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: 1427114
Sex: F
Age: 29
State: PA

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 06/25/2021
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: Defective retractable syringe. Syringe retracted before dose was fully administered and over half of the dose did not make it into the patient's arm. Administered another full dose to the patient with no issue.

Other Meds:

Current Illness:

ID: 1427115
Sex: F
Age: 72
State: MT

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 06/25/2021
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: Vesicare zaleplon Ambien

Symptom List: Anxiety, Dyspnoea

Symptoms: knee and shoulder pain, insomnia, low back pain, chronic pain, fatigue, sleep related leg cramps

Other Meds: metformin 1,000 mg tablet lisinopril 10 mg tablet lovastatin 20 mg tablet Tylenol-Codeine #4 300 mg-60 mg tablet glipizide 10 mg tablet aspirin 81 mg tablet,delayed release multivitamin tablet Voltaren 1 % topical gel tizanidine 2 mg capsul

Current Illness: Benign paroxysmal positional vertigo Left anterior fascicular block Polyp of colon Nausea and vomiting Fatigue Hair loss Tachycardia Insomnia with sleep apnea Adjustment disorder with mixed emotional features Osteoporosis Nephrolithiasis Thrombocytosis Paresthesia (numbness/tingling) Sleep related leg cramps Dry skin Nocturia Sensorineural hearing loss Knee pain Shoulder pain Low back pain Edema of lower extremity Insomnia Osteopenia Urinalysis = abnormalabnormal urine cytology 2/12 Liver enzymes abnormal Renal insufficiency syndromeSCT30989003) (Current) Hyperkalemia Obesity Knee pain Chronic back pain Hyperlipidemia Diabetes mellitus type 2 Hypertension Hand pain

ID: 1427116
Sex: M
Age: 27
State: AZ

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 06/25/2021
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: Administered Lot#047B21A, but lot#008C21A(exp: 5/20/2021) was logged on forms.Lot#047B21A expired on 5/13/2021.

Other Meds:

Current Illness:

ID: 1427117
Sex: M
Age: 23
State: UT

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 06/25/2021
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: Error: Booster Given Too Early

Other Meds:

Current Illness:

ID: 1427118
Sex: F
Age: 51
State: MD

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies: None of I know of

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

Symptoms: After my first shot of Pfizer, I have been feeling short of breath, heart raising, rashes, brain fog, etc.

Other Meds: No

Current Illness: No

ID: 1427119
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: had very bad symptoms and they are not well until today; This is a spontaneous report from a non-contactable consumer. A female patient (sister) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), route of administration, start and stop date, batch/lot number and dose were not reported, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced had very bad symptoms and they are not well until today. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021703343 same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1427120
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: He had the strength in his legs to be able to stand up without pushing himself up, something he has not been able to do for some time (uses wheelchair and lift chair); He got sick; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's spouse). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history included multiple sclerosis (ongoing) and wheelchair user (ongoing). Concomitant medications were not reported. The patient got sick for 24 hours after receiving 2nd injection like many others. 24 hours later, patient was just fine. However, he had the strength in his legs to be able to stand up without pushing himself up. It was some-thing he has not been able to do for some time (uses wheelchair and lift chair). The reporter stated that this was a huge surprise. It lasted for 5 days and was very nice little side effect even if it lasted only 5 days. The outcome of sickness was recovered. Information regarding the lot/batch number has been requested.

Other Meds:

Current Illness: Multiple sclerosis; Wheelchair user

ID: 1427121
Sex: U
Age:
State: PA

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 06/25/2021
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: My whole body was numb for 1hr and 30 min; unsteady balance; confusion; palpitations; sob; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 25May2021 as dose number unknown, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced Later on in the day patient experienced severe side effects that was on listed patient whole body was numb for 1hour and 30 min, unsteady balance, confusion, palpitations, and sob. patients understand the sob because had asthma but otherwise perfect health. The outcome of event was unknown. Information on the lot/batch number has been requested. ; Reporter's Comments: Reporter provided verification of contact address on 11Jun2021 CEP D #3110

Other Meds:

Current Illness:

ID: 1427122
Sex: U
Age:
State:

Vax Date: 06/11/2021
Onset Date: 06/01/2021
Rec V Date: 06/25/2021
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: Lost my sense of taste and smell; Lost my sense of taste and smell; Body is achy; I felt pretty lousy; Very tired; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0181; Expiration Date was reported as 11Jun2021), via an unspecified route of administration on 11Jun2021 (reported as Friday evening) as single dose for COVID-19 immunization. Medical history included cough from unspecified date in Jun 2021 reported as about a week prior to getting the shot but get bronchitis a lot and gets sick at anything but had no other symptoms other than cough, bronchitis. The patient concomitant medications were not reported. It was reported that the patient took vaccine on Friday evening and felt pretty lousy all weekend and actually had almost every symptom of COVID right now, so she asked what happen if got the shot if you already had COVID. Patient stated that she lost sense of taste and smell, body is achy, very tired Patient stated that she get sick at anything but had no other symptoms other than cough and usually gets bronchitis. But then after the vaccine I started getting all the mentioned symptoms. The outcome of the events was unknown. Consumer was unwilling to complete the report. Hence, limited information available. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1427123
Sex: F
Age:
State: WA

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 06/25/2021
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: Chest pressure/I felt like the chest was being squeezed and the chest discomfort; chest pain or pressure like the chest is being squeezed; Tiredness/if I do exercise, I feel easier to be tired; my physical strength is not as before; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient) reported for herself. A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0171, Expiration date: Aug2021) via an unspecified route of administration, administered in left arm on 30Apr2021 (age at vaccination was 49 years) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. The patient stated she had a heart infection in which was not at 25 when she was in her teen years. She meant it was like 30 years ago, she had a heart infection more than 30 years ago. But she did a test, that was one couple of years ago. Doctors said her heart was fine. The heart infection was not diagnosed, it was not identified by doctor. She just didn't remember what was the name but according to symptoms, the doctors said it should be a heart infection. The patient's concomitant medications included Vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 09Apr2021 (age at vaccination was 49 years) as 1st dose, single for COVID-19 immunization and there were no reactions reported. The patient said she got the second dose of the Pfizer COVID Vaccine last 30Apr2021 and on 01May2021, the second day after 12 hours noon, she experienced side effects which is chest pain or pressure like the chest is being squeezed. After the first of few days after the second dose, she had a chest pressure, and later she had known from news that was the inflammation of chest, like something could be, like a mild 'cardioditis'. She didn't know what that was. She went to see doctor. She had it a few days after second dose. Again, chest pressure. She felt like the chest was being squeezed and the chest discomfort. And after that it had been so long. It had been one and a half month now. What she noticed was her physical strength was not as before, like when she did exercise, she used to do fine. But now if she did exercise, she felt easier to be tired. She had chest pressure and tiredness after even now so far after second dose, one and a half month now. Compared to before, her physical strength decreased. Like when she used to do exercise, she did not feel easy but now she felt easier to be tired after exercise or during exercise. She wanted to know what she should do. The patient stated that she didn't have other medical, after a few days. After like a one couple of weeks. She felt okay but she felt until now, compared before the vaccine, her physical strength, like she used to do a lot of exercise she didn't feel tired. Now it was easier to feel tired. The patient asked regarding the meaning of expiration date and whether that means she needed to get a shot again after August. The patient was informed that the product should not be used after expiration date. The patient was informed about the role of Pfizer and also informed that Pfizer Medical Information was the right department to answer the question. The patient was informed about the role of Pfizer. The patient did not receive any prior vaccinations before the Pfizer vaccine. The outcome of the events was unknown. Follow-up attempts are possible. Further information is expected.

Other Meds:

Current Illness:

ID: 1427124
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: fever; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient, self-reported) via Pfizer sales representative. A 13-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on unspecified date, as a single dose for COVID-19 immunization. The patient reported that 2 sisters experienced similar symptoms. On an unspecified date, the patient experienced fever chills and fatigue which resolved in 24 hours. The events took place after use of product. The reporter did not wish to be contacted for follow-up. Outcome of the events was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1427125
Sex: M
Age:
State: MA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 06/25/2021
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: He felt a little pain in his neck and his legs felt heavy.; He felt a little pain in his neck and his legs felt heavy.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0176), via an unspecified route of administration on an unspecified date in May2021 (at the age of 68-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included nephrolithiasis (caller reported that in 28 years he has missed 2 days of work with kidney stones). The patient's concomitant medications were not reported. He do not drink or smoke, and walks 3-4 miles daily 5-7 days per week. On an unspecified date in May2021, the patient experienced he felt a little pain in his neck and his legs felt heavy, he felt a little pain in his neck and his legs felt heavy. Patient reported that he received the first dose of the Covid-19 vaccine about a month ago and about 2 weeks ago on Wednesday, he got the second dose. Caller reported that he received the first dose of the Covid-19 vaccine about 3 weeks before the second dose. The clinical outcome of the he felt a little pain in his neck and his legs felt heavy, he felt a little pain in his neck and his legs felt heavy were unknown. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1427126
Sex: M
Age:
State: FL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 06/25/2021
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: PSA levels going up after the Pfizer Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 75-year-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Jan2021, as 2ND DOSE, SINGLE for COVID-19 immunisation. He reports that he had both doses of the Pfizer Covid-19 vaccine within the month of Jan but could not tell the exact dates. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection) in Jan2021 as historical vaccination as 1st dose, single dose for covid-19 immunisation. The patient's PSA levels going up after the Pfizer Covid-19 vaccine, on an unspecified date. The patient reports that, he continues to see his urologist, but he was "just curious". The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427127
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: Burning sensation; Pain in the right shoulder and armpit; Pain in the right shoulder and armpit; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date (at the age of 72-year-old),as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date after receiving the 1st dose, the patient experienced burning sensation, pain in the right shoulder and armpit.The patient would like to know about taking the second shot, would it be needed after 42 days. Outcome of the events was unknown Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427128
Sex: F
Age:
State: CA

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 06/25/2021
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: Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIOECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 11Jun2021 09:45 as second dose, single for covid-19 immunization. (Vaccine Administered at Military Facility: No) (Vaccination facility type: clinic by public health department). Medical history included ongoing Hereditary coproporphyria, ongoing arthritis and degenerative disc disease of spine , intervertebral disc degeneration from an unknown date and unknown if ongoing. Concomitant medication included baclofen (BACLOFEN) taken arthritis and degenerative disc disease of spine from an unspecified start date and ongoing. Has been taking 6 years. Nerves messed up in spinal column from L1-S1. The patient and her son just got second doses on 11Jun2021 and she reported side effects he experienced she did not have a reaction, on 11Jun2021 around 13.00 she had sore arm. She was adds she do not want to crying, she got lab work reports got back today. And her doctor was told she may have blood cancer because blood cells are severely abnormal different sizes, shapes, colors and so many of them and he has not seen this in a very long time. She was also states he also said something about smudge cells. AE not resulted to ER visit and physician office visit. The outcome for the event was resolved on 11Jun2021. Follow up attempts are needed. Further information has been requested.

Other Meds: BACLOFEN

Current Illness: Arthritis (Verbatim: arthritis and degenerative disc disease of spine); Hereditary coproporphyria (Verbatim: Hereditary coproporphyria)

ID: 1427129
Sex: F
Age:
State:

Vax Date: 03/13/2021
Onset Date:
Rec V Date: 06/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Headache; Chills; She missed her appointment for her second dose; This is a spontaneous report from a contactable consumer (patient's daughter). 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 13Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache, chills, she missed her appointment for her second dose. It was stated that now patient would like to get her second dose but she do not know if she needed to start over the vaccination series and what she should do. She received response that second dose of Pfizer-BioNTech vaccine should be administered as close to the recommended interval as possible, but not earlier than recommended (3 weeks [Pfizer-BioNTech]). But if it was not possible to give the second dose at 3-weeks and a delay could not be avoided, it might be given up to 6 weeks (42 days) after the first dose. If the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There were only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time. Stated she was working right now and the reason she called was that she do not want to wait any longer. The clinical outcome of the headache, chills, she missed her appointment for her second dose were unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427130
Sex: M
Age:
State: CA

Vax Date: 06/13/2021
Onset Date: 06/13/2021
Rec V Date: 06/25/2021
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 right arm pit is more swollen than the left arm pit. He says there are no bumps in the arm pit, just swelling./swollen and there is little bumps present.; Concerned about the inflammation; That evening he had pain in his arms; and body aches which today have resolved; This is a spontaneous report from a contactable consumer (patient) reported for himself for the 1st Dose administered. A 40-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 13Jun2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the right arm pit is more swollen than the left arm pit and said there are no bumps in the arm pit, just swelling. swollen and there is little bumps present. (swelling on 15Jun2021 with outcome of not recovered , that evening he had pain in his arms on 13Jun2021 with outcome of recovered , and body aches which today have resolved on 13Jun2021 with outcome of recovered , concerned about the inflammation on 15Jun2021 with outcome of not recovered.

Other Meds:

Current Illness:

ID: 1427131
Sex: F
Age:
State: TX

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: she "has numbness" and "tingling"in her left and right hands; It feels like pins and needles/tingling in her left and right hands; This is a spontaneous report received from a contactable consumer (patient herself) via Medical Information Team. A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jun2021 as 2nd dose, single (at the age of 49-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single for COVID-19 immunization and had no reaction. Patient received her 2nd Pfizer vaccine a day before (14Jun2021) and stated today (15Jun2021) she had numbness and tingling in her left and right hands, but mostly in her right hand. It felt like pins and needles, like when you leave your arm or leg in a position too long. The outcome of the events was unknown. Follow up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1427132
Sex: F
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: First the left Jaw; joints knee hurt; dry mouth; throat could not swallow; Chill hot cold; Heartfelt; This is a spontaneous report from a contactable other HCP reported for the patient in response to HCP letter [sent to physician] via follow-up letter. A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left jaw when it starts. 62 days getting worse left side of jaw also it starts every not about midnight. First the left jaw, joints knee hurt, dry mouth, throat could not swallow, heartfelt and chills hot cold. It was reported that, 'Must take pain xxx tramadol' and 'adult 4 CBD oil'. This has been 62 days doctor ER knew wat to do. Same symptoms every night for 62 days the patient withheld same issue only one dose Pfizer. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1427133
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: having body aches all over; body aches all over, neck; body aches all over shoulders; body aches all over,toes and under her feet; Pt reported being unsure of the headaches; This report is received from Xeljanz C&P Program. This is a spontaneous report from contactable other HCP and consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included methylprednisolone (Manufacturer unknown), for unknown indication. On an unspecified date the patient reported having body aches all over, body aches all over neck, body aches all over shoulders, body aches all over, toes and under her feet and patient also reported being unsure of the headaches on an unspecified date. It was reported as, the patient reported being unsure of the headaches were from not enough water. no exact dates or further details. The patient underwent lab tests and procedures, and patient reported her rheumatologist advised all of her blood work was normal. The outcome of events was unknown. Follow up needed; Information on the lot/batch number has been requested.

Other Meds: METHYLPREDNISOLONE

Current Illness:

ID: 1427134
Sex: M
Age:
State: SC

Vax Date: 06/05/2021
Onset Date: 06/01/2021
Rec V Date: 06/25/2021
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: his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; his hands and feet and legs were just itching and burning all day almost; little pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 51-years-old male patient received bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 05Jun2021 09:41 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (51-years-old at the time of vaccination). The patient medical history was not reported. Concomitant medication included ubidecarenone (COQ-10) taken for an unspecified indication. Patient had no prior vaccination. No family history of itchy hands and legs. The patient previously took first dose of BNT162B2 on 15May2021 (Age-51-year-old) (Batch/Lot Number: ER8733) for covid-19 immunisation with no reaction (No events reported). Consumer stated, he had second shot Pfizer Covid vaccine on 05Jun2021 and when he woke up that morning his hands and feet and legs were just itching and burning all day almost in jun2021 (About two days, 14Jun2021 (not clarified)).Consumer was informed about Pfizer Medical Information department. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.

Other Meds: COQ-10

Current Illness:

ID: 1427135
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: I have been having like vivid dreams every night; This is a spontaneous report from a contactable consumer (patient) reported that: An unspecified age and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730; Formulation: solution for injection: expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE and second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0161) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I was just wondering I got the Pfizer Covid 19 vaccine. I got two doses and I have been having like vivid dreams every night on an unspecified date''. The patient did not know like if other people were reporting that and was just wondering like know if other people were reporting it. Patient was enquiring that was said like it eventually goes away or was it continue for a long period of time. The patient glad to report what side effect the patient having but the main concern was to know do they have like other people that reported it and if so like did it eventually go away. Also enquiring about was their experience that it went away after a month or two, or does it keep continuing. The patient just wanting to get some information because right now patient having strange dreams, they were not like before and some of them were very scary. The outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1427136
Sex: F
Age:
State: SC

Vax Date: 06/13/2021
Onset Date: 06/14/2021
Rec V Date: 06/25/2021
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: Muscle ache; big bumps, were welting up; Have bumps all over me; Itching; Headache; Fever; Chills and sweating; Chills and sweating; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in arm left on 13Jun2021 at 14:00 (at the age of 39-years-old) as 1st dose, single for COVID-19 immunization at Pharmacy/Drug Store. The patient reported that she took vaccine as she was having smell and taste issue. The medical history of the patient included Benign cranial hypertension from May2021 and ongoing (Optic nerve in left eye was severely damaged. Patient would see Neurologist in August. Eye specialist diagnosed her with this), COVID from Oct2020 to an unknown date and Nerve damage in the brain and eye from Covid from Oct2020 to an unknown date. The concomitant medications of the patient included acetazolamide (ACETAZOLAMIDE) taken for Benign cranial hypertension from May2021 and was ongoing (patient had to wait for MRI before staring this medication) and phentermine (PHENTERMINE) taken for Appetite suppressant weight loss from Feb2021 and was ongoing (stated that this was the generic for Adipex). The history of all previous immunization with the Pfizer vaccine considered as suspect, any other vaccines prior 4 weeks of suspect vaccine and additional vaccines administered on same date of the Pfizer suspect were reported as none. The AE(s) following prior vaccinations was reported as none. The Family Medical History Relevant to AE(s) was reported as none. The patient experienced fever, headache and chills and sweating on 14Jun2021 16:00 and had bumps all over and itching on 15Jun2021, and muscle ache on unspecified date. Patient took the Pfizer vaccine on Sunday. It was the first dose. She said she was having a severe reaction from it. She has bumps all over her. The reporter confirmed the itching was worse, stated that everywhere she scratched, bumps came up. It was getting worse. They were everywhere but on her face. They were big bumps. They were welting up. Patient thought they were going into hives and said again they were not on her face. Patient added that she had fever and headache. She had to take Tylenol last night. The fever and headache started yesterday about 16:00. She was having the chills thinking she was about to freeze. When she got home she had to get under the cover. She checked her temperature it was only 98.2. Then an hour or so later after taking the Tylenol and from getting from under the covers she thought she was sweating. She checked her temperature at about 20:00. After she took the Tylenol she was able to come out of the covers. The patient underwent lab tests and procedures which included temperature 98.2 on 14Jun2021 and stated that she did not have any other tests for the events other than the temperature. Patient only took Tylenol. Patient did not go to physician office or emergency room. She had an appointment 15Jun2021 (today) at urgent care at 11:00. The report was not related to a study or program. Patient stated that she was having a smell and taste issue and still having them. People said that if she had the Pfizer vaccine, it would help because people are regaining all of their smell and taste. She had Covid back in Oct2020 and her smell and taste came back partially. She had nerve damage from when she had covid in the brain and eye from Covid. She thought she would have the vaccine to try and help, because she as told if the infection was still in her body then this will help, but seems things got much worse. She thought maybe she would wait and see what the second dose would do, but the first one was really bad. She got very sensitive. She felt that it was much worse because she was running a lowgrade temperature, muscle aches, and headaches. The first dose was doing really bad things right now. The outcome of the events have bumps all over me and itching was reported as not resolved and the outcome of the events welting up, fever, headache, muscle ache and chills and sweating were reported as unknown. Information on Lot/Batch number has been requested.

Other Meds: ACETAZOLAMIDE; PHENTERMINE

Current Illness: Hypertension NOS (Verbatim: Benign cranial hypertension)

ID: 1427137
Sex: M
Age:
State: FL

Vax Date: 03/28/2021
Onset Date: 04/20/2021
Rec V Date: 06/25/2021
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: fever; chills; lethargy; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EP7534), via an unspecified route of administration in left arm on 28Mar2021 at 10:00 (age at vaccination 20-year-old), as a 1st dose, single for covid-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient do not have any known allergies. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 12:00, patient experienced fever, chills, and lethargy. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Polymerase chain reaction test (Nasal Swab): negative on 22Apr2021, 25Apr2021 and 26May2021. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1427138
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: having tingling and numbing on the whole left side of my body and my right arm; The first one it was just a little bit on my foot; having tingling and numbing on the whole left side of my body and my right arm; The first one it was just a little bit on my foot; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number was not reported) and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number was not reported) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having tingling and numbing on the whole left side of body and right arm; the first one it was just a little bit on foot. Patient started experiencing like numbness in the left side about a week after the 1st dose. The reporter stated that the first one, it was just a little bit on foot (Confirmed experienced after first shot) and the second one was whole left side (Confirmed experienced after second shot). Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427139
Sex: F
Age:
State:

Vax Date: 06/15/2021
Onset Date: 06/01/2021
Rec V Date: 06/25/2021
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: She started having fever like 101 and I give her Tylenol, it helped a little bit; she started having high fever again at around 5'Oclock came back around 102; she is shivering a lot as well; She started having fever like 101 and I give her Tylenol, it helped a little bit; she started having high fever again at around 5'Oclock came back around 102; she is shivering a lot as well; She started having a lot of sweats; she felt warm and sweat; this morning she woke up kind of warm with 99.9; She started having a lot of sweats; she felt warm and sweat; this morning she woke up kind of warm with 99.9; she had also Diarrhea; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old female patient received second dose of BNT162B2 (Solution for injection, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 15Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at age of 23 years) for COVID-19 immunization and no reaction was reported on previous exposure to vaccine. On 15Jun2021, the patient started having a lot of sweats; she felt warm and sweat; and morning she woke up kind of warm with 99.9. She started having fever like 101 and was given TYLENOL (NDC/UPC number: Unknown, Expiry date: Unknown) which helped a little bit; she started having high fever again at around 5'O clock came back around 102; she was shivering a lot as well. She also had diarrhea and had taken her to the emergency room. Reporter stated, "her daughter had Pfizer, the second shot yesterday afternoon and last night she started having a lot of sweats. So, she felt warm and sweat which we thought was going to pass. But then, morning she woke up kind of warm with 99.9 and then she thought it was going to pass. But then she started having fever like 101 and she gave her TYLENOL (captured as suspect), it helped a little bit. But that afternoon she started having high fever again at around 5'O clock came back around 102. So, she took another 2 TYLENOLs, and it was already 10:17, was not sure, 10:25 and she just check out her temperatures she was 102.3. So, her question was should she take her to emergency room because she was shivering a lot as well". Reporter was requested to take the patient to the nearest emergency room or contact a healthcare provider. Reporter was informed to contact Pfizer Medical Information Department as well. However, the department was closed currently. Further probing could not be done as reporter did not want to share further information. Hence, limited information was available over the call. Reporter seriousness was reported as unspecified. Outcome of the event sweating and diarrhea was unknown, whereas other events was not recovered. Information related to batch/Lot no. was requested.

Other Meds:

Current Illness:

ID: 1427140
Sex: F
Age:
State: MI

Vax Date: 06/15/2021
Onset Date: 06/01/2021
Rec V Date: 06/25/2021
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: I could walk those miles, I can breath better/ there was positive everything today there was no negative in what I am feeling today/ I feel so excited that I feel so good; This is a spontaneous report from a contactable female consumer (patient) reported for herself. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0182) via an unspecified route of administration on 15Jun2021 10:30 as 2nd dose, single for COVID-19 immunisation. Medical history included COPD, asthma, epileptic, depression all from an unknown date and unknown if ongoing. Concomitant medications included buspirone (BUSPIRONE) 10 mg taken for depression, start and stop date were not reported; topiramate (TOPAMAX) 200 mg twice a day taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) 15 mg once a day taken for an unspecified indication, start and stop date were not reported; lamotrigine (LAMICTAL) (Lamictal 150 mg, this is at the evening, and then I get 100 in Lamictal) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (LOT no.: EW0176) on 25May2021 for COVID-19 immunisation. On an unspecified date the patient reported that I had my second vaccination today and a lot have side effects and I had none of those today it was the opposite. I had lot of miles up to 4 miles I have to walk I had no choice. I could walk those miles, I can breathe better. I guess there was positive everything today there was no negative in what I am feeling today, and I find myself. That is just gone away. I just have my daughters know that I was going to let you guys know this is such the positive thing I got (Incomplete word) this morning. I am just excited that I feel so good. The clinical outcome of the event was unknown.

Other Meds: BUSPIRONE; TOPAMAX; OXYBUTYNIN; LAMICTAL

Current Illness:

ID: 1427141
Sex: M
Age:
State: VA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/25/2021
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: Sharp chest pains, shortness of breath.; Sharp chest pains, shortness of breath.; This is a spontaneous report from a contactable consumer (patient reported on himself). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN0199, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00, as 1st dose, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: RE8734, Pfizer NTEC), via an unspecified route of administration, administered in left arm on Mar2021 07:00 (at the age of 51-years-old), as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the hospital. Medical history included abdominal discomfort from an unknown date. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]), pseudoephedrine hydrochloride (SUDAFED 12 HOUR), glucosamine (GLUCOSAMINE), l-arginine (arginine), ascorbic acid (VITAMIN C ACID) and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously took PCN (penicillin nos). 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 been tested for COVID-19. In Mar2021, the patient experienced sharp chest pains and shortness of breath. The patient did not receive any treatment. The clinical outcome for the events was not recovered.

Other Meds: PROTONIX [OMEPRAZOLE]; SUDAFED 12 HOUR; GLUCOSAMINE; L-ARGININE [ARGININE]; VITAMIN C ACID; VITAMIN D [ERGOCALCIFEROL]

Current Illness:

ID: 1427142
Sex: F
Age:
State: NV

Vax Date: 05/23/2021
Onset Date:
Rec V Date: 06/25/2021
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: The first shot, I just had sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736, Expiration date: Jul2021) intramuscularly on the right arm (shoulder) on 23May2021 (at the age of 58-year-old) as single for COVID-19 immunization. Medical history of the patient included rheumatoid arthritis (2010- not clarified), and asthma, it might have been, patient haven't had wheezing and it might have been about 2 weeks ago. Concomitant medication included Diclofenac Sodium Topical Gel, 4 times a day (1%, Atopic cream) taken for rheumatoid arthritis, Prednisone 5 mg once a day taken for rheumatoid arthritis, Hydrocodone 10 mg taken for rheumatoid arthritis, Albuterol (Salbutamol) taken for asthma. Patient did not receive any prior vaccinations within 4 weeks. On an unspecified date, the patient had sore arm after the first dose. Patient did not receive any treatment for the event. The outcome of the event was unknown.

Other Meds: DICLOFENAC SODIUM; PREDNISONE; HYDROCODONE; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1427143
Sex: F
Age:
State: NV

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: have a big bump on the shot site, knot; have a big bump and redness on the shot site; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscularly, administered in right deltoid (right shoulder as reported) on 14Jun2021 (Lot Number: EW0180; Expiration Date: Aug2021) as dose 2, single at the age of 58-year-old for covid-19 immunization. Historic vaccine was bnt162b2 (PFIZER COVID-19 VACCINE), intramuscularly, administered in right deltoid (right shoulder as reported) on 23May2021 (Lot Number: ER8736; Expiration Date: Jul2021) as dose 1, single at the age of 58-year-old for covid-19 immunization and experienced sore arm. Medical history included rheumatoid arthritis from 2010 to an unknown date (Diagnosis date: 2010), asthma from an unknown date. The patient had not had no wheezing and it might had been about 2 weeks ago. There was no prior vaccinations within 4 weeks. Concomitant medications included diclofenac sodium (topical gel), prednisone, and hydrocodone, all taken for rheumatoid arthritis; salbutamol (ALBUTEROL) taken for an unspecified indication, all start and stop date were not reported. The patient just had one concern. She got the Pfizer, her second shot yesterday (14Jun2021) and today (15Jun2021) she had a big bump and redness on the shot site. Was that a normal reaction? After the second shot. The first shot, the patient just had sore arm. The second shot she was experiencing this knot and redness. The patient was still experiencing the issue, It's a knot and its red. Therapeutic measure were not taken as a result of events. The outcome of events was not recovered.

Other Meds: DICLOFENAC SODIUM; PREDNISONE; HYDROCODONE; ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1427144
Sex: F
Age:
State: CT

Vax Date: 06/13/2021
Onset Date: 06/14/2021
Rec V Date: 06/25/2021
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: Arm pain; Stomach pain; I feel like vomiting; I feel like throwing up; This is a spontaneous report from a contactable consumer (patient father). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiration Date: 13Jun2021), via an unspecified route of administration, administered in left hand on 13Jun2021 as 1st dose, single dose for covid-19 immunisation. Medical history included was none and there were no concomitant medications. On 14Jun2021, Reporter stated that My daughter, she got the Pfizer COVID vaccine. She has the problem. The arm pain, which was normal because she passed all dosage stage however she keeps complaining about the stomach pain and then she says I feel like throwing up and which was, vaccination was happen on Sunday but she was keeps complaining like on 14Jun2021 Monday night, 15 Jun2021Tuesday night and also 16Jun2021 night and I thought let me update you. Is it normal or something different? She has not thrown up yet but she feel like throwing up and she was having pain in her stomach. She said, I feel like vomiting but no vomit so far but stomach pain still going on. Reporter stated that, I would like to know was that normal or she should checked by the doctor or she should wait one or two days more to get better or any other side effects which needs to be check right away. I mean she do not have any like fever or feel like emergency or anything. She was waking up in night two times. The outcome of the event arm pain and felt like vomiting was unknown and not recovered for other events. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1427145
Sex: M
Age:
State: IN

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/25/2021
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: caused a hard mass in his arm and he get muscle spasm; caused a hard mass in his arm and he get muscle spasm; he has shot pain; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation solution for injection,Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date in Feb2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE) for covid-19 immunisation. On an unspecified date, he had the last shot, last part of February the second shot and it caused a hard mass in his arm and he get muscle spasm or a hard shot pain and the doctor, one doctor check this, and said there was a hard mass that was causing it. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1427146
Sex: M
Age:
State:

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: Tingling on the fingertips; Pain in the Shoulder; Numbness all around his Arm; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a 12-year-old male patient that who received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via Intramuscular route of administration at Left Deltoid on an unknown date (Age at vaccination was 12-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On an unknown date patient has a few areas of painful shoulder. He has tingling in his fingertips and his arm was numb. Outcome of the events was unknown. Follow-up attempts are needed; information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427147
Sex: F
Age:
State:

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: She has got a temperature above 102 and she is feeling very high I mean, she feel high to the touch but she is cold.; She has got a temperature above 102 and she is feeling very high I mean, she feel high to the touch but she is cold.; This is a spontaneous report from a contactable consumer (grandparent). A 13-year-old female patient received second dose of BNT162B2 (Pfizer Covid 19, Solution for injection, Batch/lot number: Unknown, NDC/UPC number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 14Jun2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 15Jun2021, she had got a temperature above 102 and she was feeling very high to the touch but she was cold. Reporter stated that granddaughter got the Pfizer second dose yesterday and she got a temperature above 102 and she was feeling very high, she felt high to the touch but she was cold. Permission to probe further questions: Reporter asked whether she should take 2 Tylenol (Batch/lot number: Unknown, Expiry date: Unknown). Reporter seriousness was unspecified. Limited information available over the call. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1427148
Sex: U
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: received the 1st shot of the covid vaccine and have had an intractable migraine ever since (3weeks ago); This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as 1st dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient recently received the 1st shot of the COVID vaccine and have had an intractable migraine ever since (3 weeks ago), had to get 2 MRIs of brain and now was stuck with a 2,000 bill that patient could not afford. It was Pfizers fault because they were told it was safe and it was not. Patient would like help with paying the bill. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427149
Sex: M
Age:
State: TX

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: Running a fever; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer or other non health professional. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0217, Pfizer NTEC), via an unspecified route of administration on 14Jun2021 as 2nd dose, single for covid-19 immunization (at the age of 56-years-old). He was not having medical conditions but every now and then he takes something like for his gas. The patient's concomitant medications were not reported. The patient did not receive any other prior vaccinations. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0187, Pfizer NTEC), via an unspecified route of administration on 17May2021 as 1st dose, single for covid-19 immunization The reporter stated this was the second dose, the first dose, he did not get sick. On 15Jun2021 10:00 patient was not feeling well, nausea, patient wife took his temperature he was running a fever and so he was having like chills and muscle pain and joint pain. The reporter seriousness for the events was unspecified. It was further stated that, he took some Tylenol at work that morning, two Tylenol, he only had two dosage, he got some Tylenol at work and he haven't had any since then. The pharmacy said that continue taking Tylenol and liquids and fluids. The clinical outcome for the events was unknown.

Other Meds:

Current Illness:

ID: 1427150
Sex: F
Age:
State: FL

Vax Date: 04/04/2021
Onset Date: 04/04/2021
Rec V Date: 06/25/2021
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: I have side effects where my face has been swollen, may be one to two weeks after that; its feel swollen and it's not going down yet; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown (reported as that EW69, she doesn't know it J or 35), and Expiration Date was not reported), via intramuscularly, administered in Arm Right on 04Apr2021 (at the age of 52-year-old) as a single for COVID-19 immunization. Medical history included dialysis and blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included minoxidil, carvedilol, amlodipine, valsartan for Hypertension and ascorbic acid, biotin, cyanocobalamin, folic acid, nicotinamide, pantothenic acid, pyridoxine, riboflavin, thiamine, zinc (RENAPLEX) taken dialysis, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW7534, Expiration Date: Unknown), via intramuscularly, administered in Arm Right on 12Mar2021 as a single dose for COVID-19 immunization. On 04Apr2021, after the second shot, patient had side effects where her face has been swollen, may be one to two weeks after that and its feel swollen and it's not went down yet. Patient stated that no one had told her what was happening. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included tyrosine Serum, magnesium Serum, Micro HLB, CBC Differential Platelets, Hemoglobin A13, Hepatitis B antibody, Hepatitis C, Micro Keratin Ratio and Metabolic Panel with unknown results on an unspecified date. The outcome of event was not recovered. Additional information has been requested.

Other Meds: MINOXIDIL; CARVEDILOL; AMLODIPINE; VALSARTAN; RENAPLEX

Current Illness:

ID: 1427151
Sex: F
Age:
State: PA

Vax Date: 06/11/2021
Onset Date: 06/12/2021
Rec V Date: 06/25/2021
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: stomach ache; lethargic; dizzy; 102 fever; This is a spontaneous report from a contactable consumer(parent). This consumer (parent) reported for 12-years-old female (daughter) patient who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: ER8736) via intramuscular on 11Jun2021 at 03:15 in right arm as a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications, past drug history and known allergies were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID or any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0177) via intramuscular on 16May2021 at 12:00 in right arm for COVID-19 immunization. The patient experienced stomachache, 102 fever and she was lethargic and dizzy at 06:00 on 12Jun2021.The events were reported as non-serious. The patient did not receive any treatment. The patient underwent lab tests and procedures which included body temperature as 102 on 12Jun2021. The outcome of all events was resolved on an unspecified in Jun2021.

Other Meds:

Current Illness:

ID: 1427152
Sex: F
Age:
State:

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 06/25/2021
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: First dose: Little chemical taste; First dose: Tired; This is a spontaneous report from a contactable consumer(patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EW0167) via an unspecified route of administration, administered in Arm Left on 27May2021 15:00 (at the age of 68-year-old) and received second dose of BNT162B2 administered in Arm Left on 15Jun2021 14:00 (lot: EW0186) as single dose for covid-19 immunisation. Medical history included thyroid disorder from 1999 and ongoing. Concomitant medication(s) included latanoprost (LATANOPROST) Ongoing taken for Thyroid condition, levothyroxine sodium (TIROSINT) taken for thyroid disorder from 1999 and ongoing. On 15Jun2021 20:00 she had headache decided to take some Tylenol and it never went away, it just took the edge off. She took 500mg Tylenol and it did not work (Lot: LJA101, expiration date: Jun2021). At midnight and the whole night, she had a pressure in her head. Arm soreness, felt dehydrated, blood pressure elevated. Patient stated that she had a slight fever in the morning. Her temperature was usually 95 or 96, and if it goes a little higher, her temperature was about 98 on 16Jun2021 and experienced Heart racing and palpitations. She had a little chemical taste in her mouth for like a half hour after getting the first shot. It was strange and then passed. She was recovered completely from her symptoms after the first dose. The patient underwent lab tests and procedures which included magnetic resonance imaging: MRI no contrast on 14Jun2021.The patient had not recovered from Headache, Little fever, recovered from little chemical taste in her mouth, tired on27May2021 and outcome was unknown for remaining events. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: LATANOPROST; TIROSINT

Current Illness: Thyroid disorder

ID: 1427153
Sex: F
Age:
State:

Vax Date: 06/13/2021
Onset Date: 06/13/2021
Rec V Date: 06/25/2021
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: Worsening stuffy nose; Tiredness; Experienced coughing/Dry cough; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 12-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration to her right arm on 03Jun2021 15:00 (Batch/Lot number: EW0181, NDC number/Expiry date: Unknown) as single dose for COVID-19 immunization. Age at vaccination was 12-year-old. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 via an unspecified route of administration to her right arm on 23May2021 (at the age of 12-years) (Batch/Lot number: EW0182) as single dose for Covid-19 immunization and no reaction was reported on previous exposure to vaccine. Mother called on behalf of her daughter who took the second dose of the Pfizer COVID 19 vaccine last 13Jun2021 and experienced coughing on the same day when she took the vaccine. Tiredness on the next day but it already went away. Worsening stuffy nose and cough was persisting. Asking if these were normal side effects of the vaccine or her daughter needs to see a doctor. DSU Potential duplicate AE Report E transmit. No zip code provided. First dose was given last 30May2021. Patient would turn 13-year-old on 20Jun2021. Stuffy nose and persisting cough were not listed as side effects of the vaccine. Side effect dry cough on 13Jun2021, tiredness on 14Jun2021 and stuffy nose on 15Jun2021. Stuffy nose was reported as worsened. Her daughter had her second dose on Sunday. Her daughter was almost 13-year-old. After the vaccine she started coughing. The next day she was tired. Now she was coughing with a stuffy nose. She stated that her daughter had no fever. Referred to HCP. Caller stated it was a dry cough that started the evening of the vaccine. States it was persisting. Regarding stuffy nose, caller stated it started yesterday and was worse today. Tired, states it was only an issue for the patient the day after the vaccine. Reporter seriousness for events was unspecified. Caller denied any medications, medical conditions, labs, testing or treatments for the patient relevant to the events. Outcome of the event tired was recovered on 14Jun2021, whereas other events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1427154
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 06/25/2021
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: had both doses of the Pfizer COVID-19 vaccine in March.; Eosinophil is 670 which is 3x more; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 09Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he had both doses of the Pfizer COVID-19 vaccine in March. He said that he has testing himself for several years and his eosinophil level was always around 200 and after the vaccine, his eosinophil is 670 which is 3x more. Caller wanted to know whether the vaccine was causing this problem or there had been reports of this experience with the vaccine. The patient was suggested to consult with her physician as there was no information regarding elevated eosinophil count after being vaccinated. The outcome of the events was unknown Follow up(16Jun2021): Follow up information was received from the same contactable consumer included: non- significant information. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1427155
Sex: F
Age:
State:

Vax Date: 06/14/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: lymph node; top of her arm where she got the shot was still sore; her underarm was very painful/ pain in her underarm.; This is a spontaneous report from a contactable consumer (reported for herself). A 32-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181), via an unspecified route of administration on 14Jun2021 (at the age of 32-years-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171), first dose via an unspecified route of administration on 08May2021 (at the age of 32-years-old) for covid-19 immunisation. On an unspecified date, the patient experienced lymph node and on 15Jun2021, the patient experienced pain in her underarm and it was a very painful sharp pain, and it started hurting. The reporter stated that, she got the second vaccine on Monday, so a couple of days ago, and the top of her arm where she got the shot was still sore and also under her arm like near her armpit so opposite of where she got the shot like her underarm was very painful and it started hurting yesterday on Tuesday. reporter stated the pain was not a sore pain it was a sharp pain. The reporter wanted to know has anyone else reported this before or should she go to the doctor. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1427156
Sex: F
Age:
State: NC

Vax Date: 06/15/2021
Onset Date:
Rec V Date: 06/25/2021
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: aching; dizziness; Headache; This is a spontaneous report from a contactable pharmacist. A 86-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 15Jun2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history included vertigo. The patient's concomitant medications were not reported. On an unspecified date, patient experienced aching, dizziness and headache. As per report it was reported that, patient took the second Pfizer shot on yester-day (15Jun2021). Patient did not had a lots of symptoms that bothered her after first dose. But with the second shot, patient had aching and headache for which she took Tylenol as a relief to what she was experiencing. Then she was told that she should not take Tylenol. She said that, she did not know that. She got the fact sheet for the first one, but no fact sheet for the second shot. She was told not to take anything after she took the shot, but was told that after she took the Tylenol. It did not say anything about not taking pain medicine. She reported that, other people told her they took Tylenol. She was aching and a little dizzy. Patient took Tylenol as a treatment for events. The outcome of the events reported as unknown. Information about lot/batch number cannot be obtained. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1427157
Sex: M
Age:
State: NH

Vax Date: 06/01/2021
Onset Date: 06/10/2021
Rec V Date: 06/25/2021
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: fatigue; runny rose; coughing; sore throat; "flu like" for 6 days; phlegm in lungs; pain in body; overly sensitive; fibromyalgia; This is a spontaneous report from a contactable consumer (himself). A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 01Jun2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported first dose of confirmed Pfizer Covid 19 vaccine on 01June2021. He reported on 10Jun2021 he experienced runny rose, coughing, sore throat, "flu like" for 6 days, fatigue, phlegm in lungs, pain in body. Caller reported that these are his first flu-like symptoms in 30 years. Symptoms began on June 10th and symptoms are still current. He stated next dose: 28 June 2021. he reports that he has fibromyalgia and that he is overly sensitive, and everything is tripled in pain on unspecified date. Can I get second dose of Pfizer Covid 19 vaccine if I am still having these symptoms. On 10JUN2021, symptoms of runny nose, phlegm in the lungs, pain in the body and fatigue hit the caller. It has been 6 days and the symptoms have sort of plateaued off. The outcome of the events was reported as recovering. Information about lot/batch number is available. Follow-up attempts are needed.

Other Meds:

Current Illness:

ID: 1427158
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: out for the count this weekend; the one who administered the vaccine must have dripped or dropped some of the contents of the syringe, was reporting in case of dosage, and he suspected some of it spilled; This is a spontaneous report from a contactable consumer from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Caller stated that getting the second shot today of the Pfizer Biontech COVID-19 vaccine and reports the one who administered the vaccine must have dripped or dropped some of the contents of the syringe, was reporting in case of dosage, and he suspected some of it spilled. Caller declined to complete report on his wife at this time, says he will see if he gets sick, says lets keep that separate. Caller states his wife received the same Pfizer vaccine. The patient experienced out for the count this weekend on an unspecified date. The outcome of event was unknown. Information about batch/lot number has been requested. Further information was expected.

Other Meds:

Current Illness:

ID: 1427159
Sex: F
Age:
State: AR

Vax Date: 03/18/2021
Onset Date: 04/01/2021
Rec V Date: 06/25/2021
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: Bone spurs; Cannot sleep at night; pain that goes from her shoulder to her elbow/pain from shoulder to elbow; This is a Spontaneous case report received via Pfizer Sponsored Program from a Contactable Consumer (Patient). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: N 6199, Expiry Date: unknown), via an unspecified route of administration on 18Mar2021 administered in upper right arm as single dose for covid-19 immunisation. Medical history included heart alternation from an unknown date and unknown if ongoing. The patient takes regular (unspecified) medicines for her heart condition. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Expiry Date: unknown, Lot number: EN6201), via an unspecified route of administration on 25Feb2021 administered in upper right arm as single dose for COVID-19 immunisation. Caller stated she has had both doses of the Pfizer covid 19 vaccine. Caller stated the second dose is suspected dose for her AE. Caller stated she has a pain that goes from her shoulder to her elbow on Apr2021. It is a kind of pain that feels like her arm will fall off. She doesn't know if it's from vaccine or from other things. Pain has improved a little bit, but she can still feel it. Caller does not know if maybe there is a pinched nerve in her neck maybe it worked its way down to her arm. She just wants to rule things out. She has never had this problem before that she can remember. The patient experienced bone spurs on unspecified date, and Caller cannot sleep at night on unspecified date. Caller states her sister wanted her to call in and find out in order to rule something out. Just to make sure that the pain doesn't have anything to do with the vaccine. Pain from shoulder to elbow: Event start was in April, but she is not really sure. Pain has improved a little bit, but she can still feel it and she has a hard time sleeping at night, she switches sides back and forth. The patient underwent lab tests and procedures which included magnetic resonance imaging on neck on May2021; result: bone spurs, X-ray on May2021 result bone spurs. Therapeutic measures were taken with pain reliever and it kind of helped at first, but she can still feel it. The outcome of the event "The patient experienced bone spurs", "cannot sleep at night" was "unknown" and for event "pain that goes from her shoulder to her elbow/pain from shoulder to elbow" was "not recovered".

Other Meds:

Current Illness:

ID: 1427160
Sex: F
Age:
State:

Vax Date: 06/14/2021
Onset Date: 06/01/2021
Rec V Date: 06/25/2021
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: arm soreness; really tired; slight fever; cold/flu like symptoms; achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits; like lymph nodes are swollen; drowsy; dry mouth; doesnt feel like herself; her equilibrium off; cold/flu like symptoms; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; pain all the way up her neck and throat, shoulder and under arm pits; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 14Jun2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately on an unspecified date in Jun2021, the patient experienced arm soreness, really tired, slight fever, cold/flu like symptoms, achy/sore at night/pain all the way up her neck and throat, shoulder and under arm pits, feels like lymph nodes are swollen, drowsy, her equilibrium off, she does not feel like herself, she was in so much pain she does not feel safe to drive, and has dry mouth/cotton mouth. Clinical course of the events was reported as follows: Caller received the first dose this past Monday the 14Jun2021. She did report several adverse events. She was very shocked that she has had all of these adverse reactions after the first dose because she had been told that most people did not have an issue with the first dose. She reported she was in so much pain she does not feel safe to drive and have other people experienced these side effects. It started yesterday afternoon when it was in her system for about 24hrs. It got worsened this morning when she woke up at 6. She slept most of the morning away. She got up at 6 and got up every hour after that. She felt better after She took Tylenol and Alee, put on some cream, and was using a heating pad. The outcome of all events was unknown. No PQC involved. Information on Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1427161
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/25/2021
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: stuttering 2 weeks after receiving the second dose; or inability to understand what a person is saying; This is a spontaneous report from a contactable consumer (Patient's wife). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single for covid-19 immunization. On an unspecified date the patient experienced stuttering 2 weeks after receiving the second dose, or inability to understand what a person is saying. The patient underwent lab tests and procedures which resulted normal- all test have come back normal. The outcome of events was unknown. Follow up attempts are needed. Further information has been requested.

Other Meds:

Current Illness:

ID: 1427162
Sex: F
Age:
State: AZ

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 06/25/2021
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: pain to injection site arm; sore arm; This is a Spontaneous report from a Pfizer sponsored program. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Left arm on 15Jun2021 at 16:00 (at the age of 68-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EW0178), via an unspecified route of administration on 24May2021 administered in upper left arm as single dose for COVID-19 immunisation. The patient experience pain to injection site arm. The caller is asking if the Ibuprofen she took will interfere with the Pfizer Covid Vaccine. The CDC Committee has provided interim considerations for the use of COVID-19 mRNA vaccines (like the Pfizer-BioNTech COVID-19 Vaccine). These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate. The caller states the sore arm began 2 hours after the caller received the second dose Pfizer Covid Vaccine on 15Jun2021.The caller states she still has the sore arm. Therapeutic measures were taken with ibuprofen (Product strength and count size dispensed :200mg each tablet, count size 500, Lot: O8E2445A, Expiration: May2022, UPC: 9661962159). The outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1427163
Sex: M
Age:
State: NJ

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 06/25/2021
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: Arm soreness; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported (patient) that a 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: un EWO185) via an unspecified route of administration on 25May2021 14:48 (age at vaccination 49years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The clinical outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716077 similar report from same reporter

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm