VAERS 2021 Database www.vaers.hhs.gov

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

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

Incidents per State

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

ID: 1401761
Sex: F
Age:
State: CA

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 06/16/2021
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: her throat started to feel like it's really tight and closing but it didn't actually close/Throat tightness; Woozy; Fatigue; she feels like it's getting worse/this morning it is progressively getting tighter; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9261), via an unspecified route of administration in right arm on 04Feb2021 at 09:17 am as a single dose for COVID-19 immunization. The patient's medical history included cancer was diagnosed in Jun2019. The Enlarged Goiter Onset was about 10 years ago, her mom actually had thyroid cancer and so because of that she had her throat checked, they told her in the past that it was large and to not worry, but then she also got body whole scan in Dec2020, the oncologist said she has an enlarged goiter and that she has nothing to worry about. Concomitant medication included anastrozole (ARIMIDEX). She has had no positive covid or antibody test prior to the first dose. She has had no other vaccinations in the 4 weeks prior. She has had no issues with vaccines in the past, no allergies nothing. On the night of 04Feb2021, the patient stated that at night her throat felt like it was really tight and closing but it didn't actually close. She was still experiencing it at the moment and felt like it was getting worse. She concerned and stated that, she did get the first dose yesterday and she felt woozy, she felt fatigue. She noticed as she was going to bed, her throat was tight, all night long she was adjusting her pillow, it just feels tight, and this morning it was progressively getting tighter. She does want to add a bit of background that she thinks could be related, that she was a cancer survivor, but it's not even a year out that she has been cancer free, she still takes Arimidex. They also did a scan and said that she had an enlarged goiter, so she has had the throat problems for the last month or so. Caller states that she did not know if this was associated. The patient stated that she felt woozy right after receiving the vaccine, within first 15 minutes. The Fatigue was also on the same day around 4PM or 3:30PM. It was like a suppression feeling. She was talking to herself calm down, she was just feeling overwhelmed, she had to tell herself to relax, and drank water. The patient also experienced Fatigue which ended after she took a nap. Caller clarified that she thinks that she has experience throat tightening before, when she was either sick or had a sore throat, but at the moment when she was experiencing throat tightening recently, she would just try to say herself to calm down. The patient stated that the throat tightening started at night, when she was about to relax before bed on 04Feb2021. The patient stated that as she was going to bed, her throat was tight, all night long and she was adjusting her pillow, it just felt tight, and in the morning, it was progressively getting tighter. She was drinking hot and warm tea but even that's making it worse. The caller stated that she actually has 3 doctors whom she frequently visits. and she was still monitoring her because the cancer she had was aggressive. There was also her Primary Care doctor. Wants to know what she needs to do about it and if this is because of the vaccine. Caller wanted to know about risks of the vaccine what to do with the side effects and who should not get the vaccine. Therapeutic measures were taken as a result of her throat started to feel like it's really tight and closing but it didn't actually close/throat tightness, woozy, and fatigue. The outcome of the events was resolved for woozy, and fatigue on 04Feb2021, and not resolved for the evenst throat tightening and feels like it's getting worse/this morning it is progressively getting tighter. Follow-up attempts completed. No further information expected.

Other Meds: ARIMIDEX

Current Illness:

ID: 1401762
Sex: F
Age:
State: WA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 06/16/2021
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: She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; She stated that on Saturday (30Jan) and Sunday (31Jan) she ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021).; she is lactating, and is currently weaning her 19 month old son; she is lactating, and is currently weaning her 19 month old son; This is a spontaneous report from a Non contactable Nurse. This Nurse reported events for mother and baby. This case is for the mother. A 34-year-old female patient (mother) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Jan2021, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. At the time of vaccination, the patient was lactating and was currently weening her 19-month-old son. The reporter stated that on Saturday (30Jan2021) and Sunday (31Jan2021) the patient ran a fever of 101.4 F and felt un-well enough to be bedridden for two days (through Sunday, 31Jan2021). Reporter does not know exact date of birth, but reporter believe she was 34 years old. Outcome of the events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122449 Child and Maternal case

Other Meds:

Current Illness:

ID: 1401763
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: arm soreness; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. On an unknown date, patient experienced arm soreness following both vaccine injections. 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: 1401764
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: Sore arm; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer or other non HCP reported, A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expiration Date: unknown) via unspecified route of administration on an unspecified date as first dose single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after first dose, the patient experienced Sore arm. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401765
Sex: M
Age:
State: GA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 06/16/2021
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: Heart palpitation; Tachycardia; Diaphoresis; Shakiness; This is a spontaneous report from a contactable Other HCP. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3302) intramuscularly, administered in Arm Left on 02Feb2021 at 09:25 AM (at an age of 56-years, 7 months during vaccination) as single dose for COVID-19 immunisation. The patient's medical history included enlarged prostate, urinary frequency with no infection, hypertension. The patient previously took Doxycycline. The patient was allergic to medication, food, or other products including Doxycycline. The patient's concomitant medications included amlodipine, tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]). The patient had not experienced adverse event following any previous vaccine. On 02Feb2021 at 09:53 AM, the patient experienced diaphoresis, shakiness, heart palpitation and tachycardia. Diaphoresis and shakiness ended by 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. On an unknown date, the patient underwent lab test and procedure which included: Blood glucose: 126 mg/dl. The patient was advised for relaxation. On the 02Feb2021, the outcome of the events was recovered for Diaphoresis and shakiness at 10:18 AM and Heart palpitation and tachycardia ended around 10:25 AM. Follow-up attempts are completed. No further information is expected.

