VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 0993840
Sex: F
Age:
State: CA

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 02/02/2021
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: Fever; Chills; This is a spontaneous report from a contactable nurse (reporting for herself). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE). The patient stated, "I think I am having the side effects, I am having some fever and chills and I had it early yesterday morning." No treatment was received for the events.The outcome of the events was unknown.

Other Meds: AMLODIPINE

Current Illness:

ID: 0993841
Sex: F
Age:
State: IN

Vax Date: 01/15/2021
Onset Date: 01/18/2021
Rec V Date: 02/02/2021
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: Developed hives on my torso; Itching; Rash on my legs; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date not reported), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal, Sjogren's which gave her dry skin. The patient was vaccinated at a clinic. Concomitant medications included lisinopril for blood pressure abnormal and furosemide as diuretic for polyuria. On 18Jan2021, the patient developed hives on her torso, itching and rash on her legs. Therapeutic measure was taken as a result of the events that included antihistamine Benadryl. Clinical outcome of the events was not recovered.

Other Meds: LISINOPRIL; FUROSEMIDE

Current Illness:

ID: 0993842
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Episode of like a sleep paralysis; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced episode of like a sleep paralysis on an unspecified date. Nurse stated, "I am a Nurse, I am going today to get my second, my booster for the Pfizer vaccine. And last time I went to get my booster, they turned me away because I had side effects and I'd told them that. I otherwise felt fine besides having like episode of like a sleep paralysis. And they freaked out and they wanted me to contact you guys to make sure that it is okay. So, they rescheduled me for today. And I send my, I did that online, like my COVID checking thing and I told them about my symptoms but I haven't been contacted by anybody. So, I just wanted to call to be sure before I go for the second COVID Vaccine." The outcome of the event was unknown. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993843
Sex: F
Age:
State: PA

Vax Date: 12/22/2020
Onset Date:
Rec V Date: 02/02/2021
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: low grade fever; myalgia; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 22Dec2020 at a single dose on left deltoid for COVID-19 immunization. Medical history included asthma exercise induced. There were no concomitant medications. The patient experienced low grade fever and myalgia on unspecified date. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993844
Sex: M
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: I woke and wasn't feeling good at all; Chills; My throat is little swollen and I have cough; My throat is little swollen and I have cough; This is a spontaneous report from a contactable consumer reporting for himself. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the next day after receiving the vaccination, the patient woke up and wasn't feeling good at all and had chills. On an unknown date, the patient reported that his throat was a little swollen and he has a cough. The patient received treatment for the events cough and throat swelling which included ibuprofen and oral septic for his throat. The outcome of the events wasn't feeling good at all and chills was not recovered. The outcome of the events throat is a little swollen and cough was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 0993845
Sex: F
Age:
State: MI

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: Experiencing like stuffy nose with her sinuses; Developed form of hive on her nose and her sinuses; feel like stuffy head; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant drugs includes levothyroxine sodium which reported as generic for Synthroid. The patient experienced like stuffy nose with her sinuses, developed form of hive on her nose and her sinuses; seems like her sinuses; she felt like stuffy head. The patient wanted to know is that a side effects or a normal reaction. Therapeutic measures were taken as a result of experiencing like stuffy nose with her sinuses includes like Tylenol. The outcome of the events was unknown.

Other Meds: LEVOTHYROXINE SODIUM

Current Illness:

ID: 0993846
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; This is a spontaneous report from a contactable consumer via Sales Representative. A patient of unspecified age and gender received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose BNT162B2 and experienced lot of arm pain. The patient experienced flu like symptoms including chills, fever, night sweats, body aches after 8 hours received vaccine. The outcome of events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0993847
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This consumer reported similar events for two patients. This is the first of two reports. A patient (reported as: healthcare professional) of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: contacted COVID after their first vaccine (medically significant). The clinical outcome of the events, drug ineffective and COVID-19, was unknown. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082538 same reporter, drugs and events.; different patient.

Other Meds:

Current Illness:

ID: 0993848
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: On my left arm bothers me it is not a pain that I cannot tolerate but it is lot more than I had first day; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (unspecified if Pfizer product), via an unspecified route of administration at left arm in Jan2021 at single dose for COVID-19 immunization. Patient had the vaccine (unspecified vaccine) on Friday on his/her left arm it didn't bother her/him that much very little. patient knew it was there, but nothing happened but after last night patient knew have like it bothers her/him it was not a pain that she/he cannot tolerate but it was lot more than she/he had first day (Jan2021). Patient was taking paracetamol (TYLENOL). Outcome of the event was unknown. Pfizer is a marketing authorization holder of COVID-19 VACCINE in the country of incident or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to the regulatory authorities. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0993849
Sex: F
Age:
State: AZ

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: an excruciating headache; This is a spontaneous from a contactable consumer (patient). This 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK9231), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included severe chronic migraine. The patient's concomitant medications were not reported. Patient stated she got her second COVID vaccine on 18Jan2021 and she has gotten an excruciating headache in Jan2021. She has taken paracetamol (TYLENOL) and 800 mg ibuprofen on 18Jan2021 and it was actually getting worse. When probed for any treatment for the problem, patient stated yes, her headache, all she had taken for 18Jan2021 so far was paracetamol, diphenhydramine hydrochloride (BENADRYL) (if might have taken for headache) and ibuprofen. Outcome of the event was unknown. No investigation assessment.

Other Meds:

Current Illness:

ID: 0993850
Sex: F
Age:
State: IN

Vax Date: 12/28/2020
Onset Date: 01/08/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the spouse of the patient. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 28Dec2020 (at the age of 62-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing lupus from an unknown date. Concomitant medications included unspecified medications for her Lupus. On 08Jan2021, the patient tested positive for COVID-19. On 18Jan2021, the patient had an X-ray with unknown results. Therapeutic measures were taken as a result of testing positive for COVID-19 and included an unspecified infusion. The clinical outcome of tested positive for COVID-19 was unknown.

Other Meds:

Current Illness:

ID: 0993851
Sex: F
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; This is a spontaneous report from a contactable nurse (patient). A 55 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142/expiration date: MAR-2021) on an unspecified date at single dose via an unspecified route of administration on deltoid Right for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported that since an unspecified date right arm, where the vaccine was given, swelled up to the soft ball size; It was a reaction, hardness, warm at the patch, redness and it kept expanding. The patient did not receive treatment for the events. At the time of the reporting events outcome was unknown.

Other Meds:

Current Illness:

ID: 0993852
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Tested positive after taking the first shot of the vaccine; Tested positive after taking the first shot of the vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A Non contactable male consumer reported that a male patient of an unspecified age received bnt162b2 (BNT162B2, Covid-19 Vaccine from Pfizer), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive after taking the first shot of the vaccine on an unspecified date with outcome of unknown. He wanted to know if he can still take the second dose. He really need to know as he had been scheduled to receive his send dose tomorrow. He really need to know whether to show up or not. The patient underwent lab tests which included sars-cov-2 test: positive on unknown date. No follow up attempts are possible. Information about Lot/ Batch could not be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.

Other Meds:

Current Illness:

ID: 0993853
Sex: F
Age:
State: IN

Vax Date: 01/11/2021
Onset Date: 01/17/2021
Rec V Date: 02/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Developed a vesicular rash; This is a spontaneous report from a contactable Other HCP. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced developed a vesicular rash on 17Jan2021, it was described as 'the patient developed a vesicular rash on day 6. This was the second vaccine. It's not a diffused drug reaction like rash, it's the vesicular'. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 0993854
Sex: M
Age:
State: OR

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 02/02/2021
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: Left eye is like somebody hit me on the eye; it is all bruise purple and black all over right between inside the corner of nose of the eye; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking cholesterol medication. Nothing special other than what you get when you get older. The patient stated that he woke up this morning (19Jan2021), his left eye was like somebody hit him on the eye. It was not the eye but above the eye. It was all bruise purple and black all over right between inside the corner of nose of the eye and all away cross the top of it. He has no idea that come from. There was no treatment for the event. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 0993855
Sex: F
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: Teeth started chattering in the middle of the night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced teeth started chattering in the middle of the night in Jan2021. The patient did not receive any treatment from event. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993856
Sex: F
Age:
State: NY

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 02/02/2021
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: Area around her mouth is a little red and it felt itchy; Area around her mouth is a little red and it felt itchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 18Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. Yesterday morning (18Jan2021) at 9:15, the patient got her vaccine, and around 04:00 PM (also reported as 04:30 PM), yesterday afternoon, the patient started to rub the area around her mouth. And when she looked it in the mirror, it was a little red and it felt itchy. The patient took diphenhydramine hydrochloride (BENADRYL) which helped a little, just one. And the patient put some diphenhydramine hydrochloride topical cream on it also. The patient was able to sleep last night and woke up this morning and the redness is gone. It's not itchy. The patient seemed to be fine, but she doesn't know if it's from the vaccine or not. It's not one of the typical side effects. The patient asked if it is safe for her to get the vaccine (second dose) or if she needs to ask them. The patient's second dose of vaccine is scheduled on 08Feb2021. The patient recovered from the events on 19Jan2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Other Meds:

Current Illness:

ID: 0993857
Sex: F
Age:
State: VA

Vax Date: 01/18/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish; Chills; Warm body; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 11:00 at single dose for covid-19 immunization. Medical history included asthma. Concomitant medication included salbutamol sulfate (PROVENTIL) for asthma. Patient previously took first dose of bnt162b2 on 30Dec2020 at single dose for covid-19 immunization. Patient got second vaccination on 18Jan2021 and may be around about 11 O'clock on same day patient felt to have a body ache all over which patient knew it was normal. However, it was getting worse throughout the day. And patient couldn't even get up and went to work. Also have very bad headache and patient blood pressure was 140/100. For about 3 hours patient did had left leg swell and caused severe pain in toes, that just subsided. Patient didn't have a fever but patient feel feverish, chills, warm body. Patient had been taking Ibuprofen on and off as treatment. Outcome of events left leg swell and caused severe pain in toes were recovering, and outcome of other events was unknown. Information about Lot/Batch number is requested.

Other Meds: PROVENTIL [SALBUTAMOL SULFATE]

Current Illness:

ID: 0993858
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Allergic reaction; She just looks all daze out; This is a spontaneous report from a contactable consumer reporting for her daughter. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history was not provided. Concomitant medication included she was on several medications (unspecified medications). On an unknown date, the patient experienced an allergic reaction and she just looks all daze out. The outcome of the events allergic reaction and she just looks all daze out was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 0993859
Sex: F
Age:
State: GA

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 02/02/2021
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: had some dragging after the first dose; This is a spontaneous report from a contactable other-HCP (Patient) A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) on 23Dec2020 at single dose intramuscular in left deltoid for COVID-19 immunization. The patient didn't have relevant medical history or concomitant drugs. Patient reported that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time (as reported). At the time of the reporting event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056967 same patient/drug, different event separated with time

Other Meds:

Current Illness:

ID: 0993860
Sex: F
Age:
State:

Vax Date: 01/17/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: soreness at the site, more soreness than after her first shot.; This is a spontaneous report from a contactable consumer reporting for a female patient (nephew's fiance). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Jan2021 as a single dose in the left arm for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. The patient previously received the first dose of BNT162B2 on 27Dec2020 and experienced soreness at the site, fatigue, and numbness in the left pinky finger (same arm as vaccination). On an unspecified date in Jan2021, the patient experienced soreness at the site, more soreness than after her first shot. The outcome of the event soreness at the site was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 0993861
Sex: M
Age:
State: TX

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 02/02/2021
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: Tightness in right side of my chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1695 or EL1695 and Expiration date 31Mar2021) on 06Jan2021 (at 48 years of age) as single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced tightness in right side of chest on an unspecified date. Patient called to see if this was a common event as patient was going to the hospital shortly to be sure nothing was wrong. Outcome of event tightness in right side of chest was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0993862
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: He felt tired and he said what he had taken; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient talked about his experience with the first and second doses, and how the second dose affected him a bit more. He did not have a temperature, but he felt tired and he said what he had taken. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0993863
Sex: M
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 02/02/2021
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: headache; some mild myalgia; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was experiencing headache and some mild myalgia post second vaccine administration today (19Jan2021). Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 0993864
Sex: F
Age:
State: NC

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 02/02/2021
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: Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 08Jan2021 at 15:30 at single dose on left deltoid/arm via an unspecified route of administration for COVID-19 immunization. Patient was instructed by head of infectious DZ Dept hospital to premedicate with Tylenol and Benadryl. On an unspecified date she experienced minor headache and sore arm, without other response to second dose. At the time of the reporting event outcome was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0993865
Sex: U
Age:
State: SD

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pericarditis; Initial information regarding an unsolicited valid serious case was received from a other healthcare professional via Agency (Reference number- 00438099) and transmitted to Sanofi on 20-Jan-2021. This case involves patient (unknown demographics) who experienced pericarditis, while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot number: UH478AC and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious pericarditis (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This event was assessed as medically significant. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. The event outcome was unknown for pericarditis.; Sender's Comments: The patient (unknown demographics) who presented with pericarditis after vaccination with FLUZONE. The time to onset is unknown. Medical history, concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon reported information role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 0993866
Sex: F
Age: 74
State: CA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/02/2021
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: none

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: arm pain at injection site & small comma rash at bottom of injection site two weeks later now have red rash area size of baseball no pain

Other Meds: none

Current Illness: none

ID: 0993867
Sex: M
Age: 42
State: IN

Vax Date: 01/30/2021
Onset Date: 01/31/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Achy body chills headache rash on neck

Other Meds: No

Current Illness: No

ID: 0993868
Sex: F
Age: 25
State: CA

Vax Date: 01/04/2021
Onset Date: 01/11/2021
Rec V Date: 02/02/2021
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: Seasonal allergies

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Moderate injection site pain followed by lymphadenopathy

Other Meds: Low-ogestrel, zyrtec

Current Illness:

ID: 0993869
Sex: F
Age: 46
State: NJ

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Nausea

Symptoms: Severe Nausea as well as a sore arm was persistent for 3 days following the injection. In addition, a rash appeared on the left side of my back and left thigh.

Other Meds: None

Current Illness: None

ID: 0993870
Sex: F
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Injection site pain

Symptoms: Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work

Other Meds: None

Current Illness: None

ID: 0993950
Sex: F
Age:
State: FL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/02/2021
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: Back side of arm has been progressively getting redder; Swollen; Painful; A big raised lump on back of her arm; Thinks she received the vaccine subcutaneously; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and thinks she received the vaccine subcutaneously, back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm. The patient's medical history was not provided. Concomitant product use was not provided. On 08 J an 2021 The patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection Lot # 012L20A. On an unknown date the patient's back of arm was progressively getting redder, swollen and painful. The pharmacist stated, "it looks like a big raised lump on back of her arm". Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The event, thinks she received the vaccine subcutaneously, was considered resolved on 08 Jan 2021. The events, back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm, was considered unknown.; Reporter's Comments: This regulatory report concerns a female patient who experienced thinks she received the vaccine subcutaneously (inappropriate route of vaccine administered), back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm. The event occurred following the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 012L20A, expiration date-unknown). Treatment administered was not reported and outcome was unknown. Based on the information provided which includes a strong temporal association and the absence of any other etiology, the events of back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm, a causal association with the vaccine administration cannot be excluded. The event of inappropriate route of vaccination is considered not applicable.

Other Meds:

Current Illness:

ID: 0993951
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: A needle went into the arm of a patient and needle fell off the syringe; A spontaneous report was received from a nurse, concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the needle went into the arm of a patient and the needle fell off the syringe There were no medical history and concomitant medications provided. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. The reporter stated that a needle went into the patient's arm and the needle fell off the syringe. Both the needle and syringe were discarded, and the patient was vaccinated with a new needle a syringe. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, a needle went into the arm of a patient and needle fell off the syringe was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection and a needle went into the arm of a patient and the needle fell off the syringe. There we no reported adverse events after the vaccine was administered in this case of syringe issue.; Sender's Comments:

Other Meds:

Current Illness:

ID: 0993952
Sex: F
Age: 52
State: FL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/02/2021
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: Got the vaccine subcutaneous/intradermaly; A spontaneous report was received from a 52-year old, female nurse who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneously/intradermally. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first dose of two planned doses of MRNA-1273 (Lot Number: 039K20A) subcutaneously/intradermally in the right deltoid zone for prophylaxis of COVID-19 infection. On 20 Jan 2021, the nurse received the mRNA-1273 vaccine subcutaneously/intradermally. No treatment for the event was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, she got the vaccine subcutaneously/intradermally was considered resolved on 20 Jan 2021.; Reporter's Comments: This case concerns a 52 year old female nurse who received her first dose of two planned doses of MRNA-1273 (Lot Number: 039K20A) subcutaneously/intradermally in the right deltoid zone for prophylaxis of COVID-19 infection. There were no reported adverse events associated with the event of incorrect route of product administration.

Other Meds:

Current Illness:

ID: 0993953
Sex: F
Age:
State: AZ

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/02/2021
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: Patient was receiving the 1st dose and the needle broke away from the syringe; Vaccine leaked on the floor, not sure if patient received any vaccine; A report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the needle breaking away from the syringe and vaccine leaking on the floor. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. The reporter that they vaccinated a patient with the first dose and the needle broke away from the syringe, the vaccine leaked on the floor, and they were not sure if the patient received any vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was considered resolved.; Reporter's Comments: This case a concerns a patient who received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and experienced the needle broke away from the syringe, the vaccine leaked on the floor, and they were not sure if the patient received any vaccine. There we no reported adverse events after vaccine was administered.

Other Meds:

Current Illness:

ID: 0993954
Sex: U
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: Vial was punctured for over two weeks; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) after the vial was punctured for over two weeks. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received the second of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On the unknown date, the vaccine administration facility had administered the second dose of the Moderna COVID-19 vaccine to the patient. After they administered the dose, the facility realized that the same COVID-19 vaccine vial had not been properly stored or disposed of after it was previously punctured. The vial had been expired for about 2 weeks. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable. The event, vial was punctured for over two weeks, was considered resolved.; Reporter's Comments: This case concerns a patient who received the second of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection and vial was punctured for over two weeks. There were no reported adverse events after the vaccine was administered associated with the event of out of specification product use.

Other Meds:

Current Illness:

ID: 0993955
Sex: M
Age:
State: FL

Vax Date: 01/17/2021
Onset Date: 01/18/2021
Rec V Date: 02/02/2021
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: nose bleed; This is a spontaneous report from a contactable consumer (patient's daughter). An elderly 79 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 17Jan2021 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications includes Aspirin. The reporter informed that her father (patient) received the first dose of the COVID-19 vaccine yesterday (17Jan2021) and today (18Jan2021), he experienced nose bleed. The patient had a nose bleed which lasted for a pretty long time. The patient just tried to stop it in a regular way. Just pinching the nose and stuff like that. The reporter did not know if there is any other medication that he takes only the Aspirin. The reporter just wanted to know if this was normal side effect. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up (18Jan2021): New information received from a contactable consumer (patient's daughter) included: concomitant drug, event details. Information on the lot/batch number has been requested.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 0993956
Sex: F
Age:
State: FL

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 02/02/2021
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: felt extremely thirsty; facial flushing; Mild hives on face neck and upper chest; Mild cognitive and speech slowing; Mild cognitive and speech slowing; Felt strange sensation on top of head; This is a spontaneous report from a contactable Other Health Professional (patient). A 58-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 14Jan2021 04:00 PM (vaccine location: right arm) at single dose for COVID-19 immunisation.The patient's medical history included hashimotos, fibromyalgia, known allergies to sulfa drugs and extreme shellfish. There is no other vaccine in four weeks. The concomitant drug included levothyroxine sodium (SYNTHROID), Amitriptyline, Valsartan, Vitamin D. After about 12 mins from shot on 14Jan2021 04:15 PM, patient felt extremely thirsty. Then spouse noted facial flushing and called an advanced registered nurse practitioner (ARNP) on site to eval. Mild hives on face neck and upper chest developed then. Then increase flushing on face. Mild cognitive and speech slowing. Felt strange sensation on top of head. Self medicated with 50 mg Benadryl capsule. Emergency medical technician (EMT) and ARNP insisted should go to emergency room (ER), in ambulance not with spouse. Other treatment included OTC ongoing Benadryl and Pepcid. The outcome of events was recovered in Jan2021. Information on the batch number has been requested.

Other Meds: AMITRIPTYLINE; SYNTHROID; VALSARTAN; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 0993957
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/02/2021
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: A patient has received the first dose of the vaccine and his second dose is due tomorrow. 4 days ago the patient tested positive and is nonsymptomatic; A patient has received the first dose of the vaccine and his second dose is due tomorrow. 4 days ago the patient tested positive and is nonsymptomatic; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received the first dose of the vaccine and his second dose was due tomorrow (19Jan2021). 4 days ago (14Jan2021), the patient tested positive for Covid test and was not symptomatic. The doctor asked to call the company to see if it was alright to give the second dose. The outcome of the event was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.

Other Meds:

Current Illness:

ID: 0993958
Sex: F
Age:
State:

Vax Date: 12/29/2020
Onset Date: 01/08/2021
Rec V Date: 02/02/2021
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: tested positive for the virus; tested positive for the virus; This is a spontaneous report from a non-contactable Nurse (patient). A female patient of an unspecified age (58 unit unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer vaccine, and on the 8th (Jan2021) tested positive for the virus. The facility she was tested at stated that the patient cannot get the shot for 14 days for the quarantine time. The patient wanted to know if she has to wait 10 or 14 days to get the vaccine and tomorrow was day 12. The patient informed that she was due to get her 2nd dose tomorrow (19Jan2021). The outcome of the events tested positive for the virus was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.

Other Meds:

Current Illness:

ID: 0993959
Sex: M
Age:
State: MI

Vax Date: 01/15/2021
Onset Date: 01/17/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason. Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.

Other Meds:

Current Illness:

ID: 0993960
Sex: F
Age:
State: NC

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she got it Thursday and that night she noticed a little itching/itching a little again in the palm of her hands; some face soreness; her BP was 152/85 that was high; she has to got the rash on her behind where she has been scratching; having an allergic reaction; a little puffiness on her lip; the cellulitis part of her skin; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247), via an unspecified route of administration on 14-JAN-2021 at the 72 years old at single dose for COVID-19 immunization. The medical history included COPD so sometimes she would cough, kidney stent, rheumatoid ("two" Tylenol and 20 mg prednisone for "her rheumatoid"). The concomitant medication was clarithromycin (MACROBID) from an unspecified date to 12Jan2021. The patient got it on the 14Jan2021. She says she had been doing fine she didn't know now. She was a retired paramedic so she usually felt things out, she got it Thursday and that night she noticed a little itching on 14Jan2021 but she did not think anything of it. Friday evening she had a good time eating some walnuts and she woke up about 2:30 itching that was Saturday morning before day, she took Benadryl and went back to sleep later then later on she was itching a little again in the palm of her hands and she just took a Benadryl and it went away. Then Sunday night, last night, she was okay so she decided to go to the pharmacy to get some Benadryl, they had no Benadryl and she only had old Benadry. Then about 12:30 she started itching on her bottom, itching on her arms and she was scratching. She noticed she was having some face soreness in Jan2021 but she was using some expired facial cream so she thought that was why her face was sore so she put some hydrocortisone cream on it. Since she was itching she decided to take a little of her nieces Benadryl, it is pediatric Benadryl. She was itching so she called her doctor and she heard him in the ER say they had too many people in there to tell her to go to the ER so she said okay. She hung up and called the pharmacy and they said it sounds like having an allergic reaction in Jan2021 and she told him she had the COVID vaccine but she doesn't think she was short of breath and she gave them her vitals her BP was 152/85(BP 157/85) that was high for her in Jan2021, but it came down, she took some Tylenol then it was 146/77, her pulse rate was 77 and her respirations were good she did not have shortness of breath or cough well she has COPD so sometimes she would cough. Then she got up and said let me go one over and get some Benadryl so she went by there got some good Benadryl and she thought she would call and see what they think about all this. She took the Benadryl at 10:25 and she is doing okay right now but she had whelps, she has to got the rash on her behind where she has been scratching in Jan2021, it is on the left side of her hip, the cellulitis part of her skin that is mostly where she is itching in Jan2021. She remembers when she worked at the health department they would give Benadryl and Prednisone. She thought if the Benadryl does not help then she would call, then she decided she would go ahead and call to see what information they have. She says Pfizer is giving her alerts that she has been answering but she did not have the itching at that time. She retired from being a paramedic in 2009. She says she is 72 now but she woke up in 1985 and her lip was swollen like not totally swollen but her top lip was swollen more than the bottom in Jan2021. They gave her an Epinephrine shot and Benadryl and she is just wondering if this itching is related to the vaccine or if it is just an allergy that she may have come up on or something like to the walnuts or something. She says they went there and they gave the shot and they gave Benadryl but they are not sure. She said the doctor never figured our what it was that cause it and it never happened again until she did notice a little puffiness on her lip again this morning. She said the itching first started around 2:34 AM in the morning before light. It had improved since taking up to date Benadryl. She was supposed to get her second dose 04Feb2021. She didn't want COVID 19. She knew she just came off, she had a kidney stent and she had stopped taking 2 days before, she was taking Macrobid. She was not taking that right now. She took a lot of other medications but the Macrobid she was just on and it was stopped on Tuesday 12Jan2021, 2 days before the vaccine. She didn't know if the Macrobid would interfere with getting vaccine. The outcome of the event itching was recovering, the other events was unknown.

Other Meds: MACROBID [CLARITHROMYCIN]

Current Illness:

ID: 0993961
Sex: F
Age:
State: TX

Vax Date: 01/12/2021
Onset Date: 01/01/2021
Rec V Date: 02/02/2021
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: cannot hold anything down her stomach/ what she did eat came back up; bad headaches; bad aches; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient started to receive the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EH9899), via an unspecified route of administration at right arm muscle on 12Jan2021 in the morning about 9:30AM or 10:00AM at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had not had a vaccine before vaccination. The patient was experiencing bad aches in Jan2021, bad headaches started 15Jan2021 about 17:30, Friday evening when she got off work and cannot hold anything down her stomach when she got up about 8:00 on 16Jan2021. What could she take to settle her stomach. She didn't each much at all, but what she did eat came back up. She was scared to eat something at the moment. She was just lost. She went to the Emergency Room on 16Jan2021, but it was a long wait so she went home. The outcome of events bad headaches and cannot hold anything down stomach was not recovered, of the other event was unknown. She wanted to know what she should take for these side effects and if the 2nd dose was optional. She wanted to know if she would feel better after the 2nd dose of the vaccine. She also wants to know if it was possible for her kids to get the virus if she was having the side effects, how long does the Pfizer-BioNTech Covid-19 Vaccine remain in the system. It was not reported as serious.

Other Meds:

Current Illness:

ID: 0993962
Sex: M
Age:
State: PA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 02/02/2021
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: Lymphangitis of left underarm, swollen out to size of softball; administration date=16Jan2021/ 31Dec2020; This is a spontaneous report from a contactable other HCP(patient). A 37-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration at left arm on 16Jan2021 16:45 at single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease(GERD), insomnia. There was no Known allergies. Concomitant medication included zolpidem tartrate (AMBIEN), pantoprazole sodium sesquihydrate (PROTONIX). There was no other vaccine in four weeks. Patient previously first dose BNT162B2(lot number=EK5730) on 31Dec2020, 19:00 at Left arm at single dose for COVID-19 immunization. The patient experienced Lymphangitis of left underarm, swollen out to size of softball on 18Jan2021 10:00, occupational health advised to get seen,went to Emergency room, urgent care recommended paracetamol (TYLENOL)for swelling and no anti-inflammatories that may hinder the immune process. Treatment paracetamol was received. Outcome of the event was recovering. There was no covid tested post vaccination.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "Lymphangitis of left underarm, swollen out to size of softball" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.

Other Meds: AMBIEN; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]

Current Illness:

ID: 0993963
Sex: M
Age: 69
State: WV

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 02/02/2021
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: Received a Moderna vaccine at another clinic 12/30/20. 1/27/2021 he received a Pfizer vaccine at clinic

Other Meds:

Current Illness:

ID: 0993964
Sex: M
Age: 64
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/02/2021
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: None

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Fever to 101.7 body weakness sweats dysentery feeling of malaise, duration ran 48 hours

Other Meds: Metform

Current Illness: Non

ID: 0993966
Sex: F
Age: 44
State:

Vax Date: 01/25/2021
Onset Date: 02/02/2021
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Intermittent tingling/numbness to left arm after vaccine x 8 days after. Intermittent tingling/numbness to left leg after vaccine x 8 days after. Noticed small erythematic area 3 cm x 3 cm around injection site. ED MD noted, no cellulitis.

Other Meds:

Current Illness:

ID: 0993967
Sex: M
Age: 65
State: FL

Vax Date: 01/14/2021
Onset Date: 01/22/2021
Rec V Date: 02/02/2021
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: N/A

Symptom List: Injection site swelling, Limb discomfort

Symptoms: For informational purposes, I am a health care provider myself. I have been experiencing severe episodes of vertigo, starting approximately 1 week after receiving my first dose of the Pfizer vaccine, and only when lying in bed. They occur a few times per night, and have occurred essentially every night since they started. They are very intense, but also very short in duration, of about 3-5 seconds. When I called my primary care physician to see if she had any thoughts, or suggestions, or if she thought it could be due to the vaccine, she informed me that she also had the same reaction, severe vertigo, while lying in bed, at about the same time period, 1 week after her first injection, although she just had 2 isolated episodes of it, and she had the Moderna vaccine. Neither of us have seen any published information listing this as a side effect of the vaccine.

Other Meds: Losartan 100mg daily Zyrtec 10mg daily Methyl B!@ 1000mcg 2x/week Vitamin D3 5000iu 4x/week

Current Illness: N/A

ID: 0993968
Sex: F
Age: 49
State: PA

Vax Date: 12/29/2020
Onset Date: 12/31/2020
Rec V Date: 02/02/2021
Hospital:

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

Lab Data:

Allergies: diflucan, morphine, msg

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

Symptoms: bilateral hip joint pain

Other Meds: multivitamin, pramapaxole, sertraline, levothyroxine, proprano

Current Illness: sinus infection

ID: 0993969
Sex: F
Age: 27
State: CA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/02/2021
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: None

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

Symptoms: ?Moderna COVID-19 Vaccine EAU? Fever and chills for 1 day and sore arms for 3-4 days Took tylenol for the fever and cold compress for the sore arms.

Other Meds: Tylenol

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm