was right after the shot and lasted a couple of hours, then went away. The adverse events did not require a visit to emergency room and physician office She went into a walk in clinic 26May2021, about 5 or 6 days after the headaches started and nothing was treating it. Caller reported and patient confirmed that they are experiencing severe migraine, 8 weeks after getting the first dose of the PFIZER-BIONTECH COVID-19 VACCINE and that they (physician) were already able to give the patient the medication, Neurtec but proves ineffective for the patient's migraine. Also, patient was not able to get the second dose of the vaccine due to this side effect. Outcome of the event her left foot went numb and felt like her foot was asleep was recovered on 13May2021 at 12:45, brain fog was unknown and for all other events, it was not recovered. Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Caller has been having headaches since receiving the first dose of the Covid 19 vaccine, 13May2021. Has tried Tylenol, Excedrin, Ibuprofen, Nurtec and Ubrelvy. Nothing has helped. Product strength and count size dispensed: unknown Additional lot numbers: Unknown, she does not have these with her. What they gave her were samples and she has thrown away the boxes. Is a sample of the product available to be returned, if requested (Y/N): No Packaging sealed and intact? not provided

Other Meds: DOXYCYCLINE

Current Illness:

ID: 1497519
Sex: F
Age:
State: MN

Vax Date: 04/13/2021
Onset Date: 04/20/2021
Rec V Date: 07/23/2021
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: Post menopausal hot flashes every day; Post menopausal hot flashes every day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8731, Expiration date not reported), via intramuscular in right arm on 13Apr2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization at hospital. The patient medical history included: high blood pressure and thyroid from an unknown date and unknown if ongoing. The patient was allergic to stone fruit. The patient concomitant medication included thyroid (ARMOUR THYROID), metoprolol tartrate (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL [IBUPROFEN]). The patient previously received codeine and experienced allergy on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown whether the patient had COVID prior vaccination. The patient was not COVID tested post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number ER8727, Expiration date not reported), via unspecified route of administration in right arm on 23Mar2021 14:45 (at the age of 58-year-old) as single dose for COVID-19 immunization. On 20Apr2021 16:30, the patient experienced Post-menopausal hot flashes every day. The patient did not receive any treatment for the event. The outcome of event was not resolved. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds: ARMOUR THYROID; METOPROLOL TARTRATE; ADVIL [IBUPROFEN]

Current Illness:

ID: 1497520
Sex: F
Age:
State: IN

Vax Date: 07/08/2021
Onset Date:
Rec V Date: 07/23/2021
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: This is a spontaneous report from a contactable consumer or other non-health care professional. A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0164), dose 1 via an unspecified route of administration, administered in Deltoid Right on 17Jun2021 10:30 as single dose and dose 2 via an unspecified route of administration, administered in Deltoid Right on 08Jul2021 10:30 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included hypersensitivity (allergic to everything), ongoing autoimmune disorder (she has high inflammation in her body related to an autoimmune thing going on that has not been identified) and congenital anomaly (had a birth defect with 50 surgeries). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (No AEs following prior vaccination). The patient previously took iron infusion and experienced adverse drug reaction. The patient experienced she had a sensitive reaction after both vaccines, so she took benadryl for it, she has had both doses of the vaccine and experienced dizziness after both on an unspecified date in 2021, her inflammation is already elevated on an unspecified date, throat feeling scratchy and closing, itching and throat feeling scratchy and closing on an unspecified date in 2021. Patient took Benadryl for event sensitive reaction. After the first dose dizziness resolved, however it has not resolved after the second dose, which she received on 08Jul2021. She says she has a really high SED rate, CRP, and other inflammation markers. Her doctors are trying to diagnose an autoimmune disease with lung involvement, maybe a connective tissue disease so her inflammation is already elevated. The patient stated 30 minutes before getting the second dose and after when she felt her throat feeling scratchy and closing. Afterward she was watched for over an hour and that was fine, she was fine. What she is wondering about is the dizziness which is debilitating. She had this with the first dose but it is way more severe with second dose. She is just wondering about it, she is not an anxious person, it is not anxiety. It hit within 10 minutes of getting the shot and she wants to know why and how long this will last. She took Benadryl for a day or 2 afterwards, this was not critical. They monitored her for an hour after the first dose, maybe longer for the second, and she was fine. This was true for both doses, the event resolved after a couple days. The dizziness last 3-4 days after the first dose. After the second it got worse 24 hours after the shot but at this point is has levelled off and is about the same and ongoing. The patient mentioned she also had itching. After the first shot it lasted 3 days. After the second dose it is still ongoing though she would say it is a little better. The itching is in the right upper arm. Then she says it is systemic and is sometimes her head, stomach, and leg. It drives her crazy and is all over, it is not constant but described as intermittent. The patient again confirms the symptoms are the same after both shots but worse after the second shot, just more intense. She also relays that there is other medication she has had reactions too. She knows she had iron infusion, 2 different one, that she had a reaction too. There are tons of drugs she has reactions to. AEs did not require the visit to emergency office/ physician office. No family medical history relevant to AEs and no relevant tests. The patient underwent lab tests and procedures which included c-reactive protein and red blood cell sedimentation rate with result high on an unspecified date. The outcome of the event her inflammation is already elevated was unknown, for events She explains she had a sensitive reaction after both vaccines so she took Benadryl for it and throat feeling scratchy and closing was recovered on an unspecified date in Jul2021, outcome of She has had both doses of the vaccine and experienced dizziness after both was not recovered and for event itching was recovering.

Other Meds:

Current Illness: Autoimmune disorder (she has high inflammation in her body related to an autoimmune thing)

ID: 1497521
Sex: M
Age:
State: SC

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/23/2021
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: potential not to get the second shot; headache; neck ache; fever; throwing up; This is a spontaneous report from a contactable consumer (grandparent). This consumer reported for a 12-year-old male patient (grandson). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 11:30 (At the age of 12 year old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller called on behalf of his grandson (12-year-old) who received the first dose of the Pfizer Biontech COVID-19 vaccine and on the same day he got the shot, he experienced headache, neck ache, fever, and throwing up on 07Jul2021. Stated that the headache gets better and comes better. Stated that it was tolerable and comes back. Stated that the fever comes and goes. Started throwing up 2-3 days ago. She wanted to know if those side effects were related to the COVID19 vaccine and if she needed to go to the doctor and if he could get the second dose. Caller also stated that the side effects outweigh the COVID shot, I do not want my grandchild to suffer like that. Vaccines were supposed to make you feel better, not sick. Caller asked if the vaccine was tested on children and if they had side effects. Wanted to know if she needed to go the doctor because he cannot live throwing up all the time. Stated that he had never been sick before. Stated that he was only 12 years old. Does not think that vaccine was adequate for children. Therapeutic measures included Ibuprofen for his headache and fever. Stated that he had cold compresses for the neckache. Stated that he had ginger ale and Pepto Bismol for throwing up. Outcome of the event headache and throwing up was reported as not recovered at this time of the time. Outcome of the event neck ache was reported as recovered on 11Jul2021. Outcome of the event fever was reported as recovering and outcome of the event potential not to get the second shot was reported as Unknown. Information about the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497522
Sex: F
Age:
State: NJ

Vax Date: 05/11/2021
Onset Date: 06/07/2021
Rec V Date: 07/23/2021
Hospital: Y

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: Severe vertigo; Cognitive impairment; Chronic fatigue; Speech issues; Vision difficulties; Numbness in face; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 11May2021 (Age at vaccination: 33 Years) as dose 2, single for covid-19 immunisation. Medical history included as blood cholesterol increased, gastroesophageal reflux disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. She received historical vaccine bnt162b2 (BNT162B2, Batch/Lot Number: EW0182) via an unspecified route of administration, administered in Arm Left on 2021. She has no allergies. She was no Pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jul2021, The patient experienced severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties, numbness in face. The patient was hospitalized for severe vertigo, cognitive impairment, chronic fatigue, speech issues, vision difficulties from 2021 to 2021. Presented to ER 2 weeks after 2nd shot. Admitted to hospital overnight. There was 2 days of hospitalization. She has taken Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient underwent lab tests and procedures which included blood test: inconclusive on 2021 All tests inconclusive,computerised tomogram head: inconclusive on 2021 All tests inconclusive , computerised tomogram neck: inconclusive on 2021 All tests inconclusive , magnetic resonance imaging head: inconclusive on 2021 All tests inconclusive. She has taken treatment as Meclizine for vertigo. It was not working. Therapeutic measures were taken as a result of severe vertigo. The outcome of the event (vertigo, cognitive disorder, fatigue, visual impairment, hypaesthesia) was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1497523
Sex: M
Age:
State:

Vax Date: 07/09/2021
Onset Date: 07/01/2021
Rec V Date: 07/23/2021
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: he was literally hit with the sensation that his back got thrown out/ His back and liver area is hurting.; I didn't lift anything, I didn't do any new activity./ it almost dropped me to my knees; His back and liver area is hurting.; back pain; This is a spontaneous report from a contactable consumer (patient himself). A 38-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot number and expiry date were not reported) via an unspecified route of administration on 09Jul2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for COVID-19 immunization. On 10Jul2021 he was literally hit with the sensation that his back got thrown out. On an unspecified date in Jul2021, his back and liver area was hurting. It came out of nowhere, I didn't lift anything, I didn't do any new activity. Then Saturday he was hit with literally the sensation that his back got thrown out. He was a healthy person. He does not even take Tylenol. He unfortunately was forced to take the covid vaccine. He was asking has anyone else reported this. His back and liver area was hurting. He thought that it would pass. It gets better, and here today it came back. Patient's concern was it returned again today, he was helping his 03-year-old son put on his seat belt when it hit him like it did on Saturday, it almost dropped him to my knees and guess his concern was that resurfaced fairly quickly and it never dissipated completely but it hit him like it did Saturday at work. The outcome of the event movements reduced was unknown and for all other events was not resolved. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1497524
Sex: F
Age:
State: WA

Vax Date: 04/17/2021
Onset Date:
Rec V Date: 07/23/2021
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: big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; big bump on her arm that was hot and swollen/lump on my arm which was very hot and sore; Big bump on her arm that was hot and swollen; Lump on my arm which was very hot and sore; Bump on my arm; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route on 17Apr2021 (at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. The patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ET6955), via an unspecified route on 27Mar2021(at the age of 49-year-old) into Arm right as a single dose for COVID-19 immunisation. Medical history included stress from an unknown date and unknown if ongoing (stress a lot). The patient's concomitant medications were not reported. She received her second dose of the vaccine on 17Apr2021 and had no side effects other than a bump on her arm that was hot, red, and really sore on an unspecified date in 2021. She received both doses, the only thing she had received as an adverse event was a big bump on her arm that was hot and swollen; just like a lump on her arm which was very hot and sore for a few days but that was all that happened. The patient underwent lab tests and procedures which included antibody test: negative on a negative antibody test after being fully vaccinated on an unspecified date in 2021. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1497525
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: the patient said she had yellow fluid coming out of her hand; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, with the first dose of the vaccine, on an unspecified date, the patient had yellow fluid coming out of her hand. The outcome of the event was unknown at the time of report. Information about lot/batch number is requested.

Other Meds:

Current Illness:

ID: 1497526
Sex: F
Age:
State: VA

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/23/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: I developed a limited range of motion with my left arm; I found that there is a problem called SCAR; When reaching up for reaching back there is pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Left arm on 30Mar2021 at 16:00 (at the age of 74-years-old) as dose 2, single dose for covid-19 immunisation. Medical history included fibromyalgia from an unknown date and unknown if ongoing, cervical disc 5 and 6 replace with a plate and screws in 1995 and panic attack from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Left arm on an unspecified date for covid-19 immunisation and sulphur, cortisone, ultram [tramadol hydrochloride], codeine, penicillin and experienced drug allergy. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 12Jul2021. It was reported that after the second covid-19 Pfizer vaccine, On 30Mar2021 at 21:00, the patient developed a limited range of motion with her left arm. When reaching up for reaching back there was pain. This was not present before the vaccine. When questioning this event, she found that there was a problem called SCAR. Treatment for adverse events was unknown. Adverse events resulted in Disability or permanent damage. The reporter assessed events as Serious with seriousness criteria of resulting in Disabling/Incapacitating and no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Congenital anomaly or birth defect. As of 12July2021, she was still having this problem. The outcome of events was Not recovered.

Other Meds: GABAPENTIN; SERTRALINE; LOSARTAN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1497527
Sex: F
Age:
State:

Vax Date: 06/30/2021
Onset Date: 07/02/2021
Rec V Date: 07/23/2021
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: Her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting; Her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 30Jun2021 as dose 2, single for COVID-19 immunization. The historical vaccine include 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 09Jun2021 as dose 1, single for COVID-19 immunization. The report was not related to a study or programme. The patient's medical history and concomitant medications were not reported. The patient experienced her shoulder blade muscle, the back of her arm, and the side of her arm has been hurting on 02Jul2021. Caller wanted to enquire if there were any reports of any muscle problems and she was wondering if she had not taken the vaccine just like everyone else and said that she might just go to the hospital. Patient got the 2nd dose of the Pfizer vaccine last 30Jun2021 and mentioned that it's been 10 days now and she was still experiencing muscle pain in her back and a pain in her shoulder blade and arms. She wanted to know if she needs to go to the hospital and needs some assistance. She got her first dose on 09Jun2021. The outcome of the event was non recovered. Information on the lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1497528
Sex: F
Age:
State: ID

Vax Date: 04/15/2021
Onset Date: 04/18/2021
Rec V Date: 07/23/2021
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: On day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm,; my upper torso well all enlarged and swollen; fever of 101 and was completely exhausted; completely exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Left Arm on 15Apr2021 09:15 AM (at the age of 50 years old) as DOSE 2, SINGLE for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included malignant melanoma (recovered). The patient has known allergies to Iodine, codeine, Cephdiner. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device Date was reported as 12Jul2021.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); ascorbic acid, betacarotene, biotin, calcium carbonate, calcium phosphate, chlorine, colecalciferol, cupric oxide, ferrous fumarate, folic acid, iodine, magnesium oxide, manganese sulfate, molybdenum, nickel sulfate, nicotinamide, pantothenic acid, phosphorus, potassium chloride, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon, thiamine, tin, tocopherol, vanadium, vitamin b12 nos, zinc oxide (MULTIVITAMINS AND MINERALS PLUS LUTEIN) and Birth control. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: unknown), as first dose in arm Left on 17Mar2021 as dose 1, single for COVID-19 immunization. On 18Apr2021, day 3 after receiving the second dose of the Pfizer vaccine, all the lymph nodes on the left side of my body from behind my ear, down my jawline, down my neck, under my arm, my upper torso well all enlarged and swollen. I had a fever of 101 and was completely exhausted. This lasted for 10 days before she started feeling better. The fever would come and go. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included pyrexia: 101 Fahrenheit on 18Apr2021. The outcome of the events was recovered on an unspecified date in 2021. Was requested for additional information Information about lot/batch number is requested.

Other Meds: ZYRTEC ALLERGY; MULTIVITAMINS & MINERALS PLUS LUTEIN

Current Illness:

ID: 1497529
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single dose and via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a suppressed immune system. It was reported that patient had a suppressed immune system and had received the first two vaccination shots for COVID-19 but was interested in participating in a trial for a booster if one is available. Outcome of the event was unknown. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497530
Sex: F
Age:
State:

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: She has headache and chills after receiving the vaccine.; She has headache and chills after receiving the vaccine.; Body aches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 67-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), via an intramuscular route of administration (at the age of 67-years), administered in arm right on 09Jul2021 15:00 as dose 2, single for COVID-19 immunization in pharmacy. Medical history included ongoing arthritis ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine , diabetes and bronchitis from an unknown date and unknown if ongoing she thinks they said she has bronchitis, but it was not really bad; she has an inhaler but she never , sinus infection from an unknown date and unknown if ongoing she thinks she has had maybe a sinus infection or something like that , rash from an unknown date and unknown if ongoing she had a history of having had a rash that comes up on her hand and sometimes on legs but went to dermatologist gave her some cream that cleared it up, blood cholesterol from an unknown date and unknown if ongoing , and provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Concomitant medication included 40mg simvastatin once daily taken for blood cholesterol from an unspecified start date and ongoing; 5mg enalapril once daily for diabetes mellitus. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration (at the age of 67-years), administered in arm right on 18Jun2021 between 13:30-14:00 as dose 1, single for COVID-19 immunization. The patient historical vaccine included flu shots and stated that she just always gets the flu shot every year and never had any reaction with those. On 09Jul2021, the patient experienced headache, chills and body aches. Caller stated she received the first dose of the Pfizer Covid 19 vaccine on 18Jun2021. Last Friday she received the second dose, but the Tuesday prior to that she developed a rash. She also stated she has headache and chills after receiving the vaccine. The patient who had been administered both doses of the Pfizer-BioNTech Covid-19 Vaccine. She initially reported having had no reaction to the first dose of the Pfizer-BioNTech Covid-19 Vaccine shot; but later reported having onset of rash on 06Jul2021 that has worsened. She asked for further information on side effects, rash, and if she should go to her doctor about this. On morning of 10Jul2021, the bad headaches were not as bad, currently a little bit better. She started taking some Tylenol for this event and the body aches. Body aches: She was real achy, body aches really aching all over, but not now. Patient had preexisting arthritis in her knees and spine that were ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine; she thinks it might had been the Arthritis that was really hurting her back and all over starting on 09Jul2021 and 10Jul2021 but it was not going on right now-outcome improved. She checked with her daughter because both caller and her daughter got the second dose of Pfizer-BioNTech Covid-19 Vaccine around 15:00 on 09Jul2021 but her daughter has not had any side effects. Therapeutic measures were taken as a result of she has headache and chills after receiving the vaccine. and for body aches. The clinical outcome for the events she has headache and body aches was reported as recovering and the event chills was reported as unknown.

Other Meds: SIMVASTATIN; ENALAPRIL

Current Illness: Arthritis (Ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine)

ID: 1497531
Sex: M
Age:
State: HI

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: myocarditis; fever; headache; tender vaccination site; This is a Literature report. This reporter reported similar event for two patients, this is the first of 2 reports. Authors describe, for the first time, adolescents presenting with chest pain and imaging evidence of myocarditis in close temporal association with the BNT162b2 vaccination. Two adolescent males, aged 15-16 years of age, presented in the Emergency Department with chest pain within 3 days of BNT162b2 vaccine administration, one of them after the first, the other after the second dose of the vaccine. One patient noted mild and typical vaccine-related symptoms including tactile fever, headache, and tender vaccination site within a day of vaccine administration, while the other patient had no such symptoms. Within a couple of days after vaccination, both patients developed acute onset, mid-sternal, non-radiating chest pain associated with chest tightness. One patient had a history of mild intermittent asthma, otherwise, they had no known medical conditions and no prior surgeries. Their initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure. They had a normal cardiac exam without a murmur or friction rub. Inflammatory markers were mildly elevated. Complete blood count was notable for neutrophilia without leukocytosis. Cardiac enzymes were elevated in both cases at presentation. Infectious workup including immunoglobulin G and real-time reverse transcription polymerase chain reaction for SARS-CoV-2 and respiratory viral panel polymerase chain reaction containing the most common aetiologic agents of viral myocarditis were negative in both patients. Chest X-rays were unremarkable. Electrocardiograms showed ST elevation and T wave inversion in lateral leads. Both patients had normal left ventricular systolic function on echocardiogram. Small areas of increased echogenicity could be detected throughout the myocardium in one of the patients, especially in the interventricular septum and lateral wall of the left ventricle. Cardiac MRI with early gadolinium enhancement using electrocardiogram- gated turbo spin echo T1-weighted sequences showed mild global early enhancement of the myocardium, with pronounced enhancement in the subendocardial layer of the left ventricle, findings consistent with inflammation of the myocardium without evidence of myocardial necrosis, fibrosis, or oedema. Cardiac catheterisation was not performed as there was low suspicion for acute coronary syndrome and the cardiac MRI was consistent with myocarditis. One patient received intravenous immunoglobulin, while the other patient improved without any treatment. Echocardiograms continued to show normal left ventricular function throughout the hospitalisation. Troponin T peaked at 832 and 1210 ng/L, but creatine kinase myocardial band did not increase beyond initial levels. Chest pain resolved a day after admission and both patients were discharged from the hospital within 4 days of admission. Electrocardiograms showed improved, but continued mild ST segment elevation at discharge. Authors present two adolescents with evidence of myocarditis shortly after BNT162b2 vaccination. The presentation of these adolescents were consistent with myocarditis based on clinical, imaging, and laboratory findings, and no other alternative aetiology was found. Authors excluded acute or recent COVID-19 infection and did not find evidence of other viral aetiologies. The temporal association with the preceding COVID-19 vaccine raised the suspicion of a vaccinerelated self-limited myocarditis. This case series suggests that chest pain within a week of COVID- 19 vaccination with an mRNA vaccine should raise the suspicion of focal myocarditis. A 15-year-old male patient received bnt162b2, 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. Medical history included mild intermittent asthma. The patient's concomitant medications were not reported. The patient experienced myocarditis on an unspecified date 3 days after the vaccination, fever, headache, and tender vaccination site on an unspecified date within a day of vaccine administration. The patient was hospitalized for event myocarditis. The patient underwent lab tests and procedures which included CKMB (normal range: less than 4.1): 54.6 iu/l at presentation, elevated; 54.6 iu/l peak. Blood pressure: 119/72 mmhg. Temperature: 37.2 centigrade. Chest x-ray: unremarkable. CRP (normal range: less than 5.0): 18.5 mg/l. Echocardiogram findings: LVEF 63%, increased patchy echogenicity of the myocardium, normal left ventricular systolic function. LVEF: 63 %. Electrocardiogram findings: ST segment elevation in lateral leads, left axis deviation, normal left ventricular function throughout the hospitalisation. Electrocardiogram findings: improved, but continued mild ST segment elevation. Complete blood count: notable for neutrophilia without leukocytosis. Heart rate: 116 beats per minute. Inflammatory markers: mildly elevated. Cardiac MRI: unknown results. Cardiac enzymes: elevated. NT-proBNP (normal range: 0-125): 108 pg/mL at presentation, 498 pg/mL peak. SpO2 in room air: 96%. Procalcitonin (normal range: less than 0.10): 0.15 ng/ml. ESR (normal range: 0-15): 7 mm/hr. Respiratory rate: 18. Respiratory viral panel PCR: Negative. SARS-CoV-2 IgG (Normal range: less than 1.40 index): Negative (0.24). SARS-CoV-2 RT-PCR: Negative. Troponin T (normal range: less than 20): 304 ng/L at presentation, 832 ng/L peak. The patient received treatment of intravenous immunoglobulin for event myocarditis. The outcome of event myocarditis was resolved, outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile and plausible temporal relationship, a possible causal association between the event "myocarditis" and the suspect drug 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.,Linked Report(s) : US-PFIZER INC-2021881937 same article, product, different patient, similar event

Other Meds:

Current Illness:

ID: 1497532
Sex: F
Age:
State: TX

Vax Date: 04/03/2021
Onset Date: 04/21/2021
Rec V Date: 07/23/2021
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: Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; Severe exacerbation of my peripheral neuropathy with severe burning,tingling,numbness,pain; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: Er8737) via an unspecified route of administration (age at vaccination 59-year) in Left Arm on 03Apr2021 as dose 1, single for COVID-19 immunization. Medical history included Peripheral neuropathy, High cholestrol and Arthritis from an unknown date and unknown if ongoing. Concomitant medications included gabapentin; celecoxib (CELEBREX); rosuvastatin calcium (CRESTOLIP) taken for an unspecified indication, start and stop date were not reported. No known drug allergies were reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 21Apr2021 the patient experienced severe exacerbation of my peripheral neuropathy with severe burning, tingling, numbness, pain. AE resulted in Doctor or other Healthcare professional office/clinic visit. No treatment was received for the adverse events. The clinical outcome of the events was recovered with sequel (recovered with lasting effects) on an unspecified date. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds: GABAPENTIN; CELEBREX; CRESTOLIP

Current Illness:

ID: 1497533
Sex: F
Age:
State: NY

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 07/23/2021
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: Increase in Tonic Clonic seizures,; A total of 6 seizures which are ongoing to this day; This is a spontaneous report from a contactable consumer (patient herself). A 26-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot number: EW0175, Expiration Date was not reported), via an unspecified route of administration in right arm on 29Apr2021 11:15 (at the age of 26-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history included epilepsy, ADHD. Concomitant medication included zonisamide, methylphenidate hydrochloride (CONCERTA), folic acid (FOLIC), all taken for unknown indications from an unknown date. Other medications received in two weeks included Kelnor birth control. The patient previously took celontin and experienced drug hypersensitivity. No other vaccine received in fou rweeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for COVID-19 since the vaccination. On 29Apr2021 03:00 PM, the patient experienced increase in tonic clonic seizures, A total of 6 seizures which are ongoing to this day. Treatment was received for the events. Adverse event treatment includes rescue medication. The outcome of the events was unknown.

Other Meds: ZONISAMIDE; CONCERTA; FOLIC

Current Illness:

ID: 1497534
Sex: M
Age:
State: HI

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
Hospital: Y

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: myocarditis; This is a Literature report from Cardiology in the Young, 2021, DOI: 10.1017/S1047951121002547, entitled "Self-limited myocarditis presenting with chest pain and ST segment elevation in adolescents after vaccination with the BNT162b2 mRNA vaccine". This reporter reported 2 reports; this is the 2 of 2 reports. We describe, for the first time, adolescents presenting with chest pain and imaging evidence of myocarditis in close temporal association with the BNT162b2 vaccination. Two adolescent males, aged 15-16 years of age, presented in the Emergency Department with chest pain within 3 days of BNT162b2 vaccine administration, one of them after the first, the other (patient of this case) after the second dose of the vaccine. One patient noted mild and typical vaccine-related symptoms including tactile fever, headache, and tender vaccination site within a day of vaccine administration, while the other patient (patient of this case) had no such symptoms. Within a couple of days after vaccination, both patients developed acute onset, mid-sternal, non-radiating chest pain associated with chest tightness. One patient (not patient of this case) had a history of mild intermittent asthma, otherwise, they had no known medical conditions and no prior surgeries. Their initial vital signs were notable for sinus tachycardia with heart rate of 108-116 beats per minute, but normal blood pressure. They had a normal cardiac exam without a murmur or friction rub. Inflammatory markers were mildly elevated (Table 1). Complete blood count was notable for neutrophilia without leukocytosis. Cardiac enzymes were elevated in both cases at presentation (Table 1). Infectious workup including immunoglobulin G and real-time reverse transcription polymerase chain reaction for SARS-CoV-2 and respiratory viral panel polymerase chain reaction containing the most common aetiologic agents of viral myocarditis were negative in both patients. Chest X-rays were unremarkable. Electrocardiograms showed ST elevation and T wave inversion in lateral leads (Fig 1). Both patients had normal left ventricular systolic function on echocardiogram (Table 1). Small areas of increased echogenicity could be detected throughout the myocardium in one of the patients, especially in the interventricular septum and lateral wall of the left ventricle (Fig 1). Cardiac MRI with early gadolinium enhancement using electrocardiogram- gated turbo spin echo T1-weighted sequences showed mild global early enhancement of the myocardium, with pronounced enhancement in the subendocardial layer of the left ventricle (Fig 1), findings consistent with inflammation of the myocardium without evidence of myocardial necrosis, fibrosis, or oedema. Cardiac catheterisation was not performed as there was low suspicion for acute coronary syndrome and the cardiac MRI was consistent with myocarditis. One patient received intravenous immunoglobulin, while the other patient (patient in this case) improved without any treatment. Echocardiograms continued to show normal left ventricular function throughout the hospitalisation. Troponin T peaked at 832 and 1210 ng/L, but creatine kinase myocardial band did not increase beyond initial levels (Table 1). Chest pain resolved a day after admission and both patients were discharged from the hospital within 4 days of admission. Electrocardiograms showed improved, but continued mild ST segment elevation at discharge. Discussion: We present two adolescents with evidence of myocarditis shortly after BNT162b2 vaccination. The presentation of these adolescents were consistent with myocarditis based on clinical, imaging, and laboratory findings, and no other alternative aetiology was found. We excluded acute or recent COVID-19 infection and did not find evidence of other viral aetiologies. The temporal association with the preceding COVID-19 vaccine raised the suspicion of a vaccinerelated self-limited myocarditis. Our case series suggests that chest pain within a week of COVID- 19 vaccination with an mRNA vaccine should raise the suspicion of focal myocarditis. Table 1. Demographics, clinical findings, and diagnostic test results of the patients with myocarditis following BNT162b2 vaccine administration: Patient B: Demographics: Age, years: 16; Sex Male; Ethnicity/race:[redacted]; History of cardiac conditions: None; BNT162b2 vaccine: Number of doses given: 2; Days after last vaccine administration to onset of chest pain: 2; Vital signs at presentation: Heart rate, beats per minute: 108; Blood pressure, mmHg: 131/91; Temperature, degree celsius: 37.2; Respiratory rate: 20; SpO2 in room air, %: 100; Cardiac markers (normal range): Troponin T, ng/L (<20 ng/L): At presentation: 431, Peak: 1210; CKMB, U/L (<4.1 U/L): At presentation: 39.3, Peak: 39.3; NT-proBNP, pg/mL (0-125 pg/mL): At presentation: 325, Peak: 364; Other laboratory results (normal range): ESR, mm/hr (0-15 mm/hr): 31; Procalcitonin (<0.10 ng/mL): <0.06; CRP, mg/L (<5.0 mg/L): 24.3; SARS-CoV-2 RT-PCR: Negative; SARS-CoV-2 IgG (<1.40 index): Negative (0.03); Respiratory viral panel PCR: Negative; Electrocardiogram findings: ST segment elevation in inferolateral leads, T wave inversion; Echocardiogram findings: LVEF 60%; Cardiac MRI findings: Early gadolinium enhancement (4 minutes) of the myocardium. Figure 1. Electrocardiogram, echocardiogram, and cardiac MRI findings associated with myocarditis after BNT162b2 vaccination. (a) Electrocardiogram shows ST segment elevation, especially in the lateral leads. (b) The echocardiogram shows patchy echogenic foci in the left ventricle with intact left ventricular systolic function. Arrow indicates echogenic areas in the interventricular septum. (c) Cardiac MRI with gadolinium enhancement using electrocardiogram-gated turbo spin echo T1-weighted sequences demonstrates early enhancement of the myocardium of the left ventricle, especially in the subendocardial layer, but no necrosis or significant oedema, consistent with myocarditis. Arrow indicates bright, enhanced areas of the left ventricular myocardium. Insert shows pre-gadolinium image with no myocardial enhancement. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocarditis due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021881859 same article, product, different patient, event

Other Meds:

Current Illness:

ID: 1497535
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: A lot of pain/horrible body aches; can barely move; This is a spontaneous report from a contactable consumer and patient (non-contactable). This patient of an unspecified age and gender reported that the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and no adverse event reported for it. Reportedly, the patient wondered that has anyone experienced horrible body aches with their second covid vaccine (Pfizer), and if so, how long did it last. The patient got his on Tuesday and the patient was still dealing with a lot of pain (unspecified date) and can barely move today (unspecified date). But the patient was glad that the patient had vaccine. Event took place after use of product. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1497536
Sex: U
Age:
State: DE

Vax Date: 02/02/2021
Onset Date: 07/04/2021
Rec V Date: 07/23/2021
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: On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); On July 4th I believe I contracted covid 19. I have been quite sick (high fever, chills, cough, respiratory symptoms); This is a spontaneous report from a Pfizer sponsored program COVAX US support. A 28-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 02Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient received vaccine in Jan2021 and was fully vaccinated 02Feb2021. The patient was so excited and so grateful for the vaccine and protection. On 04Jul2021, the patient believe he/she contracted covid 19. The patient has been quite sick (high fever, chills, cough, respiratory symptoms). The patient was also 28 and in good health. Hopefully the patient's story could push for a booster to the vaccine for others and myself. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497537
Sex: F
Age:
State: CA

Vax Date: 03/06/2021
Onset Date: 03/01/2021
Rec V Date: 07/23/2021
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: she was exhausted for an entire week/She generally felt fatigued; She felt very weak/ She had no energy; She was not feeling great for about 7-10 days; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EU6199, Expiry date: not reported), via an unspecified route of administration on 06Mar2021 (age at the time of vaccination was 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history included seasonal allergy from an unknown date and unknown if ongoing , sinus disorder from an unknown date and unknown if ongoing , hay fever, pet dander and pollen allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not administer any other vaccines on same date of Pfizer vaccine and did not receive any other vaccinations within 4 weeks of Pfizer vaccination. On an unknown date in Mar2021, after the first vaccination the patient was exhausted for an entire week. The patient felt very weak, had no energy, and generally felt fatigued and was not feeling great for about 7-10 days. The patient recuperated from her first COVID-19 Vaccine dose. The patient received a corrective therapy for all the events. The patient visited emergency room/ physician office visit due to the events. The patient underwent lab tests and procedures which included chest x-ray and result was normal on an unknown date Jan2020, oxygen saturation: always in the 90s on an unknown date in 2021. The outcome of all events was recovered on an unknown date in 2021.

Other Meds:

Current Illness:

ID: 1497538
Sex: F
Age:
State: NY

Vax Date: 05/06/2021
Onset Date: 05/08/2021
Rec V Date: 07/23/2021
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: burning on bottom of feet, bottom of hands; pins and needles; numbness on tongue; electric impulses on the top of her toes; tongue she has had burning; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- EWO176, expiration date was unknown) via an unspecified route of administration, in left arm upper shoulder, on 06May2021, (at the age of 61-year-old), dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her first shot on 06May2021 and ended up not getting the second because she had weird reactions that have not went away. On 08May2021, patient had burning on bottom of feet, bottom of hands; hands have gotten better and her feet no, pins and needles; it's still there every day, it's persisting; numbness on tongue, also got electric impulses on the top of her toes. Patient clarified that, she has had numbness, pins, and needles, burning on both her hands and feet. On her tongue she has had burning, pins and needles. Her tongue was consistent. Patient called to her internist and he said maybe she shouldn't get the second dose because it sounded like an allergic reaction. No additional vaccines administered on same date of the Pfizer suspect. No other vaccine prior vaccinations within 4 weeks. Patient did not require a visit to emergency room and physician office. Patient did not receive any treatment to the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1497539
Sex: F
Age:
State: CA

Vax Date: 04/03/2021
Onset Date: 04/01/2021
Rec V Date: 07/23/2021
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: SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, Not Feeling Great) was reported as worsened.; SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, Not Feeling Great) was reported as worsened.; SECOND DOSE: the same symptoms happened again (Exhausted, Very Weak, No Energy, Generally Fatigued, Not Feeling Great); SECOND DOSE: her chest organs, primarily her lungs, felt hot or like they were on fire in her body./ also had pain in the front (chest area); SECOND DOSE: She periodically had severe back pain in the location of her lungs, and also had pain in the front (chest area); SECOND DOSE: She was having a hard time breathing; SECOND DOSE: her heart felt like it was racing; SECOND DOSE: she had a dry cough all day long; SECOND DOSE: She felt nauseous; SECOND DOSE: She felt panicked; Felt really crapy, and would have to lay down a lot; She felt so sick; Her chest felt like she couldn't catch her breath, and then it got a little worse and now it's all day long.; She had a chest infection; drug ineffective; Reported she had all COVID-y things.; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: ER8736), via an unspecified route of administration on 03Apr2021 as dose 1 single for covid-19 immunisation. Historical vaccine was BNT162B2(CONMINTARY, Solution for injection, Lot No: EU6199), via an unspecified route of administration on 06Mar2021 as dose 1 single for covid-19 immunisation. Medical history included seasonal allergy from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, sinus disorder from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, seasonal allergy from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, allergy to animal from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, seasonal allergy from an unknown date and unknown if ongoing She had sinus problems, and her whole life had seasonal allergies (clarified as hay fever, pet dander, and pollen). No further details provided, non-tobacco user from an unknown date and unknown if ongoing. There were no concomitant medications. On unspecified date in Apr2021, the patient was exhausted, very weak, no energy, generally fatigued, not feeling great) was reported as worsened, from the second dose the same symptoms happened again. On an unspecified date in 2021, the patient experienced she had a chest infection, second dose her chest organs, primarily her lungs, felt hot or like they were on fire in her body/ also had pain in the front, second dose she periodically had severe back pain in the location of her lungs, and also had pain in the front, second dose she was having a hard time breathing, second dose her heart felt like it was racing, second dose: she had a dry cough all day long, second dose: she felt nauseous, second dose: she felt panicked, felt really crapy, and would have to lay down a lot, she felt so sick, her chest felt like she couldn't catch her breath, and then it got a little worse and now it's all day long and reported she had all COVID-y things. The patient underwent lab tests and procedures which included biopsy lung: granulomas were clusters of inflamed cells on 2021, biopsy lymph gland: negative on 2021, blood test: negative on, chest x-ray: normal on Jan2020, chest x-ray abnormal: granuloma in both lungs on 2021, laboratory test normal: every test performed was negative on 2021, oxygen saturation: oxygen levels were always in the 90s on 2021 She was never short of oxygen, positron emission tomogram abnormal: lymph nodes throughout her body were "lit" on Jun2021. Therapeutic measures were taken as a result of she had a chest infection, second dose: the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great) was reported as worsened, second dose: the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great) was reported as worsened, second dose: the same symptoms happened again (exhausted, very weak, no energy, generally fatigued, not feeling great), second dose: her chest organs, primarily her lungs, felt hot or like they were on fire in her body./ also had pain in the front, second dose: she periodically had severe back pain in the location of her lungs, and also had pain in the front, second dose: she was having a hard time breathing, second dose: her heart felt like it was racing, second dose: she had a dry cough all day long, second dose: she felt nauseous, second dose: she felt panicked, she felt so sick, her chest felt like she couldn't catch her breath, and then it got a little worse and now it's all day long. Patient stated she wanted to report many adverse reactions she had to the COVID-19 Vaccine and reported her adverse reactions to the CDC a couple months ago through VAERS and HCP declined to provide reported she had her first COVID-19 Vaccine dose in Apr2021 and approximately 6 weeks later had her second COVID-19 Vaccine dose in May2021. Reported she didn't have a typical reaction to the COVID-19 Vaccine. After her first COVID-19 Vaccine dose, she was exhausted for an entire week. She felt very weak, had no energy, and generally felt fatigued and was not feeling great for about 7-10 days. She recuperated from her first COVID-19 Vaccine dose. She got the second COVID-19 Vaccine dose, and the same symptoms happened again. She didn't get a fever after either vaccine dose, but felt really crapy, and would have to lay down a lot. She said she normally walked every day and was the type of person who was always busy doing something. She said it was not normal for her to have to lay down. Reported after her second COVID-19 Vaccine, she had a chest infection, and a cough that wouldn't go away. She went to an Urgent Care for her cough. She said the healthcare provider at the Urgent Care was not sure what was going on and sent her to a pulmonologist. Treatment was the pulmonologist prescribed antibiotics (she clarified she did not know the name of the antibiotics, nor have the NDC, Lot, and Expiry Date), and ordered a chest x-ray. The chest x-ray showed her lungs were peppered with granuloma. She said she never smoked, and no one in her family ever had that type of cancer. She had a chest x-ray in Jan2020 that was normal, clarifying the chest x-ray showing the granuloma in her lungs was done in late May2021 or early Jun2021. The pulmonologist first told her the recent chest x-ray results were nothing big, but then the pulmonologist said the radiologist (who read her chest x-ray) was very concerned, and suggested she have a PET Scan. Her PET Scan showed all her lymph nodes throughout her body, but primarily in her thorax, were Lit. Reported she felt so sick, and was having a hard time breathing, but when she checked her oxygen with a pulse oximeter, she was never short of oxygen. She clarified her oxygen levels were always in the 90s. She felt like she had smog in her lungs while swimming in a pool. She felt like she had a hard time catching her breath and had to sit down. Reported she was putting everything together now. She didn't know what was going on at first. Reported the pulmonologist ran every test that could be ran, and all the tests were negative. No further details provided. Reported the pulmonologist wanted to do a bronchoscopy, and a lavage in her oesophagus. She said she never had a bronchoscopy and lavage done before. She had a biopsy of her lung granulomas, and the biopsy showed the granulomas were clusters

Other Meds:

Current Illness:

ID: 1497540
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Has a terrible itchy red rash after getting the second dose; This is a spontaneous report from a Pfizer Sponsored Program via non-contactable consumer or other non hcp (Patient's daughter). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date the patient experienced a terrible itchy red rash after getting the second dose of the covid vaccine and was still experiencing these side effects. Event was non-serious, and the outcome was not recovered. No follow-up attempts are possible. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1497541
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; The callers wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized.; Caller states his wife is in the hospital she is that bad; Sick; Nauseous; This is a spontaneous report from a contactable consumer (spouse). A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported stated, his wife also was diagnosed with Covid after receiving her first vaccine and is currently hospitalized. Reporter wanted to know what he should do about receiving the second Pfizer Covid 19 Vaccine. Again stated, his wife was in the hospital she was that bad. Stated he does not think that answering questions for a report would be helpful. Stated he got it because an unfortunate person had it and gave it to him and his wife. Reporter stated what he was concerned with now, she was in the hospital and he was at home and feels better and it has been at least 10-14 days, he figures he can he get the shot, but he wants to see what he should do about the second dose. Reporter stated the same thing happened with his wife and it hit. Stated it was not the next day but they felt nauseous and sick, not the day after but a few days after, probably a week or so before someone gave them a push. Stated he does not wish to complete any reports at this time, he does not feel that it would help anything. The events were assessed as serious and caused/prolonged hospitalization. The patient underwent lab tests and procedures which included diagnosed with Covid: positive on an unspecified date. The outcome of events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021881074 same reporter/drug/AE , different patient.

Other Meds:

Current Illness:

ID: 1497542
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
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: her husband got sick from the vaccine; This is a spontaneous report from a contactable consumer (patient wife) via Medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunisation. The patient medical history and concomitant medications were not reported. Caller states her husband got sick from the vaccine on an unspecified date, but she had nothing besides the side effect on her arm. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497543
Sex: U
Age:
State: CA

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 07/23/2021
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: I am barely unable to get out of bed due to severe chest pains; I am barely unable to get out of bed due to severe chest pains; This is a spontaneous report from a contactable consumer or other non hcp. Pfizer sponsored program. A consumer (patient) reported that a 31-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date May2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. On an unspecified date 2021 the patient experienced a major reaction to the second Pfizer vaccine received 8 weeks ago and after 11 visits to 8 different doctors offices, patient finally know what was going on and patient wanted to make sure that they were aware so that they could be more pro-active in helping patients who are suffering. Despite being a health nut, active 31y with no previous conditions, patient was barely unable to get out of bed due to severe chest pains on an unspecified date in 2021. The events resulted in physician office visit. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497544
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 07/23/2021
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: her blood pressure, it was a little bit high; little bit shortness of breath; she felt not well; a little bit tired; a fast pulse; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jun2021 as single dose (at age of 80-years old) for COVID-19 immunization. The patient medical history include she still did not see doctor but the last time she saw a doctor was years ago when her husband was in critical condition, for anxiety, and he passed away she still has anxiety off and on. The patient concomitant medications were not reported. The patient had the Pfizer vaccine three weeks ago (Jun2021) and tomorrow (13Jul2021) will be the second shot that she supposed to take, but today (12Jul2021) and during the first week it was fine. she states before she took the first one, and her blood pressure was perfect, she did it twice, but after that, a week later (Jun2021), she felt a little bit tired and fast pulse and it was going on for about a week and she felt not well. She states now she feels better, and she goes to have another shot tomorrow. States on 12Jul2021 (today), she took her blood pressure, and it was a little bit high. It was 144/72 and 71 and sometimes, it came down to 142 so she wondered if it was okay if she comes tomorrow for another shot. She states her doctor was not available, so she wonders if its because of the blood pressure machine, but she did it three times. it was 144/77, 63 and then it came down to 143/71, 72 so was it okay for her to come tomorrow. She did have a little bit shortness of breath for the second week (Jun2021). She wants to know that it was okay if she comes back tomorrow with a little high blood pressure like that she states but tomorrow, it will be her appointment for her second shot and the question was if she could come tomorrow for another shot with a little bit high blood pressure like that because she afraid that the side effect of the second time will be worse than the first one. Caller states she's short and this was not that serious of a reaction because she still keeps on doing her daily tasks, she walks, and jogging around, but with a little bit shortness of breath for the 2nd week in the beginning and a couple days later, and now its coming down, and today she feels good. The outcome of events a little bit tired, a fast pulse, her blood pressure, it was a little bit high and little bit shortness of breath was unknown and the outcome of event she felt not well was resolved on unknown Jul2021. Information regarding the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497545
Sex: F
Age:
State: MO

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 07/23/2021
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: Blurry and double vision in left eye; Blurry and double vision in left eye; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration date not reported), via an unspecified route of administration, administered in arm Left on 25Mar2021 (at the age of 44-year-old) as a single dose, and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730, Expiration date not reported), via an unspecified route of administration, administered in Arm Left on 25Mar2021 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation at Doctor's office/urgent care. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 25Mar2021, the patient had inappropriate schedule of vaccine administered. On 02May2021 19:00, the patient experienced blurry and double vision in left eye. It was reported that the patient saw an ophthalmologist but could not correct. Ophthalmologist cannot get my vision to 20/20 with any lens at all. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. On an unspecified date in 2021, the patient underwent lab tests and procedures which included eye test: cannot get my vision (Ophthalmologist cannot get my vision to 20/20 with any lens at all). The seriousness of the events was reported as non-serious. Therapeutic measures were taken as a result of blurry and double vision in left eye. The outcome of event blurry and double vision in left eye was not resolved and the outcome of inappropriate schedule of vaccine administered was unknown. Device Date was reported as 12Jul2021. Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1497546
Sex: M
Age:
State: AK

Vax Date: 06/10/2021
Onset Date: 06/13/2021
Rec V Date: 07/23/2021
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: Myocardium/pounding heart episodes started 3 days after second dose; Reaction and illness lasted one week; This is a spontaneous report from a contactable consumer (patient, self-reported). A 70-year-old male patient 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, in Arm Right, on 10Jun2021 at 14:30 PM (age at vaccination: 70 years), as a single dose for COVID-19 immunization at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. 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, in Arm Right, on an unspecified date in 2021 at 02:30 PM (age at vaccination: 70 years), as a single dose for COVID-19 immunization at pharmacy or drug store. The patient reported that on 13Jun2021 at 03:30 PM, he experienced myocardium/pounding heart episodes started 3 days after second dose and reaction and illness lasted one week. The patient did not receive treatment for the adverse event. Outcome of the events was recovering. Information regarding the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497547
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Got sore on her arm; This is a spontaneous report from contactable consumer (patient's spouse) received from a Pfizer sponsored program. A female patient of an unspecified age received dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that "About the medication Celebrex being removed from the Patient assistance program. During the call caller stated the following about their experience with The Pfizer-BioNTech COVID-19 vaccine. The caller stated that My wife and I both we took the COVID shot both of them it was through Pfizer. We did not had no side effects my wife it kind of got sore on her arm on unknown date, but it was just like nothing on me I did not feel nothing". The outcome of the event was reported as unknown. Note: The patient's first and last name and date of birth was not provided during the call. The following information was not confirmed during the call, but retrieved from the system: Patient DOB. Information about lot/Batch number has been requested

Other Meds:

Current Illness:

ID: 1497548
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 04/21/2021
Rec V Date: 07/23/2021
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: Hypothyroidism; Loss of hearing in my left ear; autoimmune flair up; Injection site pain; muscle ache; Fever; Fatigue; Dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734) dose 1 via an unspecified route of administration, administered in arm right on 2021 12:00 PM and dose 2 via an unspecified route of administration, administered in arm left on 2021 (Batch/Lot Number: Er8736) both as single dose for covid-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID) 100 mcg. Patient had no allergies. Patient was not pregnant at the time of vaccination. Patent did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. In 2021, dose 1 administered in 2021 12:00 PM and dose 2 administered in 2021 also. On 21Apr2021 22:00, the patient experienced hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. These events resulted in doctor or other healthcare professional office/clinic visit. SYNTHROID dose was increased, and blood work (date and result: not reported) was performed to treat the adverse events of hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue. The outcome of events hypothyroidism, autoimmune flair up, loss of hearing in her left ear, injection site pain, muscle ache, fever, and fatigue were recovering.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Hypothyroidism, condition aggravated, Unilateral deafness and suspect drug 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: SYNTHROID

Current Illness:

ID: 1497549
Sex: M
Age:
State: PA

Vax Date: 01/20/2021
Onset Date: 06/01/2021
Rec V Date: 07/23/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Transverse Myelitis; This is a spontaneous report from a contactable pharmacist. A 40-years-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El3249) via an intramuscular route of administration in Arm Right on 20Jan2021 03:15 (age at vaccination 40years old) as Dose 2,Single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, HTN, hyperlipidaemia from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine was administered in Workplace clinic. Concomitant medication(s) included semaglutide (OZEMPIC); metformin (METFORMIN); hydrochlorothiazide, losartan potassium (HYZAAR); rosuvastatin calcium (CRESTOR). All taken for an unspecified indication, start and stop date were not reported. The patient was allergic to the drug Amoxil.Since the vaccination, the patient had not been tested positive for COVID-19. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El0142) via an intramuscular route of administration in Arm Right on 30Dec2020 03:15 as Dose 1,Single for COVID-19 immunization. The patient experienced transverse myelitis in Jun2021. The patient was hospitalized for transverse myelitis for 3 days. The patient received any treatment for the adverse events. Therapeutic measures were taken as a result of transverse myelitis. The clinical outcome of the event recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug 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: OZEMPIC; METFORMIN; HYZAAR; CRESTOR

Current Illness:

ID: 1497550
Sex: M
Age:
State: OH

Vax Date: 05/15/2021
Onset Date: 06/16/2021
Rec V Date: 07/23/2021
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: typical Guillain-Barre syndrome; he could not walk; he cannot play any sport because he cant run/ no control from his waist down; he needed a catheter ,he was not able to pee or poop; he needed a catheter ,he was not able to pee or poop; This is a spontaneous report from a contactable consumer (parent). A 14-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0179; Expiration Date: 31Aug2021; NDC number and UPC number: unknown) via intramuscular on 15May2021 (at the age of 14-years-old) in left arm (shoulder) as a DOSE 1, SINGLE for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0182; Expiration Date: 31Aug2021; NDC number and UPC number: unknown) via intramuscular on 05Jun2021 (at the age of 14-years-old) in left arm (shoulder) as DOSE 2, SINGLE for covid-19 immunization. Medical history included papilloma viral infection from 06May2021 to 06May2021 and bowel movement irregularity from an unknown date and unknown if ongoing. The report was not related to a study or programme. Prior vaccinations (within 4 weeks) included HPV (human papilloma virus) vaccine on 06May2021. Concomitant medication included macrogol 3350 (MIRALAX) as he had trouble going to the bathroom because he didn't had control and had trouble with bowel movement, he started when he left the hospital, so he can get back to his bowel, but he stopped using it couple of days ago as he started to go to the bathroom on his own again. The patient received both doses of Pfizer covid vaccine. He had a serious reaction to the vaccine, he couldn't go to the bathroom on his own, he had no control from his waist down, he needed a catheter as he was not able to pee or poop. He was admitted to the emergency room on 16Jun2021 and spent 3 days in the ICU because he could not walk and move, spent 3 days in out the down rated version, total 6 days in the hospital. He was diagnosed with Guillain-Barre syndrome and he was in the hospital on his birthday in Jun2021 and was doing physical therapy to walk and run again. His mother was trying to deal with the covid compensation because they had work. She and her husband were alone in the hospital. She reported that their medical bills were going to be crazy because they had to go by ambulance from one hospital to other because they were afraid of Guillain-Barre syndrome. The patient didn't have any movement in his legs all the way up to his heart. He was not able to play any sport because he can't run. The patient was discharged from the hospital and was on physical therapy (water therapy). The patient underwent lab tests and procedures which included two MRI, spinal test, and blood work with unknown results in the emergency room as they weren't sure what was going on with him. The patient was treated with IVIG and blood thinner everyday two times a day. The outcome of all the events were unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: MIRALAX

Current Illness:

ID: 1497551
Sex: F
Age:
State: CA

Vax Date: 06/23/2021
Onset Date: 06/23/2021
Rec V Date: 07/23/2021
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: Rapid heartbeat; Blood pressure dropped; It was even in the 80 over 50; This is a spontaneous report from a contactable Nurse (patient). An 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Left upper arm on 23Jun2021 (at the age of 81-years-old) (Batch/Lot Number: EW0180) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient did not receive any prior vaccination (within 4 weeks). The patient reported that she had it on the 23rd and that evening, she started experiencing very rapid heartbeat and then her blood pressure dropped, it took almost two weeks to bring her blood pressure, where it was even in the 80 over 50. When asked about treatment received, patient stated that no, she had to do it herself, her son is quadriplegic (further clarification unknown) and she couldn't leave him by himself. Patient stated causality, "Yes." (not clarified further by appropriately paraphrasing events, hence causality tab left unchecked). Outcome of the event rapid heartbeat was unknown, blood pressure dropped was recovered in Jul2021. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1497552
Sex: F
Age:
State: LA

Vax Date: 02/01/2021
Onset Date: 06/26/2021
Rec V Date: 07/23/2021
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: Got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and got diagnosed with Covid 19 on 26Jun2021; Got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and got diagnosed with Covid 19 on 26Jun2021; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration on Feb2021, dose number unknown, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and she got diagnosed with Covid 19 on 26Jun2021. The reporter further mentioned that her whole family was vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and her parents were also diagnosed with Covid 19 on the same day. MD said them that they had the virus breakthrough and she mentioned that it seems to be happening to many people. On 26Jun2021, the patient underwent lab tests and procedures which included being diagnosed with Covid 19 (sars-cov-2 test was positive). The outcome of the event was unknown. Follow up needed, further information about Lot/Batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884586 Same reporter/drug/AE, different patient.;US-PFIZER INC-2021884585 Same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1497553
Sex: M
Age:
State: LA

Vax Date: 02/01/2021
Onset Date: 06/26/2021
Rec V Date: 07/23/2021
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: I got diagnosed with Covid 19 on June 26,2021. My parents were diagnosed with Covid 19 on the same day.; I got diagnosed with Covid 19 on June 26,2021. My parents were diagnosed with Covid 19 on the same day.; This is a spontaneous report from a Pfizer sponsored program Pfizer. This consumer reported for a male patient (reporter's father) that, A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter said that, my whole family is vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and I got diagnosed with Covid 19 on 26Jun2021. My parents were diagnosed with Covid 19 on the same day. MD said we had the virus breakthrough. It seems to be happening to many people. Outcome of unknown The patient underwent lab tests and procedures which included sars-cov-2 test which was, positive on 26Jun2021 (got diagnosed with Covid 19 on 26Jun2021). Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884456 Same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1497554
Sex: F
Age:
State: LA

Vax Date: 02/01/2021
Onset Date: 06/26/2021
Rec V Date: 07/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: I got diagnosed with Covid 19 on 26Jun2021. My parents were diagnosed with Covid 19 on the same day.; I got diagnosed with Covid 19 on 26Jun2021. My parents were diagnosed with Covid 19 on the same day.; This is a spontaneous report from a Pfizer sponsored program. This consumer for a female patient (reporters mother) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced i got diagnosed with covid 19 on 26jun2021, my parents were diagnosed with covid 19 on the same day. It was reported that his whole family was vaccinated with the Covid 19 vaccine by Pfizer since Feb2021. MD says we had the virus breakthrough. It seemed to be happened to many people in the (with held) and just wanted you to be aware. The patient underwent lab tests and procedures which included COVID-19: positive, got diagnosed with Covid 19 on 26Jun2021. Events were considered serious (medically significant). The clinical outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884456 Same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1497555
Sex: M
Age:
State: NY

Vax Date: 03/27/2021
Onset Date: 04/11/2021
Rec V Date: 07/23/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of April.; his pulse is starting to slow; They did the TSI test on the patient and noticed an extreme increase; having thyroid issues; blood sugar was dropping; The caller's symptoms went from being mild to very acute.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; The caller's T3 and T4 were extremely high and his TSH was extremely low.; Palpitations/extreme palpitation in his chest and aorta that would pulsate; Weight loss; Sinus pain; Eye irritation; restlessness at night; extreme nausea; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 2, single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, he was diagnosed from 4 years (in 2017). The patient no other products taken. Prior to March the patient had no problem (before vaccination). About 2 weeks after the second dose of the vaccine on 11Apr2021, the patient had extreme nausea, palpitations, baseline heart rate was over 105 and lost 40 pounds. Patient also started having sinus pain and eye irritation, and restlessness at night and started waking up very early. The caller had a weight loss of 8 pounds for the month of April without changing his lifestyle. Patient had a slow increase in his heart rate from 60 to about 80 in the month of April. Towards the beginning of May the patient had loss of appetite and he would get tired very quickly. When it all hit the patient at once it was around May202, he started spiking fevers, nausea, extreme palpitation in his chest and aorta that would pulsate, and increased blood pressure. The patient went and saw his doctor and checked his thyroid levels that were normal nearly 6 months prior. The patient's T3 and T4 were extremely high and his TSH was extremely low. They did the TSI test on the patient and noticed an extreme increase and then diagnosed him with Grave's disease. The patient did all of the scans. The patient was hospitalized for nearly 6 days because they put him on methylprednisolone and had a toxic effect on his system. The caller's white blood cells came down, it attacked his bone marrow, his liver panel showed issues. The caller was hospitalized on 27Jun2021 to 02Jul2021 for this. The patient had never had any indications of having thyroid issues or Grave's disease prior to this event. The patient's symptoms went from being mild to very acute. The patient was weak right now (at the time of report) because of the weight loss, his pulse was starting to slow and still has palpitations and his nausea was still there and lots of diarrhea. Everything had worsened until now that he had sought treatment (at the time of report). The patient's blood sugar was dropping during this time and had an A1C of 6. The patient underwent lab tests and procedures which included blood sugar was dropping during this time and had an A1C of 6: positive on 07Jul2021, TSH (thyroid stimulating hormone): .008 on 07Jul2021, radioactive iodine uptake assays: show diffuse uptakes of the radioactive tracers and is consistent with Grace's disease on 07Jul2021, 08Jul2021 and 09Jul2021, free thyroxine: >30 on 07Jul2021, T3 (tri-iodothyronine): >8 on 07Jul2021, Free T3 (tri-iodothyronine free): > 32.6 on 07Jul2021, patient's CBC and platelets were in the normal range. Outcome of the event grave's disease was resolving; weak, diarrhea and pulse was starting to slow was unknown and outcome of rest of the events was not resolved. Follow-up attempts are needed. further information is expected.

Other Meds:

Current Illness:

ID: 1497556
Sex: F
Age:
State: IL

Vax Date: 06/21/2021
Onset Date:
Rec V Date: 07/23/2021
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: Today will be the 21th day of his schedule, she would be receiving the second dose technically but his wife does not have any idea about the second dose; His wife was bedridden; This is a spontaneous report from a contactable consumer or other non hcp Pfizer sponsored Program. A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 21Jun2021 as 2nddose, single for covid-19 immunisation. Historical vaccine was BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced today will be the 21th day of his schedule, she would be receiving the second dose technically but his wife does not have any idea about the second dose on an unspecified date with outcome of unknown, his wife was bedridden on an unspecified date Yes, it is covid-19 vaccine a pfizer product and unspecified about the covid-19 vaccine manufacturer, start and stop dates for covid-19 vaccine was unspecified, NDC and UPC number of Covid-19 vaccine was unknown, patient was unwilling to complete the report was the reason for no lot number, expiry date of covid-19 Vaccine was unknown. Call was transferred from Pfizer (Name withheld) (CEP ID: 159558), transferring agent stated, "patient is calling on behalf of his wife, (Name withheld) who got the second dose last 21Jun2021. Well, he mentioned that his wife is bed ridden and someone good, come to their house administered the first dose and unfortunately while checking the vaccination card there is no information about the second dose. However, if he will be following as per with a full UN information about the 21 days, today will be the 21st day of his schedule, she would be receiving the second dose technically, but his wife does not have any idea about the second dose because no one informed them and he don't have the address or location of the facility. That is why I decided to transfer it to the Pfizer Drug Safety Department. When confirmed the concern, reporter stated, Should I wait because the lady said it might take 3 to 5 weeks, should I wait 2 more weeks to see what happens or?"(Incomplete sentence) (Further clarification unknown).Reporter was informed about the role of Pfizer Drug Safety and about Pfizer Medical Information for the concern and was provided with the contact details of Pfizer Medical Information as (Telephone number withheld) option 3, timings as 8 am to 8 pm Monday to Friday as per EST. Reporter further stated, They work 8 am to 8pm, because the lady was just the lady (Name withheld) she says they get off of work at 3 o'clock, say they work from 9 am to 3 pm. Reporter confirmed the name of the product as Pfizer Covid19 vaccine. Reporter stated, Yeah, for her second shot. All I want to know her second shot, when I am giving her second shot? reporter was confirmed that the timings of Pfizer Medical Information Department for Pfizer Covid19 vaccine are 8 am to 8 pm as per EST. Outcome of the events were unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1497557
Sex: F
Age:
State: FL

Vax Date: 05/30/2021
Onset Date:
Rec V Date: 07/23/2021
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: Yellow fluid leaking out of her hands; This is a spontaneous report from a contactable consumer or other non hcp. A 25-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0202; Expiration Date: Sep2021) via an unspecified route of administration, administered in Deltoid Left on 30May2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia from an unknown date and unknown if ongoing Verbatim: Anaemia. The patient's concomitant medications were not reported. Reporter stated, "She is not taking any with us and I am assuming she is probably just getting some Iron supplements. (Further not clarified. Hence, not captured in tab). The patient experienced yellow fluid leaking out of her hands on an unspecified date.It was reported that patient who took the first dose and she was about to get the second dose today. But she said that during the first dose when she received this, she had an adverse event which was there is a yellow fluid leaking out of her hands. The outcome of the event discharge was recovering. No follow-up attempts are needed. No further information was expected.

Other Meds:

Current Illness:

ID: 1497558
Sex: M
Age:
State: PA

Vax Date: 04/08/2021
Onset Date: 04/11/2021
Rec V Date: 07/23/2021
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: I was fully vaccinated with Pfizer vaccine back in April and I got positive with covid 2 weeks ago.; I was fully vaccinated with Pfizer vaccine back in April and I got positive with covid 2 weeks ago.; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EP7534) via an intramuscular route of administration in left arm on 16Mar2021 (age at vaccination 25-year-old) as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0153; Expiration Date: 31Jul2021) via an intramuscular route of administration in left arm on 08Apr2021 (age at vaccination 25-year-old) as dose 2, single for Covid -19 immunization. Patient medical history was not provided. Patient concomitant medications were none. Patient was fully vaccinated with Pfizer vaccine back in April and on 11Apr2021 patient got positive with covid. Patient did not receive any treatment for covid because he had pretty minor symptoms, so he did not take any medicines. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021. Product quality group provided investigation results: Description of complaint: tested positive for COVID-19 on 11Apr2021 after receiving both doses of Pfizer COVID-19 vaccine on 16Mar2021 and 08Apr2021. Additional lot numbers: EP7534 and EW0153. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0153 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. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events was unknown. 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