Other Meds: AMLODIPINE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]

Current Illness:

ID: 1401766
Sex: F
Age:
State: MD

Vax Date: 01/22/2021
Onset Date: 01/24/2021
Rec V Date: 06/16/2021
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: Second dose delayed; High fever; chills; body and joint aches; body and joint aches; severe headache; difficulty sleeping; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; lose of taste and smell (1st dose only) for almost 2 weeks post first dose, 48 hours for second dose; This is a spontaneous report from a contactable other HCP (patient). A 49-year-old non-pregnant female patient received second dose of BIONTECH (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her right arm on 22Jan2021 04:00 PM (Lot number: EL1283) as single dose for Covid-19 immunization. Age at vaccination: 49-year-old. Facility-type-vaccine: Workplace clinic. Covid was not tested prior vaccination. The patient's medical history included asthma and back injury. Known allergies included sodium benzoate, ASA, NSAIDS, mushrooms and seafood. Concomitant medications included Betacarotene/bioflavonoids NOS/biotin/calcium ascorbate/calcium pantothenate/calcium phosphate/choline bitartrate/chromic chloride/colecalciferol/copper sulfate/cyanocobalamin/folic acid/hesperidin/inositol/iron amino acid chelate/lycopene/lysine hydrochloride/magnesium oxide/manganese sulfate, molybdenum trioxide/nicotinamide/phytomenadione/potassium iodide/potassium sulfate/pyridoxine hydrochloride/retinol acetate/riboflavin/selenomethionine/silicon dioxide/colloidal/sodium borate decahydrate/thiamine mononitrate/tocopheryl acid succinate/ubidecarenone/zinc oxide (MULTIVITAMIN), colecalciferol (D3), iron, magnesium citrate and linum usitatissimum seed oil (FLAX SEED OIL) (other medications in two weeks). The patient previously took first dose of BIONTECH administered to her right arm on 22Dec2020 03:15 PM (Lot number: E49899) as single dose for Covid-19 immunization and experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, diarrhea, and loss of taste and smell (for almost 2 weeks post first dose). The patient experienced high fever, chills, body and joint aches, severe headache, difficulty sleeping, and loss of taste and smell (48 hours for second dose). Second dose delayed, RT-PCR Covid-19 and Influenza, SARS-COV-2 aB test on on 5 Jan, 13 all negative. AE resulted in doctor or other healthcare professional office/clinic visit. Covid-test-post-vaccination: Covid test type: nasal swab, test name: RT-PCR PAN-SARS CORONAVIRUS, SARS-COV-2 (COVID-19), test date: 05Jan2021, result: Negative. The patient did not receive any treatment in response to the events. Outcome of the event second dose delayed was unknown, whereas other events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: MULTIVITAMIN & MINERAL; D3; IRON; MAGNESIUM CITRATE; FLAX SEED OIL

Current Illness:

ID: 1401767
Sex: F
Age:
State: GA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 06/16/2021
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: Arm sore; wrist pain; hand cramps; runny nose; rash on stomach; This is a spontaneous report from a contactable other HCP (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number EL3249), via an intramuscular route in the arm right on 26Jan2021 (at the age of 37-year-old) as 2nd dose, single dose for covid-19 immunization in Public Health Clinic. Medical history included allergy to sulfa drugs, supraventricular tachycardia and high blood pressure. Concomitant medications in two weeks included metoprolol succinate, losartan, atomoxetine hydrochloride (STRATTERA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulphate (ADDERALL) and fexofenadine hydrochloride (ALLEGRA). Historical vaccine included first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Lot number- EK4176), via an intramuscular route in the arm left on 06Jan2021 (at the age of 37-year-old) as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 27Jan2021, patient experienced arm sore, wrist pain, hand cramps, runny nose and rash on stomach. Patient did not receive any treatment for the events. On 10Jan2021 patient underwent nasal swab test with result as negative (POC COVID-19). The clinical outcome of the events was recovered at the time of this report. Follow-up attempts are completed. No further information is expected.

Other Meds: METOPROLOL SUCCINATE; LOSARTAN; STRATTERA; ADDERALL; ALLEGRA

Current Illness:

ID: 1401768
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 02/07/2021
Rec V Date: 06/16/2021
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: UTI; tested positive for covid; This is a spontaneous report from a contactable consumer. This consumer (granddaughter) reported for a female patient (grandmother) that a 92-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: unspecified) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was taken to emergency room yesterday. She was acting funny because she had urinary tract infection (UTI) on an unspecified date. She had no symptoms but tested positive for COVID while in emergency room on 07Feb2021. The caller was asking if grandmother should be tested again for covid. The patient underwent lab test which included covid test (Sars cov-2 test) and the results were positive on 07Feb2021. The outcome of the events was unknown. Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401769
Sex: F
Age:
State: TX

Vax Date: 02/05/2021
Onset Date: 02/07/2021
Rec V Date: 06/16/2021
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: A huge fever blister appeared on day 2 after vaccine. I haven't had one in; This is a spontaneous report from a contactable consumer or other non hcp. A 51-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 05Feb2021 12:30 PM as 1st dose single for an unspecified indication. Medical history included hypertension, obesity, drug hypersensitivity and known allergies: Penicillin. Concomitant medications included Zoloft (sertraline hydrochloride), taken for an unspecified indication, vitamin C taken for an unspecified indication, vitamin D (colecalciferol) taken for an unspecified indication. The patient not had covid prior vaccination and post vaccination. On 07Feb2021 07:00AM, The patient experienced ?A huge fever blister appeared on day 2 after vaccine. Patient stated she haven't had one in years and this one was bigger than ever. Treatment was not reported. The outcome of the event was not recovered. Follow-up (13May2021): Follow-up attempts completed. No further information expected

Other Meds: ZOLOFT; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1401770
Sex: F
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: tiredness; headache; muscle pain; nausea; ear infection; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as for the last weeks), patient experienced tiredness, headache, muscle pain and nausea and had to go on an antibiotic for an ear infection. Patient had Covid test, and it came back negative. Patient was scheduled for 2nd dose on Monday. The outcome of events was unknown. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1401771
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 06/16/2021
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: Swollen armpit lymph nodes; This is a spontaneous report from a non-contactable other HCP (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 28Jan2021 at 15:15 in left arm as a single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received in two weeks included multi vitamin and vitamin c (VITAMIN C [ASCORBIC ACID]) both taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug allergy. The patient experienced swollen armpit lymph nodes on 30Jan2021 at 10:00. Patient did not receive any treatment. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1401772
Sex: M
Age:
State: MA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 06/16/2021
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: Nausea; cold sweat; This is a spontaneous report from a contactable consumer (patient). This 25-year-old male consumer reported that he received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247) via intramuscular route of administration in left arm on 01Feb2021 at 14:35 (at the age of 25-year-old), as unknown, single dose for COVID-19 immunization. Medical history included gallbladder removed about 5 years ago and covid around Dec2020 to an unknown date. Family Medical History Relevant to AE includes his mom was allergic to penicillin. There were no concomitant medications. It was mentioned that the patient did not receive any other products and had no investigation assessment. There was none additional vaccines administered on same date of the pfizer suspect. Adverse event prior vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. On 01Feb2021, 10 minutes after receiving the injection patient reported that he had nausea for about 40 minutes and said that he broke into a cold sweat when he got nauseated and when that cold sweat subsided, he started to feel better. He stated that the cold sweat only lasted about 1-2 minutes. The patient mentioned that he rarely gets sick. The patient did not require emergency room or physician office visit. He said that the last time he went to the doctor was when he had his gallbladder removed about 5 years ago. There were none relevant tests. The events recovered on the same day (01Feb2021). Follow-up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1401773
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: our arm was a bit sore; This is a spontaneous report from a contactable female consumer reported for herself. A 70-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient stated there arm was a bit sore. The outcome of the event was unknown. Information about lot/batch number has been requested. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1401774
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunizations. The patient past medical history and concomitant medication was not reported. The patients previous vaccine was a flu shot 4-5 months before for immunization and he took some herbs. The patient also took 1st dose of BNT162B2 and experienced adverse events. He was doing his own investigation as well and need to know if there's a virus in the vaccine after the 2nd dose he experienced flu like symptoms on an unspecified date. first dose of the Pfizer vaccine and right after experienced lower right side back pain and joint pain, but it subsided. The event outcome is unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401775
Sex: F
Age:
State: MA

Vax Date: 01/27/2021
Onset Date: 01/01/2021
Rec V Date: 06/16/2021
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: Fatigue 24-48 hours after injection; Pain at the injection site up to 3 days; This is a spontaneous report received from a contactable consumer (patient). A 34-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 at 13:00(at the age of 34 years old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient does not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient experienced fatigue 24-48 hours after injection, pain at the injection site up to 3 days on an unspecified date on Jan2021. The patient did not receive any treatment for events. Outcome of all the events were recovered. Information about lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1401776
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 06/16/2021
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: Experienced pain in my left arm around the site of injection; Not sleeping well; Pain in the left clavicle and shoulder; My arm still hurts a little bit; This is a spontaneous report received from a non-contactable consumer. A 50-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN5318), via an unspecified route of administration in left arm on 27Jan2021 as single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included metoprolol, vitamin D3, multivitamins. Patient had no known allergies. On 27Jan2021, the patient experienced pain in my left arm around the site of injection. First night I was not sleeping well because of the pain. Next day there was also pain in the left clavicle and shoulder. My arm still hurts a little bit but now I was able to sleep on the left side again. No treatment was received for the events. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The outcome of the events was reported as recovered on unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds: METOPROLOL; VITAMIN D3

Current Illness:

ID: 1401777
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The caller stated her arm always gets sore, even with the first dose of the vaccine and with flu shots.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took flu shots. On an unspecified date, the patient experienced that her arm always got sore, even with the first dose of the vaccine and with flu shots. The patient stated she received the second dose of the vaccine on Saturday and had absolutely no side effects. The patient wanted to know if it was normal to not have any side effects at all. The outcome of event was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401778
Sex: F
Age:
State: AZ

Vax Date: 12/26/2020
Onset Date:
Rec V Date: 06/16/2021
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: Mild arm soreness; This is a spontaneous report from a contactable pharmacist and a contactable physician (patient). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EH9899) via intramuscularly on 26Dec2020 at 10:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no significant preexisting medical conditions prior to the vaccine. Concomitant medications were not reported. It was unknown, whether the patient was diagnosed with COVID-19 prior to vaccination and it was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, after the first dose the patient experienced mild arm soreness. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401779
Sex: F
Age:
State: CA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 06/16/2021
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: Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. 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. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021. Follow-up attempts are completed. No further information is expected.

Other Meds: PRAVASTATIN; HYDRALAZINE; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1401780
Sex: F
Age:
State: PA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 06/16/2021
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: Severe stomach pain with burning/residual stomach muscle cramps; Severe stomach pain with burning; severe headache; gas and bloating; gas and bloating; feverish; vomited once; fatigue and malaise and residual stomach muscle cramps; fatigue and malaise and residual stomach muscle cramps; This is a spontaneous report from a contactable other healthcare professional, the patient. A 54-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/batch number: EL9261) via an unspecified route of administration in the left arm, as 1ST DOSE, SINGLE DOSE on 29Jan2021 at 17:15 (at the age of 54-years) for COVID-19 immunization. Medical history included rheumatoid arthritis and crohn's disease. Concomitant medications included methotrexate sodium (METHOTREXATE INJECTION BP), mesalazine (ASACOL), fluoxetine hydrochloride (PROZAC), montelukast sodium (SINGULAIR) and XYZ (taken within 2 weeks of vaccination). The patient previously took aspirin (E.C.), celecoxib and salicylate sodium and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19 On 29Jan2021, the patient experienced severe stomach pain with burning, severe headache, gas and bloating, feverish, vomited once, fatigue, malaise and residual stomach muscle cramps. The patient did not receive any treatment for the adverse events. The clinical outcome for the events was recovered with sequel and with lasting effects. Follow-up attempts are completed. No further information is expected.

Other Meds: METHOTREXATE INJECTION BP; ASACOL; PROZAC; SINGULAIR

Current Illness:

ID: 1401781
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 02/09/2021
Rec V Date: 06/16/2021
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: cold sore 20 days after #1 covax; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown expiry date: unknown) via an unspecified route of administration on an unspecified date as first dose single dose for COVID-19 vaccination. The patient medical history and concomitant medication were not reported. After administration of the first dose the patient had experienced cold sore 20 days after 1 covax on 09Feb2021. The reporter pharmacist if there would be a drug interaction with a patient getting second covax today and on acyclovir. The patient was on it for cold sore developed 09Feb last dose will be on 13Feb and he is to get the second dose today, first covax was 21 days ago. The outcome of event was unknown. Information on the Lot/Batch number has been requested Follow-up (12May2021): Follow-up attempts completed. No further information expected

Other Meds:

Current Illness:

ID: 1401782
Sex: F
Age:
State: NY

Vax Date: 01/01/2021
Onset Date: 01/20/2021
Rec V Date: 06/16/2021
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: a breast ultrasound revealed swollen lymph nodes on left side under armpit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EK9231), via an unspecified route of administration in arm left on 01Jan2021 at 11:00 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. Age at vaccination was 56 years. The patient's concomitant medications included raloxifene hydrochloride (RALOXIFENE [RALOXIFENE HYDROCHLORIDE]), vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]), krill oil, levocetirizine dihydrochloride (XYZAL) and Multivit. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 20Jan2021 at 11:00 AM, the patient experienced a breast ultrasound revealed swollen lymph nodes on left side under armpit. Treatment was not received for the event. On 20Jan2021, the patient underwent lab tests and procedures which included breast ultrasound, resulted as swollen lymph nodes on left side under armpit. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in arm left on 01Feb2021 as a 2nd dose, single dose for COVID-19 immunization. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.

Other Meds: RALOXIFENE [RALOXIFENE HYDROCHLORIDE]; B COMPLEX [VITAMIN B COMPLEX]; KRILL OIL; XYZAL

Current Illness:

ID: 1401783
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 06/16/2021
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: today feeling headaches; fatigue; dizziness; 2nd lethargic; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; sleepy on the first day; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 29Jan2021 (at the age of 80-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included tobacco(Smoker). Concomitant medications were not reported. The patient previously took buspar. Other medication in two weeks included Buspar. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 11Jan2021 13:00. No other vaccine was received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 29Jan2021 the patient experienced sleepy on the first day, 2nd lethargic, 3rd ok and 4th day, today feeling headaches fatigue and dizziness. No treatment received for AE. The outcome of the events sleepy, lethargic, headaches, fatigue, dizziness was reported as not recovered and unknown for other events. Information on batch/lot number was requested. Follow-up (26May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected

Other Meds:

Current Illness:

ID: 1401784
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 06/16/2021
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: Swollen lymph nodes in armpit of arm where injection was put. Tender to touch.; Swollen lymph nodes in armpit of arm where injection was put. Tender to touch.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 26-years-old non pregnant female patient received bnt162b2 (BNT162B2? (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on an unspecified date (Lot Number: EL9264, Expiration date: Unknown) as 1st dose, single dose for COVID-19 immunisation. There were no known allergies. Medical history included COVID-19 from Nov2020 to an unknown date, bipolar disorder from an unknown date. Concomitant medication included duloxetine (DULOXETINE, 60mg daily) taken for an unspecified indication, start and stop date were not reported, lamotrigine (LAMOTRIGINE, 100mg daily) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. COVID was not tested post vaccination. On 01Feb2021 07:00, the patient experienced swollen lymph nodes in armpit of arm where injection was put, tender to touch. Therapeutic measures were not taken as result of events. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: DULOXETINE; LAMOTRIGINE

Current Illness:

ID: 1401785
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: sore arm; This is a spontaneous report from a non-contactable consumer Patient's wife). A 64-year-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on right arm on an unspecified date as an unknown single dose for COVID-19 immunisation. The patient's medical history and Concomitant medications was not reported. It was reported that, patient had it also and he only had a sore arm, not bad and he was shoveling some snow today (date unspecified). Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.

Other Meds:

Current Illness:

ID: 1401786
Sex: F
Age:
State: KS

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 06/16/2021
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: sharp pain in left jaw when touched; This is a spontaneous report from a contactable consumer(patient). A 53-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: en5318) via an unspecified route of administration in left arm on 01Feb2021 at 09:30 (at the age of 53-years-old) as 1st dose, single dose for covid-19 immunisation. Facility type vaccine was clinic. Medical history included thyroid, high blood pressure and arthritis. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. No known allergies reported. The patient's concomitant medications were not reported. Other medications in two weeks reported. The patient did not receive any vaccines within four weeks prior to the vaccination. On 02Feb2021 at 08:00, the patient experienced, sharp pain in left jaw when touched. The patient did not receive any treatment for the event. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401787
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: her symptoms worsened; This is a spontaneous report from a contactable physician from a 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. Medical history included strong traumatic disorder (PTSD) (is take SSR medications). The patient's concomitant medications included SSR medications for PTSD. On an unspecified date, the patient's symptoms worsened. The physician wanted to know if that side effect was associated with the vaccine and the potential side effects of the second dose. The reporting physician assessed the event as non-serious. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401788
Sex: M
Age:
State: CA

Vax Date: 02/09/2021
Onset Date: 02/12/2021
Rec V Date: 06/16/2021
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: cold sore; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (Solution for injection, lot number: unknown) via an unspecified route of administration in left arm on 09Feb2021 at 15:30 as 2nd dose, single dose for covid-19 immunisation. Medical history included PCN (penicillin) allergy and covid-19 from an unknown date and unknown if ongoing. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and sildenafil citrate (VIAGRA). No other vaccine was received in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunisation. Covid tested post vaccination was reported as no. Patient reported that after his first vaccine, two days later he noticed that he had a cold sore. Patient was not concerned and on 12Feb2021 at 05:00 am, after the second vaccine experienced his face broke out all over with over five separate sites containing cold sores. Treatment received for the adverse events with topical ointment to put on the cold sores. The outcome of the event was not resolved. Information on the lot/ batch number has been requested. Follow-up (12May2021): Follow-up attempts completed. No further information expected.

Other Meds: CYMBALTA; VIAGRA [SILDENAFIL CITRATE]

Current Illness:

ID: 1401789
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 06/16/2021
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: Sweating profusely, like in a bath; Not able to sleep; sick as a dog; Then spread through whole arm and hole hand; 6-7 hours later, pain getting worse and worse; Then to other arm, neck and head; Then to other arm, neck and head/ Headache; Dizziness; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 29Jan2021 at 08:30Am (Batch/Lot number was not reported) as 2nd dose, single dose COVID-19 immunization. The patient medical history included unspecified cardiac history. The patient concomitant medications were not reported. Historical vaccine included 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation and experienced some pain in the arm. The patient reported she and her husband received the vaccine. For her husband everything went fine. The patient stated that, after the second vaccine last Friday morning at 8:30am, 29Jan2021, had to stay after her vaccine for 30 minutes due to previous unspecified cardiac history. Her husband was fine but stated she was disaster and sick as a dog. Did not start immediately, initially just pain in arm again. Then 6-7 hours later, pain getting worse and worse. Then spread through whole arm and hole hand. Then to other arm, neck, and head. Used Tylenol for treatment. Stated, every cell in her body was affected: toes, fingers, joints, bones, all over body. The severe reactions were approximately 8-10 hours after vaccine but caller not sure. Stated it was horrendous, never experienced such pain, could not find herself in bed. The pain was to point could not lift self out of bed and could not eat. When pain subsided, headaches persisted, and dizziness accompanied it. Up to 30 hours, Saturday night, was sweating profusely, like in a bath. The headache was there after the 30 hours but not intense enough to require pain medication. Was not able to sleep Saturday night, took melatonin. The dizziness was very scary because it came in slashes, came, and left multiple times. Sunday improved but not very function able Called her physician yesterday. Better yesterday but not herself. Today is the first day she is feeling better. Caller stated some of the time periods may not be accurate as she changed a couple times. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1401790
Sex: F
Age:
State:

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 06/16/2021
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: Cough; Sore throat; came up positive for Covid; This is a spontaneous report from a contactable consumer (patient). This female consumer of unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported, expiry date: not provided), dose 1 via an unspecified route of administration on 23Jan2021 as 1st dose, single for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got a cough and sore throat. She got tested and came up positive for Covid-19 ten days after the shot. She might have had it before the shot or gotten it in-between, but she did not known. The outcome of events was unknown. The patient was supposed to get second dose of vaccine on 13Feb2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401791
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: Get a little discomfort in her hand; This is a spontaneous report from a contactable physician (Patient herself). A 82-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, Solution for injection in pre-filled syringe) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN DOSE, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced get a little discomfort in her hand on an unspecified date. She mentioned she initially felt some discomfort in her hand which is usual with any vaccine. Stated she was tall, but is now 5ft 3 inches. Weight was between 125-127. Events after prior vaccinations she stated she would get a little discomfort in her hand, but nothing significant. Nothing special. She did not have a fever or anything. The outcome of the event was unknown. Pfizer is a marketing authorization holder of [(pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [(pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)] has submitted the same report to the regulatory authorities. No follow up attempts are needed, information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1401792
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: typical soreness of injection site in my Left Arm; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date, as 1st dose, single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included evolocumab (REPATHA SURECLICK) and lorazepam (LORAZEPAM), taken for unspecified indications. The patient was hypertensive to these medications. On an unspecified date, after her first dose of vaccine, the patient experienced typical soreness of injection site in her left arm. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: REPATHA SURECLICK; Lorazepam

Current Illness:

ID: 1401793
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: Wife had pain in her arm after receiving the vaccine 75 years old; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN,SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced wife had pain in her arm after receiving the vaccine 75 years old on an unspecified date. The outcome of the events was reported as unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401794
Sex: F
Age:
State: AZ

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 06/16/2021
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: I did have COVID before in June and symptoms are very similar to that I am experiencing right now; Fever; Chills; Body aches, muscle aches pretty much everything, joint ache; Body aches, muscle aches pretty much everything, joint ache; Headache; Body aches, muscle aches pretty much everything, joint ache; This is a spontaneous report received from a contactable consumer (patient- caregiver). A 38-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9263, Expiration date: Unknown), via an unspecified route yesterday on 20Feb2021 at 12:45, as a single dose for covid-19 immunization. Medical history included covid in Jun2020 with symptoms that were very similar to what patient was experiencing right now and got 2 moles removed. Concomitant medications included birth control, fish oil, vitamin D, multivitamin, green tea and pota. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. On 21Feb2021 today morning since 14:00, patient experienced fever, headaches, body aches, muscle aches pretty much everything, joint ache, chills, and wanted to know this is normal, how long it will last and what she should do with these side effects. Treatment received as a result of events included Tylenol. The clinical outcome of the events was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1401795
Sex: M
Age:
State: MA

Vax Date: 02/23/2021
Onset Date: 02/24/2021
Rec V Date: 06/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report from a contactable consumer (reported for himself). A 58-years-old male patient received second dose of BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 23Feb2021 at 08:15 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 01Feb2021 at 08:10 (at the age of 58-years-old) as single dose for COVID-19 immunisation. On 24Feb2021, at 05:00, the patient experienced she woke up in the morning feeling muscle aches, weakness and temperature 99.5. The patient underwent lab tests and procedures which included pyrexia: 99.5 on 24Feb2021. No treatment was given for the events. The outcome of the events was resolving. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1401796
Sex: F
Age:
State: NJ

Vax Date: 02/08/2021
Onset Date: 02/10/2021
Rec V Date: 06/16/2021
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: Facial numbness especially over the lips, spreading from chin to eyes sockets; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on left arm on 08Feb2021 at 19:00 (at the age of 57-years-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergies to percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol] and experienced drug allergy (hypersensitivity). Concomitant medications in two weeks included loratadine (LORATADINE), thyroid (ARMOUR THYROID) both were taken for an unspecified indication and start and stop date were not reported. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on unspecified date at single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021 at 06:00 The patient experienced facial numbness especially over the lips, spreading from chin to eyes sockets. The patient did not received treatment for the events. The outcome of the event was recovered on unspecified date. Information on the lot/batch number has been requested.

Other Meds: LORATADINE; ARMOUR THYROID

Current Illness:

ID: 1401797
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 06/16/2021
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: itching all over; This is a spontaneous report from Team. A contactable consumer (patient) reported that a 68-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 13Jan2021 as single dose in left arm for the COVID-19 vaccination. Medical history was ongoing back pain. Concomitant medication reported was oxycodone as 5 mg, as needed for back pain. Consumer WAs calling about the Pfizer COVID-19 vaccine and said she took her first shot on 13Jan2021 and she also takes Oxycodone when she has a backache, which she hasn't taken for a while, and she took some and now she had itching all over. She said can Oxycodone have some kind of affect if she has had the vaccine. Caller said she know it expires Dec2021 and was 5mg, it was a liquid one, it was red medicine that comes in a bottle. Caller said she doesn't have her vaccine card with her to provide information from it. She said that she was given her first dose injected in her left arm. Caller said they have not had any other recent vaccinations or started any new medications. Caller stated she took Oxycodone liquid 5 mg and wanted to know if there will be an interaction with the Pfizer covid 19 vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Other Meds: OXYCODONE

Current Illness: Back pain

ID: 1401798
Sex: F
Age:
State: NJ

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 06/16/2021
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: Fever; Extreme chills; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in arm left on 19Feb2021 at 16:00 (at the age of 73-years-old) as single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient did not had known allergies. Concomitant medications included verapamil, olmesartan medoxomil and dexlansoprazole (DEXILANT). Patient did not had COVID prior to vaccination and has not been tested for COVID post vaccination. On 19Feb2021 at 00:00, the patient experienced fever and extreme chills. The patient did not receive treatment for the events. The outcome of the events was resolved. Information on the lot/batch number has been requested.

Other Meds: VERAPAMIL; OLMESARTAN MEDOXOMIL; DEXILANT

Current Illness:

ID: 1401799
Sex: M
Age:
State: OK

Vax Date: 02/19/2021
Onset Date: 02/22/2021
Rec V Date: 06/16/2021
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: uncomfortable swallowing; swollen lymph nodes, especially on the left side; I've had some sinus issues, sinusitis; feels like if I had TMJ; Jaw pain/right jaw is the one hurting; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 72-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included , gastrooesophageal reflux disease from an unknown date and unknown if ongoing He takes Protonix daily capsule for this, cluster headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced jaw pain/right jaw is the one hurting on 22Feb2021 with outcome of unknown, uncomfortable swallowing, swollen lymph nodes, especially on the left side , He had some sinus issues, feels like if he had temporomandibular joint syndrome on an unspecified date with outcome of unknown. Therapeutic measures were taken with Tylenol and Ibuprofen as a result of jaw pain/right jaw is the one hurting (pain in jaw), uncomfortable swallowing (dysphagia), swollen lymph nodes, especially on the left side (lymphadenopathy) No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1401800
Sex: M
Age:
State: FL

Vax Date: 02/08/2021
Onset Date: 02/11/2021
Rec V Date: 06/16/2021
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: he could hardly walk. He would have a difficult time walking and standing still; Tested Positive for COVID; Tiredness/Fatigue; Achiness; slept a lot on Thursday; not feeling well; sinus sneezing issues; Sneezing; This is a spontaneous report from a contactable Nurse. This nurse reported that a 69-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL9262 and expiration date were not reported), dose 1 via an unspecified route of administration, administered in left deltoid on 08Feb2021 at 15:15 as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing Blood pressure, which is under control; back pain; nerve issue; stated he sneezes a lot with seasonal allergies; patient fell and broke his wrist (over a month ago the patient fell and broke his wrist); lack of sleep at night (A nap was common for him due to lack of sleep at night due to the facture); her husband had a sinus infection (with a negative COVID-19 test back in November); Prostatitis and blood disorder. Concomitant medication(s) included Metoprolol 25 mg, daily for blood pressure, Irbesartan 150 mg, once a day for high blood pressure, Gabapentin 300 mg twice a day morning and evening for Back pain/nerve issue, Vitamin D 2,000 units daily, Tamsulosin 0.4 mg once daily at night for Prostate, acetylsalicylic acid (BABY ASPIRIN) 81 mg once a day for circulation, magnesium 400 mg daily, Calcium 600 mg, Vitamin C 1000 mg daily and sometimes twice daily for sinus infection which were all ongoing. On 11Feb2021, the patient experienced a sinus sneezing issues, not related to the vaccine. He sneezes a lot with seasonal allergies also had negative COVID-19 test back in November. However, they thought it was due to the indoor activities occurring at that time then Thursday on 18Feb2021, started to have a sense of being tired, achiness and fatigue on 11Feb2021. He was could hardly walk. He would have a difficult time walking and standing still, achy, tired, and slept a lot on Thursday. His whole attitude/behavior was one that would reflect someone not feeling well. On Friday, 19Feb2021, he was not so bad. Feeling a little better. On Saturday 20Feb2021, went to urgent care and got a Rapid COVID Test done and his came back positive for COVID and requested a PCR test be done, but where they are it's only done in 3-4 different locations. A PCR test has been done, but they are currently waiting on the results for this report. On 21Feb2021 went to another testing facility for the PCR and it also confirmed positive for him. He is feeling better. He is not achy. He is resting and isolating himself. The outcome of events for sneezing was recovered on 21Feb2021; for achiness was recovered on 20Feb2021; for tested Positive for COVID, slept a lot on Thursday, sinus sneezing issues was unknown; for Tiredness/Fatigue, not feeling well, he could hardly walk/He would have a difficult time walking and standing still is recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218283 same reporter/drug, similar event, different patient

Other Meds: METOPROLOL; IRBESARTAN; GABAPENTIN; VITAMIN D NOS; TAMSULOSIN; BABY ASPIRIN; MAGNESIUM; CALCIUM; VITAMIN C [ASCORBIC ACID]

Current Illness: Blood pressure abnormal (Blood pressure high /Under control)

ID: 1401801
Sex: F
Age:
State: NY

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 06/16/2021
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: Swollen throat; increased heart rate; nausea; flushing; This is a spontaneous report from a contactable consumer (patient, reported for herself). A 31-years-old female non-pregnant 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, in arm left on 25Feb2021 at 14:15 (at the age of 31-years-old) as 1st dose, single dose for Covid-19 immunisation. The patient medical history included osteoma from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, allergy to animal from an unknown date and unknown if ongoing and seasonal allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took penicillin nos (PENICILLIN) and experienced allergy and she was allergic to animal (cat, pollen). The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines on the same day of vaccine vaccination. On 25Feb2021 at 14:15, the patient had experienced swollen throat, increased heart rate, nausea and flushing. The patient was treated with Benadryl and Deltasone. The reporter stated the events result in emergency room/department or urgent care. The outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1401802
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: I got nauseated and was not feeling good; little bit fever/fever 102.6; was not feeling good; I feel like I got COVID again; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6202, expiration date unknown) via an unspecified route of administration administered on an unspecified date as 1st dose, single for covid-19 immunization. Medical history included covid-19. The concomitant medications were not reported. On an unknown date, patient stated that, I had my second vaccine yesterday the Pfizer and on the first one I got nauseated and was not feeling good and little bit of fever and I told them about it. I just need to know what to do. I have fever 102.6 and I feel nauseated. I felt like I got COVID again and I know I don't but it gave me that feeling. On an unknown date, the patient underwent lab tests and procedures which included body temperature which result showed fever 102.6 (unit not provided). The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1401803
Sex: F
Age:
State: WI

Vax Date: 02/23/2021
Onset Date: 02/25/2021
Rec V Date: 06/16/2021
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: 2 days after vaccine administration. Swollen upper lip with a fever blister; 2 days after vaccine administration. Swollen upper lip with a fever blister; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6209), via an unspecified route of administration in the Arm right on 23Feb2021 at 13:45, as a single dose for COVID-19 immunisation. The patient allergic to penicillin, macrodantin and morphine. The patient's concomitant medications included verapamil hydrochloride (VERAPAMIL [VERAPAMIL HYDROCHLORIDE]) 180 mg for unspecified indication (start and stop date were not reported). Historical vaccination included Flu shot and Pneumonia shot in the Right arm on 29 Jan 2021. The patient did not test for COVID-19 after vaccination. On 25Feb2021 at 06:00, the patient experienced 2 days after vaccine administration swollen upper lip with a fever blister. The patient did not receive any treatment for the events. All the events were non-serious. The outcome of all the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: VERAPAMIL [VERAPAMIL HYDROCHLORIDE]

Current Illness:

ID: 1401804
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: tired; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received second dose of BNT162B2 (BNT162B2; Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown) on an unspecified date as first dose for covid-19 immunization. On an unspecified date, after vaccination the patient felt tired. It was reported that a female patient was unable to exercise the day following her second covid-19 vaccine dose because she was extremely tired. She indicted she felt better the next day. Reporter was not comfortable in a setting with 20 other people to ask for details (nor was it appropriate), so unsure that which brand she received. Many other attendees chimed in to give details of their friends /family members experience with covid-19 vaccine. They indicated that the second dose caused more AEs and that they felt it was worse if the person had been previously infected with the covid virus. None indicated the brand received. Reporter had no further details to provide. Outcome of the event was unknown. Information on Lot/Batch number has been requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1401805
Sex: M
Age:
State: MI

Vax Date: 01/25/2021
Onset Date: 02/02/2021
Rec V Date: 06/16/2021
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: temporary delayed loss of taste; This is a spontaneous report from a contactable physician. A 67-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247; formulation: solution for injection; Expiration date: unknown), via an unspecified route of administration in left arm on 25Jan2021 19:00 as single dose for covid-19 immunisation. The medical history included Covid-19 (had COVID-19 in early November). The patient did not take concomitant medications (no other medication in two weeks). The patient previously took toradol and experienced drug allergy. No other vaccine in four weeks. No COVID prior vaccination and patient not tested for COVID post vaccination. On 02Feb2021, nine days after the vaccine, Patient lost most of his sense of taste for two days. (Patient had COVID-19 in early November and did not lose sense of taste at that time). He have heard of 4 other people at his employment who had previously had COVID-19 and developed this same reaction after the vaccine, temporary delayed loss of taste. Obviously this is not a serious reaction, just a peculiar one. He was unable to find this on the Internet. The patient did not received treatment for the adverse event. The outcome of the event was recovered on an unspecified date in 2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient

Other Meds:

Current Illness:

ID: 1401806
Sex: M
Age:
State: MI

Vax Date: 01/25/2021
Onset Date: 02/03/2021
Rec V Date: 06/16/2021
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: temporary delayed loss of taste; This is a spontaneous report from a contactable physician. A 67-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in left arm on 25Jan2021 at 19:00 (Lot number EL3247, Expiry date: Unknown) as 1st dose, single dose for COVID-19 immunisation at a hospital. Medical history included COVID-19 (in early November and did not lose sense of taste at that time) and allergic to Toradol. The patient's concomitant medications were not reported. The patient did not receive any other vaccination within 4 weeks and no medications were received within 2 weeks of vaccine administration. The patient was not tested for COVID after vaccine administration. On 03Feb2021, nine days after vaccine administration, the patient lost most of his sense of taste for two days. This was not a serious reaction just a peculiar one. There was no treatment received for the reported event. Outcome of the event was reported as recovered on an unknown date in Feb2021. Follow-up (04Jun2021): This follow-up is being submitted to notify that follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient

Other Meds:

Current Illness:

ID: 1401807
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 06/16/2021
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: temporary delayed loss of taste; This is a spontaneous report from a contactable Physician. This Physician reported for similar events for 4 patients. This report is 4th of 4 reports. This physician reported for a patient of an unknown age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown), via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Patient medical history was reported as COVID-19 positive. Patient concomitant medications were not reported. On an unknown date patient was temporary delayed loss of taste. Outcome of the event was unknown. Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021205778 same drug and AE, different patient

Other Meds:

Current Illness:

ID: 1401808
Sex: F
Age:
State: IN

Vax Date: 02/06/2021
Onset Date: 02/07/2021
Rec V Date: 06/16/2021
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: weakness/ little weak; legs were shaky; legs suddenly gave out in the kitchen and she could not get up or pull herself up/ severe leg weakness; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 06Feb2021 at 16:30 as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on 15Jan2021 for COVID-19 immunization and she was mostly in bed, sleeping for 2 days and felt extremely tired but was ok after resting. On 07Feb2021 at 14:00 the patient reported that her legs suddenly gave out in the kitchen and she could not get up or pull herself up and she had severe leg weakness. Because of her weakness, she stayed on the floor from 14:00 to 21:00. She asked a friend to come over and pull her up and she had to scoot to the backdoor to let her friend in. Her friend was unable to pull her up. About 15-20 minutes after her friend had arrived, her legs were still shaky, but she was able to pull herself up. she could not get up or sit up for 6 hrs and She did not lose consciousness, she tried to reach the fridge handle to pull herself up, could not do it from 2 pm to 9 pm. After that, she drank Gatorade (electrolyte) and ate food because she did not eat anything the whole time she was on the floor. She mentioned that she was weak for 2 days. After a couple of days, she was ok again. She reported that the AEs she experienced for the 2 doses were similar. However, she did not felt weakness since she was sleeping excessively. She said her AEs were so severe that she had to report it. She wanted to know if she could get the Pfizer vaccine if there may come a time that additional doses are needed to be covered for the new strains of the virus. She heard on the news about third shot of Pfizer's vaccine and was wondering if she could receive a third booster shot once it is studied. She also wanted to know if she could switch to another kind of COVID-19 vaccine (like Moderna) after completing the Pfizer COVID-19 vaccine vaccination series. Patient took Gatorade as a treatment for the events. The outcome of all events was recovered on an unspecified date in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1401809
Sex: U
Age:
State: GA

Vax Date: 03/11/2021
Onset Date: 03/26/2021
Rec V Date: 06/16/2021
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: my niece was diagnosed with Covid and I had a lot of contact with her in the week before she was tested; feel bad; This is a spontaneous report from a Pfizer-Sponsored program Pfizer.com. A contactable consumer of unspecified age and gender reported that he/she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he/she got second shot 3 weeks ago. His/her niece was diagnosed with Covid and patient had a lot of contact with her in the week before she was tested (she had no symptoms). On an unknown date patient felt bad, but it could have been from the weather. Also patient's mother started having chest pains and asked patient to take her to the hospital and it was Covid. The patient wanted to ask if he/she should get tested again for records sake or not. The outcome of all events was unknown. No follow-up attempts were possible, Information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1401810
Sex: M
Age:
State: NJ

Vax Date: 03/02/2021
Onset Date: 03/02/2021
Rec V Date: 06/16/2021
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: Positive Covid test; high fever; Cough; This is a spontaneous report from a contactable consumer or other non health care professional(Patient himself). A 57-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Right on 02Mar2021 18:00 (at the age of 57-year-old) as 1st dose, single dose for covid-19 immunisation at hospital. Medical history included bronchitis in the past and was slightly overweight, cough, but was told that it was probably from reflux. There were no concomitant medications. Patient was not on other Products. Patient did not take any other vaccinations within four weeks prior to the covid-19 immunisation. No AE experienced following prior vaccinations. No Family Medical History Relevant to AE. Patient's Medical History including any illness at time of vaccination was none. No History of all previous immunization with the Pfizer vaccine considered as suspect. On 02Mar2021, the patient experienced high fever, cough. He received his 1st dose on Tuesday, and since then he has had a high fever started in the evening he got the vaccine and cough. Patient said that it goes away when he takes Advil or Tylenol, then it comes back. He took cough medicine for a day or so, and now his cough just comes and goes. He would say that his cough has improved. The day before he got the vaccine, he had his annual visit with his cardiologist, and he had a cough that day, but was told that it was probably from reflux. He did not have a fever on Monday, or on Tuesday before getting the vaccine. He called his doctor and told him what was going on and his doctor recommended that to get tested for Covid. He went to an urgent care and got tested today at 2pm and patient had tested positive for covid test. Reported AE does not required visit to Emergency room. Therapeutic measures were taken as a result of events included Z-pack, Vitamin D, Vitamin C, Zinc, and Quercetin. The patient underwent lab tests and procedures which included body temperature: 99.1-101.6 degrees fahrenheit on an unknown date and COVID-19 rapid POC test results positive on 05Mar2021. Patient asked whether he get the 2nd dose in 3 weeks or does he need to start all over again and Stated that his 2nd dose was scheduled for 23Mar2021. Investigation Assessment was reported. There was a Product Complaint. The outcome of the event fever was not recovered, cough was recovering, covid-19 was unknown. Follow-up (08Mar2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that, new information included the other reporter details were updated. Description of Product Complaint: Patient Calling about the Covid 19 vaccine. He received his 1st dose on Tuesday, and since then he has had a high fever and cough. States that he went in today and had the rapid test for Covid and it was positive. Stated that the day before he got the vaccine, he had his annual visit with his cardiologist, and he had a cough that day, but was told that it was probably from reflux. He did not have a fever on Monday, or on Tuesday before getting the vaccine and he called his doctor and told him what was going on and his doctor recommended that he get tested for Covid. He went to an urgent care and got tested today at 2pm. The rapid test was positive. They also did the PCR test, which he won't get results of for about 48 hours.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm