VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1436781
Sex: M
Age:
State:

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (reporters father). A 60-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for covid-19 immunization (60 year at the time of vaccination). The patient medical history and concomitant medications were not reported. On 26Mar2021, the patient experienced injection site pain. And the reporter wanted to know if the patient can take Tylenol/ibuprofen. The outcome of the was reported as unknown at the time of report. No follow-up attempts are possible. No information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1436782
Sex: F
Age:
State: HI

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 06/30/2021
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: pain in injection site arm; This is a spontaneous report received from a non-contactable consumer, the patient. A 67 years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via an unspecified route of administration in the left arm on 13Mar2021 at 11:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included Type II diabetes mellitus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 13Mar2021 after 6 hours of vaccination, the patient experienced very slight pain in injection site arm. The patient did not receive any treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the pain in arm was resolved on 14Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436783
Sex: F
Age:
State:

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 06/30/2021
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: Left leg felt heavy; left leg felt tingly; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to levofloxacin (LEVAQUIN). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 18Mar2021, the patient experienced heaviness and tingling in the left leg that corresponded to the arm where the shot was received for 5 days after the vaccine. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of heaviness and tingling in the left leg were resolving. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1436784
Sex: F
Age:
State: CO

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 06/30/2021
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: I experienced rapid onset of atopic dermatitis on my thighs and underarms; This rash has since spread across my torso and up my neck over the course of 4 days; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 4 hours post-vacc: headache, fatigue 9 hours post-vacc: headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours.; 14 hours post-vacc: body aches, headache 30 hours post-vacc: all adverse events ceased except slight soreness at injection site (normal).; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 28years old (at the age of 28-years-old) non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP6955) via an unspecified route, administered in left arm on 24Mar2021 11:00 as dose 2, single for COVID-19 immunization. The patient medical history included, generalized anxiety disorder, post-traumatic stress disorder (PTSD), anxiety and allergy to erythromycin. The patient concomitant medications included prazosin 1mg/day, sertraline 100mg/day within 2 weeks of vaccination. The patient had not received any other vaccines received within 4 weeks prior to vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248) via an unspecified route, administered in Left Arm on 03Mar2021 at 17:00 as a dose 1, single for COVID-19 immunization. On 24Mar2021 at 15:00 (4 hours after second dose of vaccination), the patient experienced headache, fatigue. After 9 hours she experienced headache, fatigue, fever, chills, minor nausea. Serious chills/shaking lasted 4 hours. After 14 hours, she had body aches, headache. After 30 hours all adverse events ceased except slight soreness at injection site (normal). The patient took Ibuprofen to mitigate fever/aches. On 26Mar2021 at 19:00 (60 hours post-injection of dose2), she experienced rapid onset of atopic dermatitis on her thighs and underarms. This rash had since spread across her torso and up her neck over the course of 4 days (3/26-3/30) and was ongoing. She was seeking care via a dermatologist. Since the vaccination, the patient had not been tested for COVID-19. The adverse event atopic dermatitis on her thighs and underarms resulted to visit doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment medications for atopic dermatitis on my thighs and underarms and rash. The patient did not received any treatment medication for resulted events other than soreness at injection site. The outcome of the event atopic dermatitis on her thighs and underarms and Vaccination site pain, this rash has since spread across my torso and up my neck over the course of 4 days was not recovered and the outcome of other events was recovered on unspecified date in 2021. The seriousness of the events was reported as non-serious. No Follow-up attempts are needed. No further information was expected.

Other Meds: PRAZOSIN; SERTRALINE

Current Illness:

ID: 1436785
Sex: F
Age:
State: MD

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 06/30/2021
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: FACIAL TIC RIGHT BELOW THE RIGHT EYE; Injection site pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 50-years-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, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in arm right on 25Mar2021 at 11:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient not had any allergies to medications, food, or other products. The vaccination facility type was reported as pharmacy or drug store. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. 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 and had not tested for COVID-19, since the vaccination. On 25Mar2021 at 16:00, the patient experienced injection site pain. On 26Mar2021 at 07:30, experienced facial tic right below the right eye. The treatment was not received for the event. The events were reported as non-serious. The outcome for the event injection site pain was resolving while other event facial tic right below the right eye was reported as resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: JUNEL; LEVOTHYROXINE SODIUM

Current Illness:

ID: 1436786
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/01/2021
Rec V Date: 06/30/2021
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: skin rash/rash; swollen lymph nodes/swollen lymph nodes on my right neck; has a bruise on the back of her neck or like her muscle got hurt; has a bruise on the back of her neck or like her muscle got hurt; asthma/allergic asthma; ear hurts; Shingles; This is a spontaneous report from a contactable consumer(patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 08:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Allergic asthma from an unknown and was ongoing. The patient concomitant medications were not reported. The patient with a history of allergic asthma who received the first dose of the COVID19 vaccine on (Monday) on 22Mar2021 at 8 AM. About 8 hours later around 3 PM (Monday) on 22Mar2021 she started to start felling some asthma /Asthmatic, like dealing with bad allergies because she has allergic asthma. It just got like she had dealing bad allergies. Not bad, but similar to when she is exposed to a lot of dust. She took her spray as she periodically took it. On (Wednesday) on 24Mar2021 (36 hours after), she noticed a skin rash and swollen lymph nodes on the right side of her neck, which was the opposite side of where she got her shot, she got shot on the left side on her arm. It feels like she has a bruise on the back of her neck or like her muscle got hurt. Sometimes her ear hurts too. She got the vaccination on her left side. She doesn't know if this was fairly typical or not. She was uncertain if she should get the second dose because she heard second shot is worse. The patient received the treatment spray for asthma. She has rash and swollen lymph still and she was wondering is it safe for me to take second dose giving that she has have this symptom. She saw Doctor on Friday (26Mar2021) and she told her that she got shingles, the rash, it turned out to be Shingles. She asked has a lot of people reported shingles. Her second dose scheduled for 12Apr2021. The outcome of skin rash/rash and swollen lymph nodes/swollen lymph nodes on my right neck was not resolved. The outcome of asthma/allergic asthma has a bruise on the back of her neck or like her muscle got hurt, ear hurts, shingles was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Allergic asthma

ID: 1436787
Sex: F
Age:
State: NY

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: Metallic taste and smell after second dose; Metallic taste and smell after second dose; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 17-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 09:30 (age at vaccination 17-year-old), single dose for covid-19 immunisation. The patient's relevant medical history included vasovagal syncope and Covid-19. The patient did not have any known allergies. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL). The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6203) on 05Mar2021 at 12:00 via an unspecified route of administration in left arm at single dose for covid-19 immunization. Prior to vaccination patient was diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Since the vaccination, the patient had not been tested for COVID-19. Reporter stated that patient texted her that, on 26Mar2021 at 09:30, after getting her second dose, she had metallic taste (tasted metal in her mouth) and smell. Patient did not receive any treatment for the adverse event. The outcome of event was recovering at the time of reporting. No Follow-up attempts are needed. No further information is expected.

Other Meds: JUNEL

Current Illness:

ID: 1436788
Sex: F
Age:
State:

Vax Date: 03/22/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: dizzy; nauseous; slight fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On 26Mar2021, patient woke up very dizzy, nauseous and had a slight fever. Patient asked that considering that it is 5 days after, should she be concerned that she contracted COVID-19 before getting vaccinated. Outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436789
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: my lip, face and neck is swelling up little; my lip, face and neck is swelling up little; my lip, face and neck is swelling up little; This is a spontaneous report received from a contactable consumer, the patient. This consumer reported similar event for 2 patients. This is the 1st of two reports. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported, Solution for injection), 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 an unspecified date, patient got the first dose of the Pfizer vaccine and his lip, face and neck were swelled up little. He did not fell short of breath. He asked, what he can do for his second dose that comes next Tuesday, 31Mar2021. There were some other patients who reported some symptoms the same as this. He was afraid with the second dose that it will give him a stronger reaction. The outcome of events 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-2021337093 Same reporter/ drug/ event for different patients

Other Meds:

Current Illness:

ID: 1436790
Sex: F
Age:
State: NY

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: Fatigue; Flu-like symtoms; This is a spontaneous report from a contactable consumer (patient, reported for self). A 39-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Not reported), via an unspecified route of administration, administered in the left arm on 26Mar2021 15:00 (at 03:00 PM) (at the age of 39-years-old) as dose 2, single in left arm for COVID-19 immunization. Patient had no allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Not reported), via an unspecified route of administration, administered in the left arm on 04Mar2021 (03:00 PM) as dose 1, single for COVID-19 Immunization. Prior to vaccination, patient was not diagnosed with COVID-19 prior to the COVID vaccine. No other medical history reported. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 07:00 AM patient experienced fatigue, and flu like symptoms. Adverse event did not result in Physician office visit or emergency visit. Patient had received treatment for the adverse events which included acetaminophen. Since the vaccination the patient has not been tested for COVID-19. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436791
Sex: M
Age:
State:

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 06/30/2021
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: don't feel well today; nauseous; vomiting; fatigue; sore arm; This is a spontaneous report from a contactable consumer. A (Age: 65, Unit: Unknown) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 23Mar2021 (Tuesday) at 14:30 as 1st dose, single for COVID-19 immunization. No medical and concomitant medication history were reported. On 24Mar2021, the patient experienced a little bit of fatigue and a pretty sore arm. On 26Mar2021, the patient was feeling nauseous and vomiting. Caller stated that he was not really up to filing a report as he was not feeling well and he just wanted to know if this was normal and if it may be related to the vaccine. Caller stated that would be three days or 72 hours since he got the vaccine at 14:30. The outcome of the events were unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436792
Sex: F
Age:
State: NJ

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 06/30/2021
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: get tested for COVID-19 on 21 March 2021. She said she got her result the following day, Monday, and tested positive; couldn't swallow; stuffy nose/stuffy, runny nose and cough; stuffy nose/stuffy, runny nose and cough; stuffy nose/stuffy, runny nose and cough; general aches and pains; couldn't smell; couldn't breath; arm pain and felt tired/left arm pain, tender to touch; arm pain and felt tired/left arm pain, tender to touch; arm pain and felt tired/left arm pain, tender to touch; post-nasal drip; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EN6206), via an unspecified route of administration in left arm on 12Mar2021 at 15:30 (at the age of 47-year-old) as single dose for COVID-19 immunization. Patient got the Pfizer COVID19 vaccine because she wanted to be able to go to work and be around the kids. She states she wanted it for protection and that she wants her family to get it, so she wanted to be the first to go through with getting it. Medical history of the patient included heavy periods, anemia and allergies. Family Medical History included dad diabetic and both parents have heart issues and high blood pressure. Concomitant medications included iron, multivitamin, ergocalciferol (Vitamin D) and ascorbic acid (Vitamin C) daily, but patient declines to go through any details for the report, patient started taking Tranexamic Acid on 24Mar2021 and was ongoing [650mg one tab by month 3x day for first five days of menstrual cycle] due to history of heavy periods. The patient previously received her last shot and states maybe a tetanus shot or an epidural when she was pregnant. Also, mentioned that she doesn't get shots much. On 12Mar2021, after vaccination, by the time patient got home she was tired and took a nap. The patient experienced her arm was a little sore to the touch, when patient got home she put an icepack under her arm and took a nap. The patient stated she slept from about 19:30 until around 03:00 on 13Mar2021. Patient ate a bowl of cereal, took 2 extra strength Tylenol and went back to sleep until about noon on the 13Mar2021. When she woke up her tiredness was gone on 13Mar2021. As per patient Tylenol she took was effective. The patient stated that over the course of the weekend, she took 2 extra strength Tylenol twice and does feel like it was effective. The patient stated that her arm soreness was resolved by 16Mar2021. The patient reported that she could not smell since the 14Mar2021 which she attributed to her stuffy nose. On 15Mar2021 she started to get a stuffy, runny nose and cough, she attributed it to her allergies and change in weather, she normally has allergies. She went to work, she felt fine. Patient took some Allegra and her multivitamin. Patient stated from 15Mar2021, she was experiencing general aches and pains in her shoulders and back of neck. Patient was not sure if it was from her sitting at her desk at work or from the COVID19 virus. The patient had these aches prior to testing positive for COVID or even getting the Pfizer COVID19 vaccine, but she thought that it may be exacerbated by all of this. On 18Mar2021, the patient had worst day for her symptoms, stating she couldn't breath, couldn't smell, couldn't swallow. On 18Mar2021, she called her doctor. Her doctor prescribed her a zpack and Singulair for at night and a nasal spray. The patient felt like these were effective stating Z packs always work and make patient feel better, it was working. Patient explained that around the "15,16,17" Mar2021, she felt like "allergy" symptoms. She described them as a "loss of [her] sense of smell which she attributed to of [her] difficulty breathing; stuffy nose; and post-nasal drip". During this time she was still going to work. She notes that between the 14Mar2021-18Mar2021 she couldn't smell but she attributed this to the stuffy nose. She could smell fine now. Patient mentioned that her son started to get runny nose and cough symptoms, so she decided to go and get tested along with her son on 21Mar2021. Patient had a PCR test and following day, Monday, it came back positive. The patient was told to quarantine for 10 days since the onset of the symptoms. Patient would mean her quarantine was up on the 28Mar2021 or 29Mar2021, but she states she will probably continue quarantining until the 31Mar2021.The patient stated she was scheduled for her second Pfizer COVID19 vaccine on 30Mar2021, but she canceled it due to her positive COVID19 status and she doesn't think she should get the shot one day after getting out of quarantine. The patient doctor told her that she should wait 30 days to get her next vaccine which would be 18Apr2021 or 19Apr2021 but the doctor at the Urgent care told her she should wait 90 days. Patient asked what she should do. Patient does live with her son who developed symptoms after patient; both tested positive for COVID 19. Treatment included 2 extra strength Tylenol, allegra, zpack and Singulair for at night and a nasal spray. Outcome of the events arm pain, tender to touch was resolved on 16Mar2021, tiredness was resolved on 13Mar2021, couldn't smell, couldn't breath was resolved on 18Mar2021, for stuffy nose/stuffy, runny nose and cough, general aches while pain were not resolved and for COVID and couldn't swallow was unknown. No follow-up attempts are possible. No further information about lot/batch number cannot be obtained.

Other Meds: IRON; VIT D; VIT C

Current Illness:

ID: 1436793
Sex: F
Age:
State: PA

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 06/30/2021
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: I did have a sore arm for several days after the 2nd dose; This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 53-year-old) as dose 2, single for COVID-19 immunization. The patient received first dose of BNT162B2 (Lot number: EN6199, Expiration date: unknown) via an unspecified route of administration, administered in Left arm on 03Mar2021 at 13:30 (at the age of 53-year-old) as unknown dose for COVID-19 immunization. Historical vaccine included Cortisone shot on 01Mar2021 for arthritis: she got a cortisone shot in her hip two days before the first dose. The patient medical history was not reported. Family Medical History reported as None. Concomitant medication(s) include olopatadine hydrochloride (OLOPATADINE HYDROCHLORIDE OD) taken for seasonal allergies as one spray into each nostril, two sprays a night for taking it for 3-4 years; fexofenadine hydrochloride (ALLEGRA); fish oil (FISH OIL) ongoing; glucosamine sulfate (GLUCOSAMINE [GLUCOSAMINE SULFATE]) ongoing; curcuma longa root (TURMERIC CURCUMIN) ongoing; ginkgo biloba (GINKGO BILOBA PLUS [GINKGO BILOBA]) ongoing; collagen (COLLAGEN) ongoing; diphenhydramine hydrochloride (BENADRYL) ongoing; biotin (BIOTIN) ongoing. The other vaccine in four weeks was reported as none. The patient previously took minocin and codine for known allergies. Prior Vaccinations (within 4 weeks) reported as None. The patient not had COVID-19 prior vaccination; not tested COVID-19 post vaccination. Consumer stated that she got a cortisone shot 2 days before the first COVID-19 and she had a sore arm for several days after the 2nd dose and she heard from her mother's doctor that she should not get a cortisone shot within 2 weeks before or after the COVID shot because it might prevent the formation of antibodies. Her doctor did not tell her that. With the first shot she had absolutely no reaction, not even a sore arm. Just for a couple days, nothing much but at least she knew she got a shot. Now she was worried and wanted to know regarding the first shot, did the cortisone shot make the first shot ineffective. She stated that she got a cortisone shot in her hip two days before the first dose. States her mother went to get a cortisone shot on her knuckles, and she had both doses of the Moderna vaccine, and her doctor told her that she might not want to get her cortisone shot because it could affect the efficacy of the vaccine and she may opt to wait on her cortisone shot. Consumer stated that her mother told her that and caused her to panic. Her mom came home and told her that she didn't get her shot, her fingers are killing her but she didn't think it was worth the risk. She was referring to her mom not receiving the cortisone shot since she had the Moderna COVID vaccine per the doctor's suggestion. Consumer stated that the morning after her second dose around 8 am on 25Mar2021 she woke up with a sore arm. She states with the first dose she did not experience nothing, states not even slight soreness where they gave her the shot if she pressed on it. She Clarified that she got her cortisone shot on 1Mar2021, two days before she got her first dose. States she was freaking out a little bit. She states first dose was given at 1:30 pm EST. Second dose was given between 1:15-1:30 pm. Consumer stated that she started taking allergy shot give or take 10 years ago, could be more. On 25Mar2021 at 08:00, the patient experienced i did have a sore arm for several days after the 2nd dose. The patient did not receive any treatment for the events. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: OLOPATADINE HYDROCHLORIDE OD; ALLEGRA; FISH OIL; GLUCOSAMINE [GLUCOSAMINE SULFATE]; TURMERIC CURCUMIN; GINKGO BILOBA PLUS [GINKGO BILOBA]; COLLAGEN; BENADRYL; BIOTIN

Current Illness:

ID: 1436794
Sex: F
Age:
State: NY

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 06/30/2021
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: Fever; severe headache; body aches; exhaustion; This is a spontaneous report from a contactable Health care professional. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:45 (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included (Since Childhood), Sessional envirmental Allergies, Casein Allergy from an unknown date and unknown if ongoing. Patient's historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm left on 31Dec2021 (Batch/Lot Number: EL0142) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) 150 Mg orally Daily taken for hypersensitivity from an unspecified start date and ongoing; nifedipine 30 Mg orally Daily taken for hypertension from an unspecified start date and ongoing; montelukast sodium (SINGULAIR) 10 Mg orally Daily taken for asthma from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol from Sep2019 and ongoing. The patient experienced fever, severe headache, body aches, exhaustion on 22Jan2021 21:00. The patient underwent lab tests and procedures which included body temperature: 103 degree F on 103 degree F. Therapeutic measures were taken as a result of fever, severe headache, body aches, exhaustion (Tylenol: 1000 mg orally (31Dec2021) and Ibuprofen). Hx of Vitiligo reaction after fw Vaccine 10 hrs ago, Vitiligo appearal where bondaid adheoine contacted skin. Bandaid first removed for approx. 24 hrs. Post vaccine vitiligo remained for 4 months then resolved. Outcome of event s was resolved on unspecified date in 2021. additional information has been requested Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds: ALLEGRA; NIFEDIPINE; SINGULAIR; ATORVASTATIN

Current Illness:

ID: 1436795
Sex: M
Age:
State: AL

Vax Date: 03/25/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: caller had a bad and painful headache; This is a spontaneous report from a contactable consumer (patient himself) and via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Mar2021, the patient experienced had a bad and painful headache. Patient had the first dose of the Pfizer COVID-19 vaccine last night, he had a bad and painful headache,woke up with a headache this morning. He wanted to know if he could take ibuprofen and what should he do for the headache. He would like to know how to get rid of his headache. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436796
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: A burning sensation as it went in/ got the second one and it burns; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), via an unspecified route of administration on about 3 and half weeks ago in 2021 (Batch/Lot number was not reported) as single for covid-19 immunization and patient was fine. Patient stated that she got the Pfizer COVID-19 vaccine a month ago. She said the first shot was fine but with the second one, she felt a burning sensation as it went in on an unspecified date in 2021. She wanted to know if the first and second dose of the vaccine are exactly the same and if not, what could have caused the burning sensation and she told her experience with each of the doses. Everything was set-up during her first dose appointment. During her second dose, the lady was running back and forth with the vaccine and it kind of struck her for being odd. She thinks something must've screwed up that's why she felt the burning sensation. Patient also stated she got the first Pfizer vaccine about 3 and half weeks ago, didn't feel the same, got the second one and it burns as it went in and she wanted to know what was the difference between the first and the second and what could have caused that. The outcome of the event was unknown. No follow-up attempts are possible; Information about Lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1436797
Sex: M
Age:
State: TN

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 06/30/2021
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: swollen lymph node under his left arm; tenderness at the injection site/his arm was tender; felt like he got light-headed was going to pass out; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GR2613, expiration date: not reported), via an unspecified route of administration, administered in arm left (left upper arm, around his shoulder area) on 24Mar2021 19:00 as dose 1, single for COVID-19 immunisation (reason for vaccination: at his age, he had elder parents and grandkids and he wanted to protect himself and protect others). The patient's medical history was none and concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine, no additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. No family medical history relevant to adverse events. On 25Mar2021 (yesterday) he felt fine, but he felt a tenderness around the injection site. The patient stated that he had tenderness at the injection site on 25Mar2021 (yesterday). On 26Mar2021 (this morning) his arm was tender, and he noticed a swollen lymph node under his left arm, in which the node was the reported as the size of a baseball. He had received the vaccine in the left arm. On 26Mar2021 (this morning) whenever he got out of the shower, he noticed his lymph node underneath his arm was swollen and tender. He started rubbing it and then he felt like he got light-headed was going to pass out (start: unspecified date in 2021). Tenderness around the injection site felt a lot better on 26Mar2021 (today) than it did yesterday, and it was just a little tender today. His lymph node was very tender, and it was not that bad, until he started rubbing on it, then it went down-hill after that. No physician office, no emergency room visit. He was asking if this was normal and if this was something that should go back down in 2 or 3 days and if he should get this looked at by a doctor and will the swollen lymph node go down. The outcome of tenderness at the injection site was recovering, light-headed was unknown, swollen lymph node under his left arm was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1436798
Sex: F
Age:
State: NY

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 06/30/2021
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: have got a little bit of infection on it.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration on 08Mar2021 as dose 1, single (age at vaccination 75 year old) for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation, emphysema from an unknown date (Emphysema and AFib. Yes, I have COPD or Emphysema and AFib with my heart, Atrial fibrillation). Concomitant medication included CEFALEXIN [CEFALEXIN SODIUM] 500mg twice daily, rivaroxaban (XARELTO) 50mg once daily, tiotropium bromide (SPIRIVA) 18ug, once daily, ciprofloxacin hydrochloride (CIPROWIN [CIPROFLOXACIN HYDROCHLORIDE]) 75 mgs 2 tablets a day. The patient have got a little bit of infection on it on an unspecified date. She was scheduled to receive the second dose of Pfizer BioNtech Covid 19 vaccine this Monday (confirmed as 29Mar2021) coming up and she reports that she had been on Cefalexin for a week now this entire week and her dose was going to be this Sunday and she was just calling to see if it was okay to get second dose of the vaccine but patient got her over here to report it the use of that medication. patient did not want to go if the antibiotic was going to interfere with the potency of the shot. The patient underwent lab tests and procedures which included minor surgery resulted to infection on an unknown date. Therapeutic measures were taken as a result of have got a little bit of infection on it which includes CEFALEXIN. The clinical outcome for the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: CEFALEXIN [CEFALEXIN SODIUM]; XARELTO; SPIRIVA; CIPROWIN [CIPROFLOXACIN HYDROCHLORIDE]

Current Illness:

ID: 1436799
Sex: F
Age:
State: MD

Vax Date: 03/06/2021
Onset Date: 03/25/2021
Rec V Date: 06/30/2021
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: arm soreness; joint pain; Malaise; 19 to 20 days post 1st vaccine fever; chills; extreme fatigue; shortness of breath; pain when taking a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6204; Expiration Date: 03Jun2021), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, polymyalgia rheumatica. Patient is allergic to clindamycin, fortaz, sulfa. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested positive since vaccination. Patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications received in two weeks was reported as too many to list. On 25Mar2021 06:00, 19 to 20 days post 1st vaccine, the patient experienced fever, chills, extreme fatigue, shortness of breath, pain when taking a deep breath. On an unknown date patient experienced arm soreness, joint pain, malaise. Consumer stated that she was not sure if she was experiencing side effects from her vaccine or not which is why she didn't go to the website. she was wondering if you are seeing any cases of 3 weeks out 24 hours of fever, malaise, fatigue. she was supposed to get her second one tomorrow and she was feeling better now, but yesterday she was running a 100 temperature, she had joint pain and it just knocked out, it was about 24 hours and now its over. When confirmed that the consumer wanted to know about the side effects from the COVID 19 Vaccine, consumer stated that Yeah, have you heard about that. When confirmed if the consumer had any side effects from the first shot, consumer stated that she was not sure if this is or not, all she had was some arm soreness and fatigue directly from the first vaccination. This is almost 3 weeks and she had this almost 24 hour thing just out of nowhere. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Mar2021, fever: 100 on 25Mar2021. Therapeutic measures were taken as a result of events included antibiotics and steroids. The outcome of the events were recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436800
Sex: F
Age:
State: IL

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 06/30/2021
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: Fever 104 solid; extreme exhaustion / body fatigue; Chills/sweats; Point of injection is sore with some bruising; armpit muscle extremly sore; Point of injection is sore with some bruising; Fever 104 solid with constant intense ringing in the head; Chills/sweats; This is a spontaneous report received from contactable consumer (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK5730), via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 03:45 PM (at the age of 47-year-old) as single dose for covid-19 immunisation at clinic. Medical history included allergy to sulfa drug from an unknown date and unknown if ongoing and other medical history reported as none. The patient's concomitant medications were not reported. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EJ1685), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 01:15PM as single dose for covid-19 immunisation at clinic. Prior to vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient was not tested for covid-19. Patient did not receive any other vaccine four weeks prior of vaccination and any other medication two weeks of vaccination. On 23Mar2021 at 09:00 PM, the patient experienced fever 104 solid with constant intense ringing in the head, chills/sweats, extreme exhaustion/body fatigue, point of injection is sore with some bruising and armpit muscle extremely sore. Patient visited to healthcare professional office/clinic for the events. No therapeutic measures were taken because of the events. The outcome of the events was reported as recovering.

Other Meds:

Current Illness:

ID: 1436801
Sex: F
Age:
State: NY

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 06/30/2021
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: felt very tired with first dose; headache with first dose; bruised sore in the musculature; bruised sore in the musculature; musculature from the shoulder to almost elbow was very sore; nausea/a little bit of nausea with the first dose; low level fever up to 100/low grade fever after first dose; sore/achy; arm extremely sore after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 around 3-4 PM (at the time of vaccination 69-years-old), as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included Allergies, and physical injury that happened 3 years ago. The patient's concomitant medications were not reported. Historical vaccine included Flu Shot on an unspecified date in Oct 2020 and patient previously took tetracycline and she experienced allergy to tetracyclin (hasn't taken in 25 years). On 24Feb2021, the patient experienced sore/achy and arm extremely sore after first dose, on 25Feb2021 low level fever up to 100/low grade fever after first dose, on 26Feb2021 nausea/a little bit of nausea with the first dose, on an unspecified date felt very tired with first dose, headache with first dose, bruised sore in the musculature, and musculature from the shoulder to almost elbow was very sore. Patient states she took Tylenol and aspirin for low level fever up to 100/low grade fever after first dose. The seriousness of the events was reported as non serious. The outcome of an events sore/achy, arm extremely sore after first dose resolved on 10Mar2021, low level fever up to 100/low grade fever after first dose resolved on 04Mar2021, nausea/a little bit of nausea with the first dose resolved on 01Mar2021 and other events was reported as unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436802
Sex: F
Age:
State: MI

Vax Date: 03/19/2021
Onset Date: 03/25/2021
Rec V Date: 06/30/2021
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: Lower lip swelling; This is spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received BNT126B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), administered in right arm on 19Mar2021 01:15 PM as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Age at vaccination was 53-year-old (reported as 53).The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications received within two weeks of vaccination included gabapentin, sertraline and levothyroxine, all from unspecified date. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM), from unspecified date and it was reported as known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 the patient experienced lower lip swelling. No treatment was received for the event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not resolved. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: GABAPENTIN; SERTRALINE; LEVOTHYROXINE

Current Illness:

ID: 1436803
Sex: F
Age:
State: TX

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 06/30/2021
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: Fever; Chills; Body Aches; Sweating; Fatigue; Insomnia; Sensation of pounding heart (could feel heart beat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot Number: ER8727) via an unspecified route, administered in Left Arm on 23Mar2021 at 10:15 AM (34-year-old at vaccination) as single dose for covid-19 immunization. The patient's medical history included heart murmur and occasional anemia. Allergies to medications, food, or other products was reported as none. The patient's concomitant medications were reported as none within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 22:30, the patient experienced fever, chills, body aches, sweating, fatigue, insomnia, sensation of pounding heart (could feel heartbeat), lethargy. The events began 12hrs after 1st dose, and latest for 3 days, but still battling fatigue even after mild activity. Since the vaccination, has the patient was not been tested for COVID-19. No treatment received for resulted adverse events. The outcome of the event fatigue was not recovered, and the outcome of other events was resolving. Follow-up activities closed. No Further information is expected.

Other Meds:

Current Illness:

ID: 1436804
Sex: F
Age:
State:

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 06/30/2021
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: diarrhea; This is a spontaneous report from a non-contactable consumer or other non hcp. This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced diarrhea (non-serious) on an unspecified date with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436805
Sex: F
Age:
State: MS

Vax Date: 03/23/2021
Onset Date: 03/01/2021
Rec V Date: 06/30/2021
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: ear infection; feeling off balanced where it was really bad this morning; sore arm; This is a spontaneous report from a contactable consumer reporting for herself via Pfizer sponsored program. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 23Mar2021 (at the age of 64-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included that she had ear disorder (ear problems) for a while now and had ear surgery in her left ear, immunodeficiency (immunocompromised), blood immunoglobulin g increased and blood iron increased from an unknown date and unknown if ongoing. Concomitant medication(s) included immunoglobulin g human (IGG) taken for immunodeficiency; ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); atorvastatin calcium (AVAMAX) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 for COVID-19 immunisation. The patient experienced ear infection, feeling off balanced where it was really bad that morning, sore arm on unspecified date in Mar2021. Patient was asking when she could take steroids and antibiotic eardrops for an inner ear infection. This caused her concern because she had been feeling off balanced where it was really bad, the morning of this report. She mentioned that she experienced this right after the shot, and it lasted for a while and went away. She also mentioned that she had ear problems for a while now and had ear surgery in her left ear. She is not associating the symptoms she has been experiencing with the vaccine and is saying that it is most likely the ear infection. She mentioned that she just had a sore arm after getting vaccinated and denied any fever and chills afterwards. She mentioned that she is immunocompromised but claims that her immune system as well as she gets IgG infusions every night and takes vitamins C and D regularly. Her IgG and iron were up because of it. She was also taking Avamax. She mentioned that she has been in bed the whole day and that she was able to clean the house yesterday. She mentioned that she felt better and safer after getting vaccinated and felt that she had a better chance. It was reported that patient was associating her symptoms to the vaccine. Additional follow-up on 27Mar2021, reported that patient would like to ask if she can continue to take her prescribed medication such as steroids and antibiotic drop on her ear. Clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: IGG; VITAMINS C; VITAMIN D [COLECALCIFEROL]; AVAMAX

Current Illness:

ID: 1436806
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 06/30/2021
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: active infection/the spot was infected; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (Husband). A male patient of an unspecified age received first dose of 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 dose 1, single for covid-19 immunization. Medical history included had a spot on his chest. The patient's concomitant medications were not reported. The patient experienced active infection/ spot was infected on 22Mar2021. Reporter and husband both had 1st dose of the Pfizer Covid 19 vaccine with 2nd dose due on 26Mar2021 (Friday). Prior to receiving 1st shot, husband had a spot on his chest which was removed after receiving 1st shot. After removal yesterday the spot was infected. Reporter would like to know if husband can receive the 2nd Covid vaccine on Friday with an active infection and while taking medication. Therapeutic measure was taken as result of event, unspecified medication. 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: 1436807
Sex: M
Age:
State: PA

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 06/30/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: This is a spontaneous report from a contactable consumer. A 52-year-old male patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 27Mar2021 17:00 (at the age of 52-year-old) as dose 1, single for covid-19 immunisation. Medical history and known allergies were reported as no. Concomitant medications included atorvastatin (LIPITOR), amlodipine (NORVASK), omeprazole (PROTONIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Lipitor, Norvask, Protonix. The patient experienced fever 101 on 28Mar2021 at 12:00. Seriousness of the event was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The patient did not have covid prior to vaccination and has not been tested for Covid-19 post vaccination. The patient did not receive any treatment for the adverse event. The outcome of event was recovered on an unspecified date of 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: LIPITOR [ATORVASTATIN]; NORVASK [AMLODIPINE]; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1436808
Sex: F
Age:
State:

Vax Date: 03/16/2021
Onset Date: 03/17/2021
Rec V Date: 06/30/2021
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: Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between boobs that was very heavy; Angry; Chills/shivering; cold; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), intramuscular, administered in Arm Left on 16Mar2021 (at the age of 50-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 17Mar2021 the patient experienced headache, aches, coughing, feels weak and powerless, chest pain between boobs that was very heavy, angry, chills/shivering, cold. On 22Mar2021 the patient experienced positive for covid. On an unknown date the patient experienced crying. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021. The outcome of the events positive for covid, aches, cold and crying was unknown, for the event chest pain between boobs that was very heavy the outcome was resolved on 19Mar2021, for rest of the events the outcome was resolving. Description of complaint: Patient received Pfizer COVID vaccine on 16Mar2021 and tested positive for COVID on 22Mar2021. Processing complaint for LOE as per verbatim not clear after first shot or second Covid positive. No correspondence as reporter information not provided. Reporter, his wife, son and daughter all received the Pfizer COVID vaccine. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6206 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product lot EN5327. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1436809
Sex: M
Age:
State: TX

Vax Date: 03/26/2021
Onset Date: 03/01/2021
Rec V Date: 06/30/2021
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, second vaccine; Thirsty, second vaccine; spitting up green phlegm; Felt weird, felt bad, felt horrible, second vaccine; left side of his body was very sweaty; Chills, second vaccine; sneezing; headache; stuffy nose; loss of smell; Felt knocked out; fatigue, Tiredness; Sleepy, sleepiness, slept for very long hours, second vaccine; Nose running; Sinuses, stopped up, second vaccine; Aches, second vaccine; Did not eat much; he was shaking; coughing; weakness; pain to his left arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 26Mar2021 at 10:00 AM to 10:30 AM as a dose 2, single for COVID-19 immunisation. No family medical history relevant to ae(s). The patient's medical history included prostate and bronchitis, the caller stated that, he had a history of Bronchitis since he was small. The Bronchitis was worrisome with bad weather and a month prior there was bad weather and he had the chills. Past drug event included Tamsulosin for prostate, started about a year and a half ago for his prostate 0.4mg capsule, once a day and Finasteride for prostate, started about a year and a half ago for his prostate 5mg tablet, once a day. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration in the left upper shoulder on 05Mar2021 at 11:00 AM to 11:30 AM as a dose 1, single for COVID-19 immunisation. The patient's concomitant medications were not reported. Prior vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as no. Age at time of vaccination was 52 years. Enquired, the caller was a 53 y/o male. The patient received his first Pfizer Covid dose on 05Mar2021 and his second dose on Friday, 26Mar2021. The first and second vaccine both were given in the left upper shoulder. Stated that, his job offered to schedule his vaccines. After his second dose he developed pain to his left arm, which resolved on 28Mar2021. Stated that, on 26Mar2021, he sat down for 10 minutes after the dose and then drove home. Stated that, he drove the home on streets instead of the highway in case he started feeling bad so he wouldn't have to leave his vehicle on the highway. He kind of resisted being dizzy and sleepy, he was not that dizzy. The patient started feeling dizziness, fatigue, weakness a few hours after receiving the vaccine. Stated that, the second dose knocked him out. Stated that, he had a swift reaction about an hour after receiving his second dose, he was very tired, sleepy and sweating a lot and shakiness. The night he received the vacccine, he woke up at 3 AM and stated that, his left side of his body was very sweaty and he was shaking, coughing and sneezing. The patient reported that, a headache, stuffy nose and loss of smell. The patient wanted to know whether these were expected side effects. Response included referred to healthcare professional for further discussion and treatment recommendations. Informed the caller that, Pfizer cannot make treatment recommendations. It was reported that, the caller wanted to know whether the symptoms were immediate or took longer to effect someone after their second vaccine dose. Stated that, he knew everyone's reactions were different, he just wanted to know. Stated that, the patient was drinking a lot of water mixed with sprite to keep hydrated. The patient was sneezing a lot, had a stuffy nose, aches, fever but he could not find his thermometer. Stated that, he felt weird, bad, horrible and it hit him hard. Stated that, he did start to feel a lot better and on Saturday 27Mar2021, the patient thought he had improved. That morning he was ok to eat breakfast and able to smell his breakfast. In between 02:00 PM to 03:00 PM on Saturday, he was sleepy, slept very long hours, sweating on his left side a lot and some on right side of his body. On Friday and Saturday evening, the patient felt the same things, he was thirsty, sweating had chills all through night, was knocked out, had headaches, felt like the room was moving like in hyperspace, anytime he walked he felt like a guy on moon, like the ground was soggy underneath his feet. He stated he was not lethargic and kept his balance but like he was stepping on something soggy underneath him, he was dizzy. He had pain on his left side, his head, his arm as well and the left side of his face. The pain in his arm on Friday was so bad that he felt the pain in his face as well. The caller stated that, he had much less pain in his arm the next day on Saturday. Stated that, he heard the symptoms would start the next day after the shot. His nose was still stuffy. Stated that, the caller did not provide a healthcare professional for the report. Stated that, he had not seen a doctor for 10 years. The caller stated that, he was fine whether safety needed to clarify any documentation from the report. Stated that, his card does not have the Lot or Expiry date of the first dose and second dose. Stated that, with his first vaccine on 05Mar2021, he only had intense pain on his left side of shoulder, it was still there on Saturday and by Sunday the pain was much better. By Monday he was back to normal, only felt a little tired but not too much and he was able to do things. By Tuesday/Wednesday the patient was fine. The adverse events did not require a visit to emergency room and physician office. The reporter seriousness for other events was unspecified. Treatment received for the events was not provided. The relevant tests were reported as no. The outcome of the events pain to his left side was recovered on 28Mar2021 while for the other events was unknown. No follow-up attempts are needed, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436810
Sex: F
Age:
State: HI

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 06/30/2021
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: it felt like a really bad flu; feeling icky and chilly and cold and hot; sweating; Feeling cold and then hot; high blood pressure/Blood pressure was crazy; nausea; dizziness; chills; she woke up so sick.; Headache; Aches; sore arm/Soreness of arm; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534, Expiry date: Unknown) via an unspecified route of administration in Left arm on 25Mar2021 at the age of 67-years-old as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. On 25Mar2021, the patient experienced soreness of her arm, on 28Mar2021, experienced blood pressure was crazy, nauseous, dizziness, headache, aches, feeling cold and then hot, she woke up so sick and chills, on an unspecified date experienced it felt like a really bad flu, feeling icky and chilly and cold and hot and sweating. Caller reported that yesterday, 28Mar2021, her blood pressure went way high. Caller reported that yesterday, 28Mar2021, she tried to get up to go to the bathroom and was dizzy and nauseous. Caller reported that her blood pressure this morning, 29Mar2021 her blood pressure was still elevated. Caller reported that she got dizzy and nauseous again today, 29Mar2021, but that her blood pressure was ok when a second reading was taken. Caller reported that yesterday her headache was extreme and felt like her brain was going to blow off. Caller reported that one minute she would be feeling cold and the next minute she would be sweating. She reported that the day before on 28Mar2021, her blood pressure was crazy, she was nauseous, dizzy, and she thought her head was going to blow off. She reported that she stayed in bed and took aspirin the previous day on 28Mar2021. Caller reported that when she woke up this morning, 29Mar2021, she thought her headache was gone. Caller reported that she got up to go to yoga and thought she couldn't even get in the car to drive. The patient underwent lab tests and procedures which included Blood pressure: 172/106 on 28Mar2021 and 154/92 on 29Mar2021. The outcome of event, Soreness of arm was recovered on 27Mar2021 and for high blood pressure/Blood pressure was crazy, chills, sick, feeling icky and chilly and cold and hot, sweating was unknown and for other events was recovering. Batch/lot number was obtained. Further information has been requested.

Other Meds:

Current Illness:

ID: 1436811
Sex: U
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/18/2021
Rec V Date: 06/30/2021
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 felt a little tired; Dizzy; I got canker sores under my tongue and on my tongue and it hurt very much; I got canker sores under my tongue and on my tongue and it hurt very much; This is a spontaneous report from a non-contactable consumer (patient). A patient (unspecified age and gender) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation; potassium chloride (POTASSIUM CHLORIDE, 750 mg for an unspecified indication); chromium picolinate (CHROMIUM PICOLINATE, 200 ug and still ongoing for an unspecified indication); phentermine (PHENTERMINE, 37.5 mg and still ongoing for an unspecified indication); hydrochlorothiazide (HYDROCHLOROTHIAZIDE, 25 mg for an unspecified indication). Reported that patient stopped taking the Hydrochlorothiazide and I stopped the Potassium Chloride after 2 days because it made me dizzy. So I still take the Phentermine and the Chromium picolinate. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201), on 15Mar2021 as single dose for covid-19 immunisation and experienced Little tired on the 2nd day. Reported that two weeks before that I had the 1st one and all I felt a little tired on the 2nd day but I don't know if this canker sores are from the Pfizer. Reported that patient took two medicines on Monday and I started it on Monday so there is a 50-50 chance that is the medicine or the Pfizer. On 18Mar2021, the patient experienced i got canker sores under my tongue and on my tongue and it hurt very much, on an unspecified date, the patient experienced i felt a little tired, dizzy. It was reported that reporter seriousness for I got canker sores under my tongue and on my tongue and it hurt very much, I felt a little tired, Dizzy was unspecified. Reported that 4 days after my 2nd shot I got canker sores under my tongue and on my tongue and it hurt very much because canker sore hurt. But it is a possible side effect because it was 4 days after the 2nd one. Thursday I got this canker sores though and in addition I started taking some extra pills different pills so I don't know if those pills caused me to have the canker sores. So that's why I say possible side effects. The outcomes of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436812
Sex: F
Age:
State: NY

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 06/30/2021
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: sore,achy; allergic reaction; swollen glands; sore throat; fever up to 101F; face, ears, neck and chest turned bright red, very hot; face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish; nausea; Headache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 17Mar2021, as dose 2, 0.3 ml single, in left arm, for COVID-19 immunisation. The patient's medical history included unspecified allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as single dose in left arm for COVID-19 immunization. The patient's historical vaccine also included flu shot in Oct2020 and was bruised, the whole musculature from the shoulder to almost elbow, was very sore. The patient's past medication included Tetracycline take for unknown indication and experienced allergy. On 18Mar2021, 1 day after the second dose of vaccine, the patient experienced headache and nausea. On 19Mar2021, the patient experienced fever up to 101, her face, ears, neck and chest turned bright red, very hot to touch. Patient's ace, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and had allergic reactions. On an unspecified date after the second dose, the patient also experienced swollen glands, a little achy, sore and had sore throat. The patient underwent lab test and procedure which included body temperature: 101. The clinical outcome of event fever up to 101 was resolved on an unspecified date and event nausea was resolved on 20Mar2021. The clinical outcome of events headache, face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and event face, ears, neck and chest turned bright red, very hot was resolving. The clinical outcome of all other events was unknown.

Other Meds:

Current Illness:

ID: 1436813
Sex: F
Age:
State:

Vax Date: 03/23/2021
Onset Date: 03/24/2021
Rec V Date: 06/30/2021
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: Fever of 102; Headache; Body aches; extreme fatigue/ Slight fatigue on morning of day three; Extreme soreness in arm; Developed rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6208 and Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 23Mar2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Mar2020 to an unknown date. The patient was not pregnant at the time of vaccination and has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no list of any other medications received within 2 weeks of vaccination. On 24Mar2021, the patient experienced fever of 102 (as reported), headache, body aches and extreme fatigue. It was reported that the symptoms were similar when the patient had COVID in March 2020. The symptoms lasted for two days following vaccine. However, it was reported that the patient further experienced slight fatigue on morning of day three. Also, the patient experienced extreme soreness in arm, and developed rash at injection right on 24Mar2021 (reported as on day two of vaccination). No treatment was received for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient recovered from fever, headache, body aches and fatigue on 26Mar2021 and from extreme soreness in arm and rash at injection of an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1436814
Sex: F
Age:
State:

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: now I feel like I have a cold with an off and on low grade fever; now I feel like I have a cold with an off and on low grade fever; This is a spontaneous report from a contactable consumer. A female consumer of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported now she felt like she had a cold with an off and on low grade fever on 26Mar2021 with outcome of unknown. She stated that if she calls her doctor all they are going to tell her to take some Mucinex. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1436815
Sex: F
Age:
State: NY

Vax Date: 03/15/2021
Onset Date: 03/28/2021
Rec V Date: 06/30/2021
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: she can still see red marks; Rash on arms, rash on both legs, rash on belly, rash on face; This is a spontaneous report from a contactable consumer (patient herself) via Team. A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6203) via an unspecified route of administration in right arm 15Mar2021 16:30 as 1st dose, single (at the age of 52-years-old) for COVID-19 immunization. Vaccine was not administered at Facility. Patient medical history included uterine cancer. She did know when it started, they suspected it in June. Because she had anaphylactic shock they were not able to complete the biopsy. They confirmed it in 16Nov2020 with a biopsy and she had a total hysterectomy on 30Nov2020. Ongoing multiple drug allergies, she was diagnosed with some of the allergies, it would have been back in 2013. Probably they started in 2013 that they figured out she had drug allergies. She is also allergic to a lot of other medications. Rare heart attack from 2013, she had 3 stents placed. She had multiple drug allergies. She went into anaphylactic shock because of Cephalosporin in Jun2020. The concomitant medications included ongoing acetylsalicylic acid (BABY ASPIRIN) at a dose of 81 mg from 2013 , which she started taking it after having a rare heart attack, ongoing amlodipine besilate at a dose of 10 mg from May2020 for hypertension, she became allergic to ACE's and ARBs so she was started on amlodipine, Ongoing atorvastatin calcium (LIPITOR) from 2014, which she has been taking it for years for cholesterol. Patient received her first Pfizer BioNTech Covid 19 vaccine on 15Mar2021. On Sunday (28Mar2021) patient experienced a rash that only occurred when she was active. Patient received the Covid-19 Vaccine approximately 2 weeks ago on 15Mar2021. This Sunday (28Mar2021), she started having rashes. They are localized rashes. They started first on both of her legs, then they dissolved, but then they come back later. Today (30Mar2021) the rash was on her arms, belly, legs, and face. For the rash on her belly, she can still see red marks but it is not as crazy inflamed as they were. She clarifies the rash on her face started yesterday (29Mar2021) cleared up then came back again this morning (30Mar2021). Her face has improved from the angry red rash it was this morning. She clarified she went into anaphylactic shock and cardiac arrest. She woke up in the ICU with a tube down her throat because they put her in a coma, and they kept telling her she needed a bigger hospital so maybe it was not the best hospital to have a reaction at. That was the main reason she wanted to get the Covid vaccine because she did not want to end up back there. It turned out once that reaction happened they did not know why, they were not sure what happened because they were preparing her for surgery. So, she had gone to an allergist and received extensive drug allergy testing. She was told her they believed they were able to get all of the cancer with the hysterectomy and they did not think the cancer went anywhere else. For the first year she would had to be checked 3 or 4 times to make sure there is not a reoccurrence. She believed as of now she was technically considered cancer free. Because she had extensive allergies, she tried Benadryl which did not seem to have any effect maybe because it was expired. She tried Calamine lotion because the burning can be fairly intensive when the rash first started. The rash on her legs started on Sunday (28Mar2021) at about 10. The rash on her arms recently started again today (30Mar2021). She clarified the rash on her right arm started when she got up around 08. Then, the rest of the rashes on her face, stomach, and legs, started once she got going walking the dog. She could start to feel a prickly feeling (that comes with a rash). So she said by 09:00 the other rashes on her stomach, legs, and face started. When she walked in from the walk, her husband noticed she had not had those when she left but did when she came back. She thought it was something to do with the outside but now it seemed it was when she moved, it seemed activity made the rash come out. The adverse events did not result in emergency room visit, she had an appointment at physician office on Wednesday (31Mar2021). Description of product complaint included because she had extensive allergies, patient tried Benadryl (Expiration Date- Dec2019) for multiple rashes and it did not seem to have any effect. The outcome of the event rash was not resolved and that of erythema was unknown. Follow up attempts are needed. Further information has been requested.

Other Meds: BABY ASPIRIN; AMLODIPINE BESILATE; Lipitor

Current Illness: Drug allergy (Probably they started in 2013 that they figured out she had drug allergies)

ID: 1436816
Sex: F
Age:
State: NC

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 06/30/2021
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: felt anxious; hot; had a fast heart beat for a minute; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) (at the age of 61- year-old) as single dose for covid-19 immunisation. The patient had received first dose of vaccine on an unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. History included she has an allergy to Penicillin. After a few minutes of vaccine administration, the patient felt anxious, then really hot, she was fanning herself, had a fast heart beat for a minute, after a minute it went away and she didn't tell anyone. 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: 1436817
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: closing of the throat; This is a spontaneous report from a contactable consumer. A 91-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (at the age of 91-year-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient has been tested for COVID-19. On an unspecified date after second dose, the patient experienced a sensation of the closing of the throat. The patient called 911 and EMTs came to assist. She declined going to the hospital and stayed with her daughter that night for observation. The symptoms subsided by the next day. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436818
Sex: F
Age:
State: IL

Vax Date: 03/12/2021
Onset Date: 03/01/2021
Rec V Date: 06/30/2021
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: Experiencing an elevation in the heart rate/Severe, fast, pounding heart beat; Slamming between shoulder blades; Skin red; Had a little heat; Her back was sore from the heart pushing too hard; soreness inside of her body pounding so hard; She didn't know if it was an allergic reaction; Her body was exhausted; This is a spontaneous report from a contactable consumer or other non hcp (female). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 12Mar2021, 10:45 Am at a major hospital (age at vaccination was 70 years) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 12Mar2021 within an hour of receiving the vaccine patient was sent to the observation area, felt fine and went home when she left, she had a little heat later her skin turned a little red and had no rash. On 14Mar2021 morning around 5 o'clock she woke up, her heart was pounding as like her heart flipping out, slamming between into her shoulder blades and an increased heart rate, she did not know if she was having a heart attack. She stated her back was sore from the heart pushing too hard. She calmed down but her heart was still pounding and said that she could feel it beating hard, it is not pain, more like a soreness inside of her body pounding so hard and her body was exhausted. She went to the emergency room on 16Mar2021 and on 19Mar2021 and went to a cardiologist and had an EKG. When they did her EKG they told her that she was the 4th person to come in there with a rapid heartbeat after the vaccine. She was put on a beta blocker to slow the heartbeat and she was on a halter monitor and needs it to slow her heart rhythm. She went to an allergist because she did not know if it was an allergic reaction and she gave her a shot of Benadryl, which did not really do anything. She stated this was a really severe reaction with the first shot, most symptoms in people are in the second. She cancelled her second dose of vaccine. Her physician said that having her heartbeat this strong for a long time can damage the muscle. She stated she has no heart history in her life, and she was not sure what was going to happen. She had a nice peaceful calm heart rhythm before. She had continued to have to take medication for 6 weeks now. The patient wanted to know if her heart rate increase was permanent or if with time it would return to a more normal rate and that she could discontinue using the medication. when she was in the ER, which was twice last week, the doctors were trying to explain it to her by drawing on the chalkboard. The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: fast pounding heartbeat on an unspecified date. patient received treatment for she did not know if it was an allergic reaction. The outcome of the event experiencing an elevation in the heart rate/severe, fast, pounding heartbeat was not recovered and the other events was unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1436819
Sex: F
Age:
State: VA

Vax Date: 02/13/2021
Onset Date: 02/01/2021
Rec V Date: 06/30/2021
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: eyes swollen; her mouth was swollen; face swelled; allergic reaction; rash on her neck, Body rash; bad immune response; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 46-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267; Expiration Date: May2021), via an unspecified route of administration on 13Feb2021 at between 10:00am to 10:30am (age at vaccination: 46-year-old) as single dose for covid-19 immunization. The patient's medical history included non alcoholic liver disease (2017- ongoing), asthma (Unknown-ongoing), Hashimoto's disease (2002- ongoing). food allergies to a lot of raw veggies and raw fruits diagnosed in 2014 and is allergic to almonds and hazelnuts. The patient's concomitant medications were not reported. On an unspecified date, around three weeks before her first dose of bnt162b2, the patient had an unspecified allergy shot. The patient further stated that she gets four of them (allergy shots) for grass and trees, dust mites, pet dander, and the fourth is for tree pollen. On 25Jan2021, the patient took first dose of bnt162b2 (lot EL9262) on 25Jan2021 for covid-19 immunization. After receiving her second dose of BNT162B2 on 13Feb2021, around 60 hours later, on the night of 15Feb2021, the patient had allergic reaction of body rash and the patient went to HCP office. The patient stated that the rash was ongoing and worse. On 19Feb2021, the patient's face swelled. The patient further stated that the face "swells and then if she eats something it sets it off but right now her face is not swollen." On an unknown date in Feb2021, the patient's body rashes were all over and she had a lot of bad immune response to the Pfizer Vaccine and has been to urgent care on 20Feb2021, exactly 1 week after the 2nd dose of the vaccine because her face swelled up. she sought urgent care 6 days after because her mouth was swollen after eating popcorn which she was not sure if it is because of the vaccine or the popcorn. HCP prescribed Prednisone for her for 10 days and the first round of the Prednisone for her face swelling was given to her on 20Feb2021 at urgent care and it was 60mg for four days then the HCP tapered it to 40mg for three days then 20mg for three days for 10 days total. The patient was on Prednisone for those days then the body rash took four days before it went away. A few days after the Prednisone she thinks 2-3 days later the first dose of Prednisone (on an unknown date in Feb2021), the body rash started to come back. The patient restarted Prednisone for a second round on an unknown date, and called the allergist too and thought it was something she ate maybe causing her this trouble and she did not put this with the Pfizer vaccine but she read that the severe allergic reaction would occur right after the Pfizer Vaccine and her reaction was not right after the vaccine. The patient was eating normal foods and had the rash on her neck here and there , took a Benadryl one day then the rash would go away; The patient took one tablet of Benadryl which was 25mg. On 14Mar2021 morning , the patient woke up with a swollen face again with lips, eyes swollen and had a rash on the upper part of her body. The patient's HCP thought that its (the events) were due to the Pfizer vaccine. The patient thought that her body does not like the vaccine because when she eats things she is not reacting well and gets her rashes. Therapeutic measures were taken as a result of events. Outcome for the events was reported as unknown.

Other Meds:

Current Illness: Asthma (Verbatim: Asthma); Hashimoto's disease (Verbatim: Hashimoto's disease); Liver disorder

ID: 1436820
Sex: U
Age:
State: KS

Vax Date: 03/16/2021
Onset Date: 03/19/2021
Rec V Date: 06/30/2021
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: This is a spontaneous report from a contactable consumer (patient). A 58-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left arm on 16Mar2021 at 09:30 as dose 1, single (at the age of 58-years-old) for COVID-19 immunization. Medical history included salfa allergy. There were no concomitant medications. Prior to the vaccination, within four weeks patient did not receive any other vaccines and not diagnosed with COVID-19. And not received any other medications within 2 weeks of vaccination. On 19Mar2021 at 16:00, The patient experienced fever 102, headache, chills and nausea. The patient underwent lab tests and procedures which included body temperature: 102 (unknown units) on 19Mar2021. Since the vaccination, the patient had not been tested for COVID-19. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436821
Sex: F
Age:
State: CO

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 06/30/2021
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: left eye was very itchy and started with a little bit of swelling; some chest tightness; left eye was very itchy and started with a little bit of swelling; her joints, her right hand was swollen around the joints; her joints, her right hand was swollen around the joints; having kind of like a real raspy voice/raspy throat; Her joints: Caller states still ongoing, they are real stiff; allergic reaction; itching; her lips got numb, her gums were numb; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 64-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8734, Expiration date/NDC number: Unknown) via an unspecified route of administration, administered in left arm on 29Mar2021 13:45 (age at vaccination: 64-year-old) at 0.3 mL as single dose (at the age of 64-year-old) for Covid-19 immunization. Medical history included ongoing dystonia (diagnosed 20 years ago), ongoing parkinsonism (diagnosed 2 or 3 years ago), ongoing osteoarthritis and ongoing asthma. Patient had other reactions to medications in the past. Patient was not obese. Patient had no relevant family medical history. Patient parents both had passed away a really long time ago. Concomitant medical included patient was not on any new medications, had been on the same medications for a long time and patient was on ongoing treatment with botulinum toxin type A (BOTOX) every three months for dystonia, daily medication for parkinsonism and use inhaler for asthma. Patient had no vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 29Mar2021, within 5 to 10 minutes, patient had an allergic reaction, she started out itching first and her lips and her gums were starting to get numb and then her eyes started itching. Patient stated at that point they had already taken her into the other part of medical center and gave her Benadryl, around 14:00 hours, gave 50mg liquid, it was like four 12.5 mg liquid and then they made her stay longer, so she thinks she actually got out of there. Patient stated with the medical facility, they recorded it in the notes, they made her stay an hour and a half where most people were in and out in 10 minutes. Patient had left after she had been there a while, her joints, her right hand was swollen around the joints, was still ongoing, they were really stiff and had kind of like a real raspy voice. Patient stated she was still having some itchiness, eye itchiness, and some chest tightness and she was just curious as to whether or not she should consider getting the second dose. Patient stated they had made the comment that she might not want to get that, so she wanted to get some more information. Patient stated itchiness was improved a little after the Benadryl, but she doesn't like to keep taking it unless she absolutely had to because it made her so tired, so she had been taking Allegra, but she was still itchy, so she clarified it was about the same. Patient took one Allegra 30Mar2021 (yesterday), she was going to take another today, so she doesn't know. Patient stated since getting Benadryl before, she had not taken Benadryl yesterday (30Mar2021) or today (31Mar2021), it had gotten back to where it was originally. She did not know if there was something else, she should be taking, been using eye drops too. Her lips were numb and her gums but had improved a little bit, not like they were. Patient stated when first it happened, it was like she had been to the dentist when she had Novocain and she cannot feel and that what it felt like. Patient states she read the side effects and was more concerned about the breathing and the itchiness in the eyes. Patient stated that she had an inhaler, which she had been using it a little bit more than she usually does just to make sure she can breathe. Patient does not know if all may be related and stated it was about the same and persisting. Patient stated she had osteoarthritis, but it got worse after-wards and she didn't had swelling like she does, now on the one hand. Patient had no emergency room and physician office visit, she did not go because she was not getting worse and if she had gotten worse, she probably would have gone. Patient stated that real raspy voice was worsened. No relevant tests were performed. Outcome of the events allergic reaction, left eye was very itchy and started with a little bit of swelling and some chest tightness was unknown; her lips got numb, her gums were numb was recovering; whereas other events were not recovered. No follow-up attempts possible. No further information expected.

Other Meds: BOTOX

Current Illness: Asthma; Dystonia (diagnosed 20 years ago); Osteoarthritis; Parkinsonism (diagnosed 2 or 3 years ago)

ID: 1436822
Sex: M
Age:
State: TN

Vax Date: 12/17/2020
Onset Date:
Rec V Date: 06/30/2021
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: Headache; Flare ups of pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP and a contactable consumer (patient) reported that: A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 65-years-old), as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral route, daily, from 17Dec2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg (Tablet (30's), as reported), daily for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced headache and flare ups of pain. Patient states received 1st dose of COVID vaccine 03Mar2021 and has had headaches on and off and flare ups of pain for the past 2-3 weeks and it has been better the past 2-3 days no headaches or pain. MD was aware. No description of severity (i.e. If hospitalized for event). Not any medications patient was using at or around the time of the adverse event and dates of therapy. (Exclude medications used to treat event.) No any relevant tests/laboratory data including dates. Outcome of the events was recovered on an unspecified date. No follow-up attempts are needed. Information on Batch number, Lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436823
Sex: F
Age:
State: IN

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/30/2021
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: Throat burned and it felt tight; Broke out in hives; Her skin turned red; Throat burned and it felt tight; A bruise on her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 46-years old at the time of vaccination), via an unspecified route of administration in left arm on an unspecified date in Mar2021 as single dose for covid-19 immunization. Medical history included she is allergic to bees. There were no concomitant medications. Patient had no history of previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had no prior Vaccinations (within 4 weeks) and no adverse events following prior vaccination. On an unspecified date in Mar2021 (Patient was not sure whether first dose was given either 24Mar or the 25Mar), the hives and tightness in her throat happened immediately after the shot was given. Patient reported that everything resolved except for she has a bruise on her arm it is about a 50 cent piece sized bruise. She stated that began almost immediately after the dose was given. The bruise had improved a little but not much. Time the Vaccination was given about 2:00, about 2:30 she clarifies about 2:10PM in the afternoon. Clinical course of the events: the patient stated that her throat burned and it felt tight, broke out in hives, her skin turned red, a bruise on her arm. Patient received treatment for reported events with Benadryl. Reporter stated that events experienced about 20 minutes later after the dose was given. It was about 20 minutes to a half hour later. Patient visit physician office and doctor looked at her arm and he told her not to get the second shot. Patient was checked out by EMS and her breathing was okay, her vitals were all good but her throat felt tight and her doctor told not to take the second shot. It was reported that patient was only able to get one dose of the Pfizer COVID-19 vaccine because of reaction. Patient wanted to know how much immunity she has to the corona virus as her father had COPD and she wanted to know if she will be protected. Reporter seriousness for broke out in hives, skin turned red, her throat burned and felt tight was unspecified. The outcomes of reported events throat burned and it felt tight, broke out in hives, her skin turned red was recovered and outcome of event a bruise on her arm was recovering. Follow-up attempts are needed. further information requested.

Other Meds:

Current Illness:

ID: 1436824
Sex: U
Age:
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 06/30/2021
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: fever of 101.6; headache; chills; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265), dose 2 intramuscular, administered in Arm Left on 16Feb2021 at 13:00 (65-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no other vaccine within 4 weeks prior to the current vaccination. The patient had received the first dose of the bnt162b2 on 01Feb2021 and had experienced Itching rash/ hives. Concomitant medication included prednisone. On 16Feb2021 22:00, the patient experienced fever of 101.6, headache, chills and body ache. It was reported that the patient was advised to get 2nd vaccine. The patient had lowered prednisone on 26feb 2021 by dermatologist visit. Being weaned off prednisone slowly. At the date of report rash itching 99% gone, some residual marks on arms prednisone dose 2.5 mg every other until 26Mar2021 then wean off antihistamine. It was reported that the second dose of vaccine had typical adverse reaction. As bad as all of this was she felt blessed to have received and complete covid 19 vaccine and thanked Pfizer. The patient gave consent to contact her if additional information was required. The patient underwent lab tests and procedures which included blood glucose: high on 12Feb2021, blood test: high on 12Feb2021 Out of range , covid-19: negative on 08Feb2021, neutrophil count: high on 12Feb2021, white blood cell count: high on 12Feb2021. Treatment was given with Motrin for the events. Outcome of the events were recovered on 17Feb2021 at 22:00 hours. No Follow-up attempts are needed. No further information is expected

Other Meds: PREDNISONE

Current Illness:

ID: 1436825
Sex: M
Age:
State: DE

Vax Date: 03/14/2021
Onset Date: 03/24/2021
Rec V Date: 06/30/2021
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: he received his first dose of the vaccine on 14Mar2021 and tested positive for Covid a couple weeks after the first dose on 24Mar2021; This is a spontaneous report from a contactable consumer (patient, self-reporting) via Medical Information Team. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown and expiration date was not reported), via an unspecified route of administration on 14Mar2021 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He received his first dose of the vaccine on 14Mar2021 and tested positive for COVID a couple weeks after the first dose on 24Mar2021. He did not have any symptoms or anything. He was tested because he had an exposure. He asked if he can still get his second dose on Saturday. He stated he was going to go up there on Saturday and talk to them. He stated that he got an invitation for Saturday to receive his second dose but he was having an issue with the thing using the link that they sent him. He wanted assistance. He stated he cannot use computers and declined the website from the attached document. He stated he will just go up there and talk to them. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Mar2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1436826
Sex: F
Age:
State: CA

Vax Date: 03/25/2021
Onset Date: 03/31/2021
Rec V Date: 06/30/2021
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: Maybe vaccine immune response made me extra sensitive; broke out in a rash on face and chest; racy heart rate after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER26B) via an unspecified route of administration in left arm on 25Mar2021 at 11:00 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization. Medical history included Colitis ulcerative (from May 2000-ongoing). Patient was allergic to clindamycin, fennel, cinnamon, adhesive. The patient previously took clindamycin and experienced allergy to clindamycin. Concomitant medication received within 2 weeks of vaccination included adalimumab (HUMIRA). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6198) via an unspecified route of administration in arm on 04Mar2021 at 15.00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization and no reaction on previous exposure to vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 31Mar2021, 6 days later patient broke out in a rash on face and chest. Patient went through her week to see if any new products, topical ETC, food, touched anything etc but no other unusual culprit. Patient had a friend trouble shoot this with her as well. The only X factor was the vaccine. On 31Mar2021 at 13:00 hours, patient stated maybe vaccine immune response made her extra sensitive. The rash was still there. If it does not go away, She will check with in with her allergy doctor. Patient stated living in covid, She was able 2 isolate the one change -vaccine. On unspecified date in 2021, she also had racy heart rate after vaccination. Cleared up by June. Patient took lots of Benadryl plus oatmeal baths for broke out in a rash on face and chest. Since the vaccination, the patient had not been tested for COVID-19. Reporter assessed the seriousness as important medical event. The outcome of the event racing heart rate increased was recovered on an unspecified date in Jun 2021 and outcome of the other events was not recovered.

Other Meds: HUMIRA

Current Illness: Ulcerative colitis

ID: 1436827
Sex: F
Age:
State: FL

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 06/30/2021
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: experienced fever overnight; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date: Not reported), via an unspecified route of administration on 26Mar2021, as a DOSE 1 SINGLE FOR COVID-19 IMMUNIZATION. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced ?experienced fever overnight'. Caller was asking if this is a normal side effect of the vaccine and if his mother can take a medicine for the fever. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1436828
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: has an infection; This is a spontaneous report from Pfizer-sponsored program female patient reported for(herself). A Non-contactable female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported) via unspecified route of administration on unspecified date as dose number unknow, single for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. It was unknown patient was pregnant. On unspecified date, patient taken the vaccine and has an infection and was wondering if she could take a medication called macrobid. Patient was explaining her problem caller stop responding and few minutes later hanged up. The outcome of the event was unknown. No follow up needed. No further information is excepted.

Other Meds:

Current Illness:

ID: 1436829
Sex: F
Age:
State: GA

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 06/30/2021
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: tested Covid positive; fever; Chills; feel funny/felt loopy; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:15 as dose 1, single for covid-19 immunisation (52 years age at vaccination). Medical history was reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccine on the same date of Pfizer vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 26Mar2021, Patient felt funny/felt loopy, on 27Mar2021, she had fever, chills and on 30Mar2021, the patient tested covid positive. She got the first dose of the Pfizer Covid vaccine last Friday 26Mar2021 around 15:15 PM, states that she experienced side effects starting Saturday evening, 27Mar2021, states she had fever and chills, which were side effects that she read about and she took Tylenol to treat them and everything was fine, states that she noticed she went to school on Monday and talked to her principal and explained to her she got the shot and her principal said she did not look right and she decided to go home, states when she went home her husband was not feeling right so he decided to go get tested and she decided to get tested as well for Covid virus, states she tested positive for the virus on Tuesday, 30Mar2021. States it was a possibility she had it before and did not know, she had no symptoms prior to the vaccine. She stated she knew the vaccine can't give someone a Covid infection. She asked, if she need to wait 90 days before getting the second dose. The patient underwent lab tests and procedures which included Covid test: positive on 30Mar2021. Therapeutic measures Tylenol were taken as a result of fever and chills. Patient did not go to emergency room or physician's office due to adverse events. The event fever was resolved on 28Mar2021 and outcome of events covid-19 and chills was not recovered and for feeling funny and loopy the outcome was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1436830
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 06/30/2021
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: allergic reaction; couldn't swallow; shaking; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated, went on Sunday and had first Covid shot and they do not know if she had an allergic reaction or not. She went to ER and got prednisone and Benadryl. She was shaking (on an unspecified date) and got to where she could not swallow but they said there was nothing swollen. Stated, physician could not tell if she should get the second dose or not and told me to call you. Patient again stated, she should get the second dose of Pfizer vaccine or take Benadryl before getting the vaccine because she had an allergic reaction after the first dose and could not swallow (on an unspecified date). Therapeutic measures were taken as a result of allergic reaction, couldn't swallow, shaking. The outcome of events was unknown. Information on lot number/batch number was requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm