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**
PLEASE CHECK BACK SOON
Download the files above while you wait.






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: 1353162
Sex: F
Age:
State: GA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 05/27/2021
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: 101 temp for two days.; Chills; sweats; muscle aches and joint all over; muscle aches and joint; headache; severe fatigue; diarrhea; Dizziness; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: unknown), via an unspecified route of administration, administered in left right on 29Jan2021 02:15 pm at the age of 70 years old as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. On 30Jan2021, at 03:00am, the patient experienced 101 temp for two days, Chills, sweats, muscle aches and joint all over, headache, severe fatigue, diarrhea, Dizziness and it my weakness. Reporter considered the events as non-serious. No treatment was received for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 30Jan2021 and result was 101 temp for two days. The outcome of the events was recovered on 30Jan2021. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353163
Sex: F
Age:
State: GA

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 05/27/2021
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: Severe headache; Fever; Muscle and joint pain; Muscle and joint pain; Lethargy; This is a spontaneous report from a contactable consumer (patient) reported. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via unspecified route of administration, administrated in left arm on 03Feb2021 at 15:00 as 2nd dose single for COVID-19 immunization. The patient medical history included fibromyalgia, arthritis. Allergies to medications, food, or other products: amoxicillin. Patient received first dose (BNT162B2, Batch/Lot no: EL0140) via an unspecified route of administration, administrated in right arm on 01Jan2021 at 10:00 for COVID-19 immunization. the patient concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in hospital. On 04Feb2021 at 03:00am, patient experienced severe headache, muscle and joint pain, fever, lethargy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353164
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: However, on the second day, she had a headache and still has a headache today that continues to get wors; She still has this banging in her head; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient reported that first day after the second dose, she had no reaction, however, on the second day, she had a headache and still has a headache that continues to get worse. Patient received treatment medication ibuprofen once in a day for event headache and it was getting worse and it was not unbearable, but she still has this banging in her head. In a caller response the patient states that after the first shot, her headache went away after 2 days, however, after the second dose, she's still having the headache after the 6th day. Patient is asking what she should do. Outcome of the event headache was not recovered, head banging was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130300 similar report from same reporter

Other Meds:

Current Illness:

ID: 1353165
Sex: M
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 01/01/2021
Rec V Date: 05/27/2021
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: Headache; head felt like it was going to explode/head seemed full; blood pressure was higher; feel like I am racing and I can't relax, like I drank a bunch of caffeine drinks; a red area the size of the band aid/impression of the bandaid was all reddish; still black and blue from vaccine shot/arm was still bruised; This is a spontaneous report from a contactable Consumer or other non health professional (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EL3247 and expiration date were not reported), via an unspecified route of administration, administered in arm left on 28Jan2021 at 09:25 as 1st dose, single for COVID-19 immunisation. The patient medical history included prostate cancer from 02Dec2020 to an unknown date, diabetes from an unknown date and unknown if ongoing , blood pressure from an unknown date and unknown if ongoing (blood pressure was higher), blood thinner (anticoagulant therapy) from an unknown date and unknown if ongoing , neuropathy from an unknown date and unknown if ongoing, cholesterol from an unknown date and unknown if ongoing, allergy: trees grass and pollen mold, from an unknown date and unknown if ongoing. Family history included stroke from an unknown date and unknown if ongoing (dad had a stroke 20 years ago). Concomitant medications included insulin aspart (FIASP) at an unknown dose, daily (sliding scale dose; take with meals by injection daily) for diabetes (taking 8 years) from an unspecified start date and ongoing; insulin glargine (LANTUS, injection) at 14 mL once daily by injection for diabetes (taking 8 years) from an unspecified start date and ongoing; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) at 100mg/12.5mg once daily by mouth (orally) for blood pressure (taking for 8 years; added the HCTZ 3 years ago; no product to provide information for the old product, added the HCTZ to his Losartan product about three years ago. He has none of his old Losartan product to provide NDC, lot or expiration date) from an unspecified start date and ongoing; pentoxifylline at 400mg three times daily by mouth (orally) as blood thinner (taking 4 or 5 years) from an unspecified start date and ongoing; gabapentin at 400mg three times daily by mouth for neuropathy (taking for 5 years) from an unspecified start date and ongoing; atorvastatin at 10mg once daily by mouth for cholesterol (taking for 5 years) from an unspecified start date and ongoing; Align Daily Probiotic Supplement at an unknown dose once daily by mouth for an unspecified indication from an unspecified start date and ongoing; calcium at 500mg twice daily by mouth for an unspecified indication from an unspecified start date and ongoing; aspirin (acetylsalicylic acid) at 81mg once daily by mouth for an unspecified indication from an unspecified start date and ongoing; fish oil at an unknown dose for an unspecified indication from an unspecified start date and ongoing; vitamin D3 at an unknown dose for an unspecified indication from an unspecified start date and ongoing, multivitamins at an unknown dose once daily by mouth for an unspecified indication from an unspecified start date and ongoing, and products allergy shots at an unknown dose by injection monthly for allergy: trees grass, pollen mold from 1994 and ongoing. On an unspecified date in Jan2021, the patient experienced headache, head felt like it was going to explode, blood pressure was higher, feel like I am racing and I can not relax, like I drank a bunch of caffeine drinks, a red area the size of the band aid/impression of the bandaid was all reddish, and still black and blue from vaccine shot/arm was still bruised. The clinical course of the event was reported as follow: the patient received 1st dose of the COVID vaccine last Thursday, 8 days ago (as reported), he got headaches, and he inquired how long do they last. Headache started a couple days after, his head felt like it was going to explode, his blood pressure was higher, base line was 120/70 - 130/75, it went to 150/. The doctor turned off the light and it went to 130/. He had not had it that high in a long time, his dad had a stroke 20 years ago and inquired if all of this related to the vaccine. He felt like he was racing and he could not relax, like he drank a bunch of caffeine drinks. This started just after getting the vaccine, could be a coincidence, but could be something else. He got an allergy shot today at 10:00 am eastern time, in the arm where they did the vaccine. It was still black and blue from vaccine shot, the band aid the person put over it, he asked if he was allergic to latex. He reported that where the band aid was, it was a red area the size of the band aid. He questioned that there was latex in his vaccine or was this due to the band aid, making a red mark after he had taken off the band aid for 7 days. Going to healthcare professional on Monday (as reported), he talked with his medical assistant and set up an appointment. He also inquired if increased blood pressure was side effect and how long did it last. The patient mentioned he asked his son who was a pharmacist and he did not know the answer to his question about his headache. Patient stated his head seemed full and now after a week he still had a headache. He added it felt like his head was going to explode. It was still there but better now but it came and went. His blood pressure was up too. Usually, it was only 130 at the top but now it was 130 to 150 on the top. Added he felt like he was racing all the time and could not relax. He was unsure how long after the vaccine he noticed these effects but stated it had been going on for several days. He was scheduled to get the second dose 18Feb2021. Patient went to get his allergy shot today (as reported) and when the nurse went to do the shot, his arm was still bruised and where they put the bandaid over there was an impression of the bandaid was all reddish. No events required a visit to physician or ER (emergency room). No prior vaccinations (within 4 weeks) were reported. 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 outcome of the event headache was recovering, outcome of the event head felt like it was going to explode was unknown, and outcome of the other events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: FIASP; LANTUS; LOSARTAN HCTZ; PENTOXIFYLLINE; GABAPENTIN; ATORVASTATIN; PROBIOTICS; CALCIUM; ASPIRIN [ACETYLSALICYLIC ACID]; FISH OIL; VITAMIN D3

Current Illness:

ID: 1353166
Sex: F
Age:
State: PA

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 05/27/2021
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: Intractable headache; Lowgrade fever; Chills; Fatigue; Malaise; This is a spontaneous report from a contactable Other HCP (patient). A 34-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route on 04Feb2021 at 12:30 (at the age of 34-years) as 2nd dose, single in left arm for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccine in four weeks of vaccination. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN). The patient previously received first dose of BNT162B2 (Lot number: EL0142), via an unspecified route on 14Jan2021 at 12:30 (at the age of 34-years) as 1st dose, single in left arm for COVID-19 immunisation. Patient was not diagnosed with COVID prior vaccination. The patient was not pregnant at the time of vaccination. On 05Feb2021 at 12:00, the patient experienced intractable headache, chills, low grade fever, fatigue and malaise. Post vaccination the patient was not tested for COVID. Treatment was not received for the reported events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: WELLBUTRIN

Current Illness:

ID: 1353167
Sex: F
Age:
State: MN

Vax Date: 01/28/2021
Onset Date: 02/02/2021
Rec V Date: 05/27/2021
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: severed headache; chills; fever of 102; This is a spontaneous report received from a contactable Nurse (patient herself). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 28Jan2021 08:15 (at the age of 56-year-old) as 1st dose, single for COVID-19 immunization. Medical history included drug hypersensitivity (penicillin) from an unknown date and unknown if ongoing, patient had no other medical history. Concomitant medication(s) included calcium, vitamin d nos and paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 02Feb2021 15:00 the patient experienced severe headache, chills and fever of 102. Patient was not diagnosed with COVID-19 Prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 102 on 02Feb2021 Fever, polymerase chain reaction: negative on 04Feb2021, sars-cov-2 test: negative on 04Feb2021. The reporter assessed all the events as non-serious. The outcome of the events was reported as recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: CALCIUM; VITAMIN D NOS; TYLENOL

Current Illness:

ID: 1353168
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: high fever now 102.4?F; This is a spontaneous report received from a contactable consumer (patient's wife) via a Pfizer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unknown date as 2nd dose, single for covid-19 immunization. On an unknown date (this happened after the second dose of vaccine), the patient was experienced high fever now 102.4 degree F and already taken paracetamol (TYLENOL) for fever. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353169
Sex: F
Age:
State: AZ

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 05/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Severe headache; increased heart rate avg. 103 bpm; very dry throat; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration in Right Arm on 06Feb2021 at 03:45 PM as 2nd dose single and first dose via an unspecified route of administration on 16Jan2021 at 11:00 PM as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any vaccine in 4 weeks and 2 weeks prior vaccination. The patient did not tested covid prior and post vaccination. Patient was having no allergies. On 07Feb2021 at 09:00PM, the patient experienced severe headache, increased heart rate avg. 103 bpm and very dry throat. The patient did not receive any treatment. The patient underwent lab tests and procedures which included heart rate: increased heart rate avg. 103 bpm on 07Feb2021. The clinical outcome of the events was not recovered. Information about Lot/batch number has been requested. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353170
Sex: F
Age:
State: VA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 05/27/2021
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: Fever 101.5; headache; back pain; hip pain; dizziness; nausea; arm pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 61-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL 9269 and Expiry date: unknown), dose 2 via an unspecified route of administration, in the left arm, on 06Feb2021 at 11:30 (age at vaccination 61-year-old), as single for COVID-19 immunization in the hospital. The patient's medical history included psoriasis, fibromyalgia and vitamin b12 deficiency. The patient had drug allergy which were contrast media allergy, vancomycin allergy. The patient concomitant medications included amitriptyline, vitamin B12 NOS, vitamin D NOS taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982 and Expiry date: unknown), dose 1 via an unspecified route of administration, in the left arm, on 17Jan2021 at 11:30, as single for COVID-19 immunization. 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 was not tested for COVID-19 since the vaccination. On 06Feb2021, the patient experienced fever 101.5, headache, back pain, hip pain, dizziness, nausea, arm pain. The patient underwent lab tests and procedures which included body temperature 101.5 on 06Feb2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: AMITRIPTYLINE; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1353171
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 05/27/2021
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: She is just not feeling well; flare up of her environmental allergies (sneezing, itchy, watery eyes.); Sneezing; coughing; congestion; itchy; watery eyes; headache; fatigue/She sleeps 10 hours every night and she does not feel rested; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN5318) via an unspecified route of administration in left arm on 02Feb2021 (at the age of 45-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history included seasonal allergy, allergic conjunctivitis, environmental allergies. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced very intense flare with sneezing, coughing, congestion, itchy, watery eyes. Patient reported that she remembers she took it that evening. she got it through her job and she was able to go after work and immediately she felt fatigue on 02Feb2021. She was sleeping that whole night and that has continued she has had the same level of fatigue since then. She sleeps 10 hours every night and she does not feel rested. She had headache that started the next morning wednesday on 03Feb2021. It's like headache, head pressure and she know that's expected and she would say it's been the same level of intensity until about saturday or sunday slowly getting less but it's still there. She had a question of duration and is this normal symptoms and how long they last and the agent said she doesn't have the information for the first dose. She has seasonal allergies, environmental allergies and she had a break for a couple weeks and did not have any kind of flare, they were under control with medications then thursday. She started having a very intense flare sneezing, coughing, congestion, itchy, watery eyes, things she would normally take meds for, the meds are not working. She takes over the counter or prescribed meds she has still been taking them but she is flared up more than usual these past few days. She names of medications, she can check know the Allegra. It was reported that patient spoken 2 different people but she was calling reporting some of side effects that were listed but then she have had some questions about duration of some of them after the first dose. She have had other symptoms that were not listed on the list and she was wondering if there were connections to the vaccine. She was just not feeling well, she did called her doctor but saw the number on the fact sheet and she wanted to called pfizer as well. Patient took medications such as flonase for her nose and the lot number is AB1350A expiration May2022, Allerfex for her eyes lot number is 0FR0350 and expiration Jan2022. The new eye drop she has been on for 2 weeks is Ellistat, the eye drop lot number F0904 and expiration Sep2021. The outcome of the events headache was recovering, fatigue was not recovered and other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353172
Sex: F
Age:
State:

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 05/27/2021
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: Headache; muscle aches; joint pain; fever over 101; chills; fatigue; swelling of injection site; injection site pain; slight nausea; stomach cramping; This is a spontaneous report from a non-contactable other HCP. A 39-year-old non pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, (Lot Number: EL1484 expiry date unknown), via unspecified route of administration in left arm on 05Feb2021, 03:15 PM (at the age of 39-year-old) as a single dose for covid-19 immunization. The patient medical history included sulfa antibiotics allergy. The patient's concomitant medications were not reported. The patient did not have any other vaccination prior to 4 weeks of COVID vaccine. Patient did not diagnose with COVID prior to vaccine and not tested for COVID-19 after vaccination. On 05-Feb-2021: 18:30 the patient experienced headache, muscle aches, joint pain, fever over 101, chills, fatigue, swelling of injection site, injection site pain, slight nausea, stomach cramping. No treatment received for adverse events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1353173
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: After the first shot, her headache went away after 2 days; After the first shot, her headache went away after 2 days; dull pain; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as first dose, single for covid-19 immunization. The patient past medical history and concomitant medication was not reported. the patient reported that she received the second dose of the COVID vaccine 6 days ago. The first day after the second dose, she had no reaction, however, on the second day, she had a headache and still has a headache today that continues to get worse on an Unspecified date. She was not taking Ibuprofen every 4 hours and only took 2 tablets about 3 or 4 hours ago. She had dull pain that doesn't go away. The outcome of event was not recovered. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected. .; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122285 similar report from same reporter

Other Meds:

Current Illness:

ID: 1353174
Sex: F
Age:
State: NE

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 05/27/2021
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: Mild headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 05Feb2021 as a 1st dose, single for COVID-19 immunisation. Co-suspect medication included Aimovig (ERENUMAB AOOE) for migraine. The patient's medical history included migraines for 67 years. The patient's concomitant medications were not reported. Stated that she took the first dose of covid vaccine on the 05Feb2021 and she did not have any side effects aside a mild headache (patient said that she always gets a headache since she had migraine for 67 years). Patient stated that she takes an injection of Aimovig (for Migraine) every 10th of every month and she would like to know whether if it interferes with the covid vaccine and she should skip/take it later. The patient stated that she usually take 2 Tylenol for a headache and she was good to go. On an unspecified date in Feb2021, the patient experienced headache. Treatment medication included Tylenol. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353175
Sex: F
Age:
State: MA

Vax Date: 02/03/2021
Onset Date: 02/05/2021
Rec V Date: 05/27/2021
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: Headache; discomfort; nausea; diarrhea; This is a spontaneous report from a non-contactable consumer (patient herself). A 30-year-old non-pregnant female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 03Feb2021 16:00 (at the age of 30-years-old) as single dose for COVID-19 immunisation. The patient medical history included Known allergies: Bacitracin. Concomitant medication included vitamins nos taken for an unspecified indication, received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has been tested for COVID-19 post vaccination. On 05Feb2021, the patient experienced, Headache, discomfort, nausea, diarrhea and received no treatment for adverse events. The patient underwent lab tests and procedures which included Nasal Swab: PCR (sars-cov-2 test): negative on 04Feb2021. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/Batch number could not be obtained.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1353176
Sex: F
Age:
State: CO

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 05/27/2021
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: Severe body aches; Headache; Nausea; Diarrhea; Tiredness; Feeling of unwell; Lung and chest pain; Lung and chest pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Feb2021 18:30 (at the age of 65-year-old) as single dose for covid-19 immunisation. Medical history included arthritis, inflammation, covid prior vaccination on 10Mar2020. The patient was no known allergies. There were no concomitant medications. On 04Feb2021 at 09:00, patient experienced severe body aches, headache, nausea, diarrhea, tiredness, feeling of unwell, lung and chest pain. There was no treatment. The patient was not pregnant. There was no covid tested post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1353177
Sex: F
Age:
State: WA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 05/27/2021
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: headache; fever; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EK9231, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 10:30am (at the age of 37-year-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccination included first dose of BNT162B2, lot number: EH9899) via an unspecified route of administration, administered in left arm on 12Jan2021 10:30am for COVID-19 Immunization. Patient did not take other vaccine in four weeks. On 02Feb2021 the patient experienced, about 14 hours after 2nd dose, developed a fever of 101.5 and a headache. This lasted about 24 hours but improved, especially with over the counter dose of acetaminophen. Lower fever (100.5) persisted for another 24 hours. All symptoms resolved within 48 hours. Patient did not receive any treatment for AE. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The patient underwent lab tests and procedures which included body temperature: lower fever (100.5) on an unspecified date (Lower fever persisted for another 24 hours), body temperature is 101.5 on 02Feb2021. The outcome of the events was reported as recovered on 04Feb2021. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353178
Sex: F
Age:
State: AZ

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 05/27/2021
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: headache; Soreness in left arm; nausea; swollen face on left side; dizziness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Known allergies to Penicillin. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 in the right arm on 15Jan2021 (Lot number: unknown) for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. On 05Feb2021, the patient experienced soreness in left arm, nausea, dizziness, swollen face on left side and headache. No treatment received for AE. On 07Feb2021, the patient tested COVID post vaccination. The patient tested Nasal Swab and the result was negative. Outcome of the events was recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353179
Sex: M
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 05/27/2021
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: Frequent headaches since receiving the vaccine 11 days ago with tingling in fingers on left hand; Frequent headaches since receiving the vaccine 11 days ago with tingling in fingers on left hand; This is a spontaneous report from a contactable 68-year-old male consumer reported for himself that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:30 (Batch/Lot number was not reported) as, SINGLE for covid-19 immunization. The patient's medical history included allergic to penicillin, erythromycin and lactose intolerant from an unknown date and unknown if ongoing. Concomitant medications included simvastatin, lisinopril and primidone; all used for unknown indication start and stop date was not provided. On 29Jan2021 at 07:00 AM, the patient experienced frequent headaches with tingling in fingers on left hand. Patient was not received any treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The outcome of both events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: SIMVASTATIN; LISINOPRIL; PRIMIDONE

Current Illness:

ID: 1353180
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 05/27/2021
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: headache for 18 days; vision problems where her eyes were glassy; her muscles of her legs the first day bothered her; chills on and off; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Jan2021 as single dose for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on an unknown date in 2021 on Thursday at 02:00 PM as single dose for COVID-19 immunization. Patient's medical history was reported as none. The patient concomitant medication included unspecified flu vaccine (NDC/LOT/EXP unknown) on an unknown date at the end of Oct2020. She stated that she was lucky to be so healthy, she was active. An unknown date, after receiving the first dose of vaccine, the patient experienced headache for 18 days; described as the headache was not a pounding headache, it was a sickly headache at the back of her neck, like we would get when had a temperature. She did not had temperature. She also experienced vision problems where her eyes were glassy and bothered her and could not do her reading. The patient also experienced chills which were on and off and her muscles of legs the first day bothered her. The reporter stated that her doctor told her that the cases and deaths of COVID-19 are high and it would be better for her to receive the second dose despite her reactions. The reporter wanted to know if the Pfizer COVID vaccine dosage is weight based. The reporter stated that her friend mentioned that a 400 pound man may be given the same dose, so she wanted to know if the vaccine can be given based on weight. The reporter stated that she was not sure of lot number as it was hand written and says Pfizer COVID-19 LOT EL or EC, 3247. The reporter stated that her brother and two of her friends had the Pfizer vaccine and they do not have any side effects. Therapeutic measures were taken as a result of headache and the patient received treatment with ibuprofen IB tablets (UPC: 09661988088-1, EXP: Oct2021). The reporter stated that she was ecstatic or thrilled that she does not have headache at the time of report. She also stated that since even her muscles of her legs the first day bothered her, though it subsided after that. The outcome of the events vision problems where her eyes were glassy and chills on and off was reported as unknown whereas headache was reported as recovered. The outcome of the event muscles of her legs the first day bothered her was reported as recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353181
Sex: F
Age:
State: NJ

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 05/27/2021
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: headache; hard to sleep; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 78-years-old) as single dose for covid-19 immunisation. On an unspecified date, the patient started receiving lisinopril (LISINOPRIL) Dosage text: 20mg, 1 tablet, oral for blood pressure measurement, cardiac disorder and was Ongoing. No lot number was provided for Lisinopril due to Product dispensed in pharmacy vial. The patient was taken Covid vaccine due to her age and heart issues. Relevant medical history and concurrent conditions included pacemaker inserted on Oct2011 and ongoing, had it replaced Jan2020. No further details provided. Pertinent Details include surgical procedures and dates were Pacemaker inserted Oct2011 and Jan2020. No other AE following prior vaccinations. No family Medical history relevant to AEs. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect was None. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other Prior Vaccinations were taken within 4 weeks prior to the first administration date of the suspect vaccine. No Other Products were reported. No Investigation Assessment. On an unspecified date in Jan2021, the patient experienced headache and felt hard to sleep. It was reported that patient getting a bit of a headache almost every day for almost 2 weeks. Patient reported about 2 weeks ago she got the first dose of the Pfizer Covid vaccine. She wants to know if this was expected and if it will be worse on the second dose. She had a question about the side effects. It's not serious, but she just had like a headache every day and wondered how long side effects supposing to last. Patient got the vaccine on Tuesday, 26Jan2021 and the headaches started like the next day. It was still there sometimes worse than others and at night it had bothered her more. She doesn't have them nightly and it's hard to sleep. No further details provided. Patient Mentioned she did see the cardiologist and her medication Lisinopril was increased to 20mg once daily. Does not know if that had anything to do with the headaches. Patient clarified the headaches were before she had the medication increase. Not visited Emergency Room due to events. Event headache caused Physician Office to visit. Outcome of the events was not recovered. Follow-up (08Feb2021): This is a follow-up Spontaneous report from a contactable consumer. New information included patient details, RMH, Outcome of the events. Description of Product Complaint: Did see the cardiologist and her medication, Lisinopril was increased to 20mg once daily. Clarifies the headaches were before she had the medication increase. Unable to provide NDC, Lot or expiry from pharmacy bottles. Product strength and count size dispensed: 20mg Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness: Blood pressure; Heart disorder; Pacemaker insertion (cardiac)

ID: 1353182
Sex: F
Age:
State:

Vax Date: 02/03/2021
Onset Date: 02/06/2021
Rec V Date: 05/27/2021
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: Headaches; dizziness; weakness; joint pain; tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262; Expiration Date: unknown) dose 1 via unspecified route of administered in Arm Left on 03Feb2021 11:45 AM as 1st DOSE SINGLE for covid-19 immunisation. The patient medical history was essential thrombocytopenia. Concomitant medications included baby aspirin, lisinopril, pravastatin and tramadol. On 06Feb2021: 07:00 AM the patient experienced headaches dizziness weakness joint pain and tired. Outcome of the events was recovered. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds: BABY ASPIRIN; LISINOPRIL; PRAVASTATIN; TRAMADOL

Current Illness:

ID: 1353183
Sex: F
Age:
State: TX

Vax Date: 02/07/2021
Onset Date: 02/01/2021
Rec V Date: 05/27/2021
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: Today I have a headache/she has a slight headache; This is a spontaneous report from a contactable consumer (patient). A female of unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number: EL9265, Expiry Date: Unknown), via an unspecified route of administration on 07Feb2021 as a, single dose for covid-19 immunization. The patient's medical History included seasonal allergies and sinuses form an unspecified date. Patient's concomitant medications were not reported. In Feb2021 on unspecified date. The patient reported that, she got the vaccine yesterday and she has a slight headache. She wants to know if can take Tylenol. she is not sure if the headache is from the vaccine or her sinuses; she has sinus issues from time to time. Patient also reported that, she has seasonal allergies which may be causing the headache. The outcome of the event was not recovered. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353184
Sex: M
Age:
State: CA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 05/27/2021
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: This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3249), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included hypothyroidism, hyperlipidemia and iodine allergy. The patient received other medications in two weeks. The patient did not had COVID-19 prior to vaccination and did not tested for COVID post vaccination. The patient experienced low grade headache and slight soreness at the injection site on 18Jan2021. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353185
Sex: F
Age:
State: AZ

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 05/27/2021
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; Chills; tiredness; Sore; Felt not well; injection site is painful; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported for a 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318) at 59-year-old as single dose for COVID-19 immunisation. Medical history included ongoing diabetes. Concomitant medication included metformin taken for diabetes. The patient got the first dose on 02Feb2201 and on 03Feb2021 been experiencing headache, chills, tiredness and injection site was painful. Consumer stated, "she got the shot on 02Feb2021 and on 03Feb2021 patient just at all days then she having headache and chills. I noticed "possibility" (not clarified) sore but her question was can patient take like Ibuprofen or something to deal with the headache". Consumer stated, "on 02Feb2021 she got (received vaccine) and this morning (03Feb2021) during the class time. She just felt not well. She calling to see if I can take Advil or ibuprofen for the headache down." When probed still having the problems, consumer stated, "(Yes)." Consumer added, "she just need to know she can take ibuprofen for this headache to "cool down" (not clarified). Outcome of the event headache was not recovered and all other events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: METFORMIN

Current Illness: Diabetes

ID: 1353186
Sex: F
Age:
State: CA

Vax Date: 02/07/2021
Onset Date: 02/08/2021
Rec V Date: 05/27/2021
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: Headache; chills; abdominal cramps; This is a spontaneous report from a non-contactable consumer [patient]. A 73-year-old non-pregnant female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EN5318) via an unspecified route of administration in left arm on 07Feb2021 at 12:45 (at the age of 73-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history included hip pain (meloxicam). Several past surgeries. No chronic health conditions. Concomitant medication included meloxicam for hip pain and super c vitamin (ascorbic acid). No allergies reported. No vaccinations in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient not tested with COVID-19 post vaccination. On 08Feb2021 at 13:15, the patient experienced headache, chills, abdominal cramps. No treatment was received for the adverse events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds: MELOXICAM; C VITAMIN

Current Illness:

ID: 1353187
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: patient that had a headache took a muscle relaxant, should have taken the second shot today.; This is a spontaneous report from a Pfizer-Sponsored Program by a contactable consumer. A Male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number was unknown), via an unspecified route of administration on an unknown date as single for COVID-19 immunisation. The patient's medical history, concomitant medications were not reported. The reporter stated that the patient that had a headache took a muscle relaxant, should have taken the second shot today. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected; Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1353188
Sex: F
Age:
State: FL

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 05/27/2021
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: fever; runny nose; headache; nausea; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old non-regnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) first dose via an unspecified route of administration on 26Jan2021 12:00 as SINGLE DOSE for Covid-19 immunisation.Medical history included and concomitant medications were not reported. . Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Patient was not administered any other vaccines for 2 weeks and patient had no allergies. On 26Jan2021 the patient experienced fever, runny nose, headache, nausea, body aches. The outcome of the events were recovered. Batch/Lot number was not reported at the time of report completion for an unknown reason. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353189
Sex: F
Age:
State: NY

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 05/27/2021
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: Fever for 15 hours >99.8 to max 102.5; Chills intermittently for 1 day; Headache throbbing 1 day; This is a spontaneous report from a contactable other health care professional (patient herself). A 25-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number was not reported), via unspecified route of administration, on 08Jan2021, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL3246), via unspecified route of administration, on 28Jan2021 (in left arm); both doses given at single dose, for Covid-19 immunization. The patient did not have covid prior to vaccination and had no allergies. The patient's medical history included oral contraceptive. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) at dose of 5 mg and piroxicam (PAXIL [PIROXICAM]) taken as oral contraceptive at dose of 30 mg OCP (oral contraceptive). On 29Jan2021 03:00 AM, the patient experienced fever for 15 hours >99.8 to max 102.5, chills intermittently for 1 day, and headache throbbing for 1 day. The patient did not receive any treatment for the events. The outcome of the event was considered as resolving. Follow-up attempts are completed. No further information is expected.

Other Meds: ADDERALL; PAXIL [PIROXICAM]

Current Illness:

ID: 1353190
Sex: F
Age:
State: NC

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 05/27/2021
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: Fever; Achiness; fatigue; malaise; swollen left armpit lymph node; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 05Feb2021 at 09:15 (at the age of 27-year-old) as 2nd dose, single dose in left arm for COVID-19 immunisation at Workplace clinic. The patient's medical history included PCOS (Polycystic ovarian syndrome). Patient had no allergies. Concomitant medications include Wellbutrin XL, Aldactone, Vit D, Zyrtec, Turmeric. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 15Jan2021 at 09:15 as single dose in left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 Friday night at 21:00, 12 hours after the second dose of vaccine, the patient experienced fever, which peaked at 101.6 around 03:00 AM on Saturday and stayed a little above 100 most of Saturday. On 05Feb2021 at 21:00, 12 hours after the second dose of vaccine, the patient also experienced achiness, fatigue, malaise, swollen left armpit lymph node. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.6 on 06Feb2021, fever peaked at 101.6 around 3 AM , body temperature: little above 100 on 06Feb2021, stayed a little above 100. The clinical outcome of the events was recovered on 07Feb2021. Follow-up attempts are completed. No further information is expected.

Other Meds: WELLBUTRIN XL; ALDACTONE; VITAMIN D NOS; ZYRTEC; TURMERIC

Current Illness:

ID: 1353191
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) reported for a female patient (daughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, caller is supposed to get her 2nd dose tomorrow and her daughter had a fever, so they tested her for COVID, but the test came back negative, and she wants to know if it's okay if she still gets the COVID vaccine. She was talking to someone in Program but was disconnected. Provided Program number and cold transferred due to wait times. Fax to Program for AE, since she didn't clarify if she was having symptoms. Program. CEP 2191. The patient underwent lab tests and procedures which included COVID test came back negative. Outcome of the event was unknown. Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353192
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date: 02/01/2021
Rec V Date: 05/27/2021
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: I have been having high fever; I have really bad headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, on 02Feb2021 at a 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 in the past for Covid 19 immunisattion. In Feb2021, the patient experienced high fever and really bad headache. The patient got Pfizer vaccine (clarified as Covid 19 vaccine) the second dose 2 days ago and since then she has been having high fever. She wanted to know because when she was getting the second dose, she was told it will last 24 hours but it's more than 24 hours and it was the second day was it normal or it will go away. The patient stated it was yesterday morning but today was the second day so today morning it was like it completed the 24 hours and now it is already being nighttime and it past 24 hours. The outcome of the events was unknown. In response to further questions, consumer stated, I was already on hold for like 50 minutes.

Other Meds:

Current Illness:

ID: 1353193
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: Headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer or other non hcp, reported for a female patient (wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. Reporter considered the event as non-serious. The outcome of the event was unknown on an unspecified date. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1353194
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: headache; This is a spontaneous report from a contactable consumer. This female consumer reported in response to Non-HCP letter sent via telephonic follow up activity. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration as single dose on unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353195
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: Fever; chills; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration as unknown single for COVID-19 immunization. Patient experienced fever and chills after receiving mRNA vaccination. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353196
Sex: U
Age:
State: NC

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 05/27/2021
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: Severe headache; Chills; Extreme fatigue; Body aches; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age (age: 59; Unit: Unknown) and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 04Feb2021, the patient experienced severe headache, chills, extreme fatigue, body aches. It was reported that side effects experienced on 5 hours after treatment, Chills developed 10 hours after injection, Extreme fatigue developed 8 hours after injection, resolved after a night of rest, body aches developed 8 hours after injection and Still feeling the symptoms after 22 hours from injection. The outcome of events Severe headache, Chills and Body aches was not recovered, and the outcome of event Extreme fatigue was resolved on an unspecified date in 2021. Information on the lot/batch number has been requested. Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1353197
Sex: F
Age:
State: FL

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 05/27/2021
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: Fever; sweats; tingling in hands and feet for 24 hours; This is a spontaneous report from a contactable Consumer(patient). This 65-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration in Left arm on 25Jan2021 at 12:00 pm as single dose for COVID-19 immunization. Concomitant medication(s) included levothyroxine sodium (Levothyroxin), amlodipine, folic acid, esomeprazole sodium (Nexium). Patient medical history was not reported. On 26Jan2021 at 05:00 am, the patient experienced fever sweats tingling in hands and feet for 24 hours. No treatment was received for the events. The patient was COVID prior vaccination. No COVID test was performed post vaccination. The patient had no allergies. The outcome of the events was reported as recovered on an unknown date in 2021.. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOTHYROXIN; AMLODIPINE; FOLIC ACID; NEXIUM [ESOMEPRAZOLE SODIUM]

Current Illness:

ID: 1353198
Sex: F
Age:
State: TX

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 05/27/2021
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: tested positive for COVID 19 on 30Jan2021; she was not feeling well; This is a spontaneous report from a contactable consumer (patient's daughter-in-law). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) at age of 65 years old as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer COVID 19 vaccine on 25Jan2021; then on 26Jan2021 she was not feeling well; and then tested positive for COVID 19 on 30Jan2021. The patient was scheduled to receive the next dose of the vaccine 13Feb2021. Consumer was asking if her mother-in-law should reschedule the second dose of the vaccine because her quarantine will only be up on 12Feb2021. The outcome of events was unknown. This is also being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1353199
Sex: F
Age:
State:

Vax Date: 01/29/2020
Onset Date: 01/29/2021
Rec V Date: 05/27/2021
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: Our arm was sore; Running a little low temperature.; My daughter started to feel a little yucky that evening about midnight; This is a spontaneous report from a non-contactable consumer (patient's mother) via medical information team. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration on 29Jan2021 at 17:30 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Jan2021, the patient started to feel a little yucky that evening about midnight, reporter thought that her daughter may be running a low-grade fever, but her temperature was 97.1 degrees Fahrenheit. The only other reaction was arm was sore for maybe an hour or 2. On 30Jan2021, the patient was feeling fine today and was feeling okay just running a little low temperature. On 30Jan2021, the patient's body temperature was running 97.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 97.1 degrees Fahrenheit on 29Jan2021 and 97.5 degrees Fahrenheit on 30Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353200
Sex: F
Age:
State: MO

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 05/27/2021
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: Headache immediately; chills; Fever; Joint pains; Muscle aches; Fatigue; Nausea; Red bump at the injection site; At 1:00pm this afternoon I can say I am feeling like all systems are gone; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in right arm on 09Feb2021 at 12:30 (Batch/Lot Number: EM9809) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 (tested positive prior to vaccination). The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID -19 immunization, on unspecified date. The patient previously took Levaquin and experienced allergies. On 09Feb2021 12:30 after vaccination the patient experienced headache immediately, then took a 2-hour nap when patient reached home. In the evening patient experienced with chills, fever, joint pains, muscle aches, fatigue, nausea along with the headache. The next morning, patient was not better so called her provider and was told to take Tylenol 2 doses before patient noticed the change in the flu like symptoms. After the 3rd dose of the Tylenol before patient got relief from the headache. Patient slept the entire day and got up at 5:00 pm and had a chicken soup and went back to bed and slept all night. When patient woke up in the morning, she felt so much better. Patient's arm was still sore, and the pain had gone down into her armpit and had a red bump at the injection site but no fever. At 1:00pm afternoon patient said she was feeling like all systems were gone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient took Tylenol for treatment and the outcome of the events was recovered on 11Feb2021. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1353201
Sex: M
Age:
State: NJ

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 05/27/2021
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: Mild fever 100.2; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:45 as 2nd DOSE, SINGLE for covid-19 immunization at work-place clinic (43 year at the time of vaccination). It was reported that previously on 20Jan2021 the pa-tient had her BNT162B2 (Solution for injection, Lot number unspecified) via an unspeci-fied route at 1st DOSE, SINGLE for covid-19 immunization. The patient was healthy before the vaccination. The patient medical history was not reported. Concomitant medication included centrum vita-mints (biotin, calcium pantothenate, chromic chloride, colecalciferol, cyanocobalamin, dl-alpha to-copheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 05:00AM, the patient had his body temperature checked and results show mild fever 100.2 along with headache. The patient did not receive any treatment for the events. The patient also reported that since the vaccination the patient had not been tested for COVID-19. The outcome of the events was reported as recovered on an unknown date at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds: CENTRUM VITAMINTS

Current Illness:

ID: 1353202
Sex: F
Age:
State: FL

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 05/27/2021
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: experiencing a headache and it has gotten worse; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 08Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took the first dose in the morning but prior to that she was experiencing a headache and it has gotten worse since she hasn't taken her Sumatriptan. The patient asked was it okay to take it. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353203
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: developed a headache; felt feverish/ did not have a fever; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 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 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date patient developed a headache and felt feverish about 36 hours after receiving COVID-19 vaccine. Upon checking her temp, she did not have a fever. She also stated she got headaches frequently so wasn't sure if it was related to the vaccine or not. She took aspirin which resolved her headache. The patient underwent lab tests and procedures which included body temperature: did not have a fever on unspecified date. Therapeutic measures were taken as a result of the event headache with aspirin. The outcome of the events was reported as resolved on an unspecified date. No follow-up attempts are possible. Information on the batch/lot number cannot be requested.

Other Meds:

Current Illness:

ID: 1353204
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date: 02/01/2021
Rec V Date: 05/27/2021
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: Apps 15 hours after- 102 fever, fever of 100; extreme chills; 26 hours after, sever body aches; especially though arms; neck ache; ache kidney area; fatigue, no fever but still tired; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EN5318), dose 2 via an unspecified route of administration in left arm on 10Feb2021 at 07:15 (at the age 46 years) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 10:00, (15 hours after) patient experienced 102 fever and extreme chills. On an unspecified date in Feb2021, (26 hours after), patient experienced severe body aches especially though arms, neck, and kidney area, fatigue and fever of 100. On an unspecified date in Feb2021 (48 hours after), patient experienced slightly achy, no fever but still tired. The treatment was not received for the adverse events. The patient has been tested for COVID-19 (SARS-CoV-2 test): negative on 11Feb2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1353205
Sex: F
Age:
State: IL

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 05/27/2021
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: Patient had a headache and fever the evening after receiving the vaccine. The day after patient continues to feel fatigue; Patient had a headache and fever the evening after receiving the vaccine. The day after patient continues to feel fatigue; Patient had a headache and fever the evening after receiving the vaccine. The day after patient continues to feel fatigue; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 11Feb2021 (at the age of 59-year-old) at a 1st dose, single dose for covid-19 immunisation. Medical history included patient was diagnosed with covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient was allergic to clarithromycin and MSG. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. On 11Feb2021 patient underwent lab tests and procedures which included body temperature: fever. On 11Feb2021 patient had a headache and fever the evening after receiving the vaccine. The day after patient continues to feel fatigue. Patient had not been tested for COVID-19 since the vaccination. No treatment received for reported adverse event. Outcome of the events was resolving. Information on the lot/batch number has been requested. Location of injection information was available for all vaccines received on the same date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353206
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: Headache; This is a spontaneous report received from a Pfizer sponsored Program from a contactable consumer or other non hcp. A female patient of an unspecified age received her 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 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The event was assessed as non-serious. The outcome of the event was reported as unknown. Follow-up attempts completed. No further information expected

Other Meds:

Current Illness:

ID: 1353207
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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: Low grade fever; Bodyaches; Headache; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN, Expiration date:UNKNOWN), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN, Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. On an unspecified date after second dose, the patient experienced low grade fever, it is got an 100.7, body aches, headache. It was reported that patient did not have any problem with first one. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353208
Sex: F
Age:
State: WA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 05/27/2021
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: she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days; she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days; This is a Spontaneous report from a contactable consumer. This consumer reported for both mother and baby. This is a mother report. A 34-year-old non-pregnant female received first dose of BNT162B2 (Pfizer COVID vaccine, Lot number: unknown, expiration date: unknown) via an unspecified route on 29Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that my neighbor informed me through casual unsolicited conversation. At 6:30 PM Pacific, on 02Feb2021, my neighbor reported receiving the Pfizer COVID vaccine through her place of employment she was a pediatric nurse in the Emergency Department) on Friday 29Jan2021. She stated that on Saturday (30Jan2021) and Sunday (31Jan2021) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021). I do not know her exact date of birth, but I believe she was 34 years old. Although she was not currently pregnant, she was lactating, and was currently weening her 19-month-old son. Patient underwent lab test and procedure which included body temperature 101.4 Fahrenheit on 30Jan2021.The clinical outcome of the event was recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021153907 mother/baby

Other Meds:

Current Illness:

ID: 1353209
Sex: F
Age:
State: PA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 05/27/2021
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: 102.4 degree fever; severe chills; moderate fatigue; moderate headache; moderate muscle pain; mild pain at the injection site; This is a spontaneous report from a contactable 30-year-old female consumer reported for herself. A 30-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6201) via an unspecified route of administration in left arm on 12-FEB-2021 08:30AM as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history includes major depressive disorder and generalized anxiety disorder. The patient previously took first dose of bnt162b2 on 22Jan2021 at 05:45 pm (Lot #EL9262) on Left arm, for covid-19 immunisation. Concomitant medications within 2 weeks of vaccination included lexapro, ibuprofen, acetaminophen, diphenhydramine. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the same date of vaccination at 08:00 PM she had 102.4-degree fever, severe chills, moderate fatigue, moderate headache, moderate muscle pain and mild pain at the injection site. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Known allergies to medications, food, or other products were none. The clinical outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: LEXAPRO; IBUPROFEN; ACETAMINOPHEN; DIPHENHYDRAMINE

Current Illness:

ID: 1353210
Sex: F
Age:
State:

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 05/27/2021
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: low grade fever; sore arm; stiffness in the neck and back; stiffness in the neck and back/became very stiff my back, very pain; could not get warm although she had 3 dawn comforters on overnight; headache; horrible gastro-intestinal upset; nausea; vomitting; dry heaving; became very stiff my back, very pain; Gastrointestinal upset; I cannot drink water; cannot do anything; Fever; felt really horrible; been up for the whole night; I just tremble; dry heat; I just do not feel well that is severe; I have been sick all night; terrible chills; began to get very swarthy injection site; shivering; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 for COVID-19 immunization and experienced low grade fever, sore arm and felt little sore. On an unspecified date, patient experienced low grade fever, sore arm, began to get very swarthy injection site, stiffness in the neck and back/became very stiff her back, very pain, headache, terrible chills, could not get warm although she had 3 dawn comforters on overnight and was just shivering then in the middle of night woke up vomiting and went this nausea and horrible gastro-intestinal upset, dry heaving, cannot drink water, cannot do anything, fever, felt really horrible, been up for the whole night, patient just tremble, dry heat, patient just did not feel well that was severe and patient had been sick all night. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353211
Sex: M
Age:
State: NJ

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 05/27/2021
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: Some mild body aches; I had a low grade fever; Headache; This is a spontaneous report from a contactable Consumer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, in left arm on 10Feb2021 13:45 as 2nd dose, single for covid-19 immunisation and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, in left arm on 20Jan2021 01:15 PM as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks previous to the COVID vaccine. Facility type vaccine was workplace clinic. Prior to vaccination, patient became now not diagnosed with COVID-19. On 11Feb2021 at 07:00 AM when patient woke up the next morning, he had a low-grade fever, some mild body aches and a headache. He took Tylenol as needed during the day and worked from home instead of going into the office. By the following morning (12Feb2021) he felt fine. The outcome of the events was recovered on 12Feb2021.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm