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: 1518209
Sex: F
Age:
State: NC

Vax Date: 03/15/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
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: arm pain; escalation of Blood Pressure; increased body pain quite a bit; This is a spontaneous report from a contactable consumer, the patient. A 68-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:45 as (At the age of 68-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypersensitivity, dermatitis contact, and fibromyalgia all are from an unknown date and unknown if ongoing. Concomitant medication included propranolol; diphenhydramine hydrochloride (BENADRYL); diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN6200) via an unspecified route of administration in the left arm on 22Feb2021 at 13:30 (At the age of 67-years-old) as a single dose for COVID-19 immunisation and experienced arm pain and escalation of blood pressure, neomycin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced arm pain for 4-5 days. On an unknown date in Mar2021, the patient noticed an escalation of her blood pressure which was much worse this time and had lasted 2 weeks now, with the patient almost seeking urgent care. On an unknown date in Mar2021, the patient experienced increased body pain which was as a result of past history with fibromyalgia and the pain was much longer than a few days. Increased blood pressure was the most concerning for her. These adverse events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of high blood pressure and included treatment with more consumption of beta blocker which was advised by nurse practitioner (NP). The patient underwent lab tests and procedures which included blood pressure measurement: the escalation of my bp was much worse on has lasted over 2 weeks now on an unknown date . The clinical outcome of the events increased blood pressure, arm pain and body pain were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: PROPRANOLOL; BENADRYL; VALIUM

Current Illness:

ID: 1518210
Sex: F
Age:
State: CA

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Initial tongue swelling; Extreme muscle cramping; Terrible joint pain; Extremely exhausted; Shaking; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiry date: unknown, age at vaccination 54 years) via an unspecified route of administration on 18Mar2021 09:00 on Arm Left as dose 1, single for covid-19 immunisation administered at Pharmacy or Drug Store. The medical history includes IC Hashimoto's IBS. Allergies to food was Latex and shellfish. Concomitant medications within 2 weeks were not reported. The patient did not receive any other vaccines or medication within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID. Since the vaccination, the patient has been tested for COVID-19. On 18Mar2021 09:45 the patient reported, Initial tongue swelling. Extreme muscle cramping, she was out of rooms and extremities. Terrible joint pain as if she had room Atari arthritis. Extremely exhausted. Shaking. Been to urgent care once and taken by ambulance to ER once. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event was Benadryl tongue swelling. Muscle relaxer. Covid prior vaccination was No. Covid tested post vaccination was Yes. The patient underwent lab tests and procedures which included Nasal Swab test result negative on unspecified date. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518211
Sex: F
Age:
State: AZ

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 07/31/2021
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: low sodium blood levels; drinking tomato juice 30 minutes before the injection didn't make her feel tired.; This is a spontaneous report from a contactable consumer. The 72-year-old female consumer (patient) reported that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8732) via an unspecified route of administration into the right arm on 30Mar2021 (at the age of 72-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced low sodium blood levels and drinking tomato juice 30 minutes before the injection did not make her feel tired. She was a little tired this morning. She was having the second Covid vaccine and she has low sodium blood levels. Her doctor called her after the first Covid vaccine. Minutes after she felt so tired, she waited 15 minutes and she could not drive the car, she was exhausted. Her Husband drove. This happened on 09Mar2021 it was not until 19Mar2021 that she felt better. 10 days later and a long time. Her doctor called her into the office and they talked about her sodium level being low. It was 136 within normal level and a little above normal. It was a fine result and it was not a fasting test. She ate lunch before the test. States her sodium level may have been low at the time of the injection. She knows Campbell tomato juice 5.5 ounces has 470mg Sodium in it. It makes her more alert, like a cup of coffee. She feels when her sodium drops and when her sodium level gets better. She had a hip replacement in June and was in the hospital. Her hip was great and her Orthopedic doctor wanted to let her go but the regular doctor wanted her to stay because of her low sodium. Putting an IV does not help it. She controls it through her diet. Weight is usually between 125 and 127, she weighs 127 today. Her doctor did some research on sodium and the vaccine and could not find anything related to the sodium levels. She drank a can of tomato juice about 5 to 10 minutes before her second dose. She explained to the staff before the injection why she had to wait 30 minutes. Caller believes a pharmacy student gave her the second injection. She felt fine. Her husband had it at the same time as her and they waited after the shot together. She felt fine. She was not tired. She went home and made dinner. She was a little tired this morning and drank tomato juice and felt fine. She used to drink and knows that it has a lot of salt and it made her alert. Her doctor wanted her to try drinking tomato juice prior to getting the second dose so she did. She did not even feel anything on her arm, her arm is not red. Second dose was administered yesterday. Caller got the vaccine because she might get Covid if she did not. She does not care to go out to restaurants and she has not been to the grocery store since 07Mar2020. It was for her own health. Caller added that anything that goes through her Central Nervous System, she will have some sort of reaction, it affects her differently. She went into a surgery the medicine they gave to her went through her and affected the reaction she experienced differently. All she needs is regular Tylenol and Motrin. That's all she needs for pain. She only takes a single. Tylenol because two regular Tylenol puts her to sleep. Her husband asked if she had arm pain and she said maybe if she touched it, but she has a high pain tolerance/threshold. No history of all previous immunization with the pfizer vaccine considered as suspect, no additional vaccines administered on same date of the pfizer suspect. Her father, he did not do well, he would be hypersensitive when it came to medications, her mother was fine. Outcome was unknown for both the events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1518212
Sex: F
Age:
State: CT

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
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: soreness in left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient did not have known allergies to food, medication or other product. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, the patient experienced soreness in left arm with the first shot and it was reported that second shot resulted in much more soreness. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event soreness in left arm was not resolved at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Vaccine Facility Information added.

Other Meds:

Current Illness:

ID: 1518213
Sex: F
Age:
State: NC

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 07/31/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: very little left arm pain on the first vaccine; did notice an escalation of my Blood Pressure on day 2.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 22Feb2021 13:30 (at the age of 68 years) as single for covid-19 immunisation. Medical history included fibromyalgia and Known allergies, adhesives, multiple sensitivities from an unknown date and unknown if ongoing. Concomitant medication included propranolol taken for an unspecified indication, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. The patient previously took neomycin and experienced allergies. On 23Feb2021 09:00 the patient experienced very little left arm pain on the first vaccine and did notice an escalation of my blood pressure on day 2. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement did notice an escalation of my blood pressure on 23Feb2021 (did notice an escalation of my Blood Pressure on day 2). The adverse event was treated with more Beta Blocker. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: PROPRANOLOL; BENADRYL; VALIUM

Current Illness:

ID: 1518214
Sex: F
Age:
State: OH

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 07/31/2021
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: A lot of swelling in eyelids; Swelling in eyelids and space above eyes/under eye brows.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS734) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included loratadine (CLARITINE ALLERGY), omeprazole (MANUFACTURER UNKNOWN) and digestive probiotic (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced a lot of swelling in eyelids and space above eyes/under eye brows. When the patient woke up the next morning, it had not gone away and was still present before noon of the same day. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling in eyelids and space above eyes/under eye brows were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds: CLARITINE ALLERGY; OMEPRAZOLE

Current Illness:

ID: 1518215
Sex: F
Age:
State: NY

Vax Date: 03/31/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
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: Upper shoulder pain; Neck pain; Decreased blood pressure. Blood pressure dropped to 98/63 and then 85/54. (I'm normally 110/90); Tired; Vertigo; Headache; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration on the left arm on 31Mar2021 at 09:00, (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included vertigo. The patient had known allergies to diflucan. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) received on 02Mar2021, estradiol cipionate (ESTRADIOL), progesterone (MANUFACTURER UNKNOWN), gliclazide (CLARITIN), biotin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN) all from an unknown dates, for an unknown indications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 10 minutes after the vaccination patient experienced dizzy and headache, went to medical area at facility. On 03Apr2021 i.e. 3 days after the vaccination the patient experienced vertigo (which I had 2 years go, so I'm familiar with the symptoms), headache, dizzy, neck pain, tired, shoulder pain on right side (I get dizzy when I get up from bed or lie down, or from certain head motions. Will set tired and a headache in the afternoon. Neck/upper shoulder pain on right side) and dropped blood pressure to 98/63 and then 85/54. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events vertigo, headache, dizzy, neck pain, shoulder pain on right side, tired and dropped blood pressure was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds: ESTRADIOL; PROGESTERONE; Claritin; BIOTIN; VITAMIN D NOS

Current Illness:

ID: 1518216
Sex: F
Age:
State: OH

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 07/31/2021
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: Painful to lift left arm; Low grade fever; Fatigue; Cough; Slight chills; Chest tightness; Nausea; Arm at the injection site became very sore; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left on 22Mar2021 at 10:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications were not reported. The patient previously took Macrobid and experienced drug allergy on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 17:00, the patient experienced nausea in the evening following the vaccination and overnight the nausea worsened, arm at the injection site became very sore, developed a low-grade fever, fatigue, cough, slight chills and some chest tightness. On 23Mar2021, in the morning the patient experienced painful to lift left arm and nausea continued. By the following morning, all symptoms were gone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events nausea, arm at the injection site became very sore, low-grade fever, fatigue, cough, slight chills, some chest tightness and painful to lift left arm were recovered on 23Mar2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518217
Sex: M
Age:
State: NY

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 07/31/2021
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: 104.4 temp; chills; severe body aches; 1st 48 hours very lethargic, 48 hours later 104.4 temp, severe body aches & chills for 3 days. Tylenol does not help fever.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications was reported as N/A. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced 1st 48 hours very lethargic. On 05Apr2021, 48 hours later, the patient experienced 104.4 (unspecified units) temperature, severe body aches and chills for 3 days. The events resulted in a visit to the doctors or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the reported events and included treatment with Tylenol which did not help with the fever. The clinical outcome of the events lethargy, body aches and chills was recovering and the outcome of the event fever was not recovered at the time of report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518218
Sex: F
Age:
State: IL

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 07/31/2021
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: Neck pain; Vaginal bleeding with moderate clots; This is a spontaneous report from a contactable other hcp (Patient). A 31-years-old no pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration, administered in Arm left on 07Apr2021 at 08:30 at the age of (31-years-old) as a dose 2, single for covid-19 immunisation. Medical history of patient included none. Prior to vaccination, the patient was not affected with covid. The patient was not been tested positive for covid after post vaccination. The patient did not receive any other vaccines within four weeks of vaccination. The patient was not taken any other medications within two weeks of vaccination. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm left on 17Mar2021 at 08:30 at the age of (31-years-old) as a dose 1, single for covid-19 immunisation. It was reported that on an unspecified date in Apr2021 at 12:00 PM the patient experienced neck pain and Vaginal bleeding with moderate clots for 3 hrs and vaccination occurred at 8:30 am, moderate bleeding came suddenly at 12 pm and continue nonstop until 3pm, even spreading through her pants. Nothing like this had ever happened to her. Patient menstrual cycle is 28 days regular one, with the heavy day being the second day and never this way. This bleeding came one week prior of her next expected cycle and it only lasted for those three hours with subsequent spotting. No treatment received. The patient was recovered from the events in 2021. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518219
Sex: F
Age:
State: GA

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 07/31/2021
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: Rash not at injection site; Facial swelling; Lip swelling; Fatigue; joint pain; Muscle aches; Headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Epb955) via an unspecified route of administration in the left arm on 07Apr2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included polymorphic light eruption, deaf in left ear since birth, vitreous gel detachment, epiretinal membrane, polycystic ovarian syndrome, COVID-19 on unknown dates, latex allergy, caffeine allergy (coffee), allergy to plants (chamomile and cilantro), vegetable allergy (cucumbers and rutabaga), spice allergy (cumin) and allergy to wasp stings (wasps). The patient received unspecified medications within two weeks of vaccination for unknown indications on unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 15:30, the patient experienced rash not at injection site, facial and lip swelling, fatigue, joint pain, muscle ache and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events rash not at injection site, facial and lip swelling, fatigue, joint pain, muscle ache and headache were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518220
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 07/31/2021
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: Metallic taste in mouth 5 min post injection. Duration of about 5 minutes.; Feeling slightly dizzy 5 min post injection. Duration of approximately 5 min.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 07Apr2021(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Apr2021, within 5 minutes of receiving the vaccine the patient experienced metallic taste in mouth and felt slight dizzy for a duration of about 5 minutes. The metallic taste feeling was similar to what was experienced before vomiting, but without nausea. The clinical outcome of the event metallic taste and dizzy was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518221
Sex: F
Age:
State:

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 07/31/2021
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: Burning uterine pain; Burning uterine pain; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 12:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:45, the patient experienced burning uterine pain. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event burning uterine pain was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518222
Sex: F
Age:
State: NY

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/31/2021
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: migraine; vomiting; fever; chills; fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 15:00, the patient experienced migraine, vomiting, fever, chills, fatigue and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events migraine vomiting, fever, chills, fatigue and joint pain was recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1518223
Sex: M
Age:
State:

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 07/31/2021
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: Arm/shoulder pain; Arm/shoulder pain; Swelling at injection site; Numbness/tingling sensation radiating down arm; Numbness/tingling sensation radiating down arm; Mild headache; Nausea; Body aches; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021 at 20:00, the patient experienced arm/shoulder pain and swelling at injection site. Numbness/tingling sensation radiating down arm. Additionally, mild headache, nausea, body aches, chills and no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events arm/shoulder pain and swelling at injection site, numbness/tingling sensation radiating down arm, mild headache, nausea, body aches, chills and no fever were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1518224
Sex: F
Age:
State: KS

Vax Date: 04/05/2021
Onset Date: 04/08/2021
Rec V Date: 07/31/2021
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: No voice; Really sick; Fever; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on 05Apr2021 at 16:00 (at the age of 41-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included asthma and hypothyroidism and COVID-19 on 31Oct2020 and unknown if ongoing. Patient received unspecified medications (concomitant medications) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (unknow result). It was reported that after receiving the dose of vaccine she was really sick with fever and sore throat on day 1 and 2 (on 08Apr2021 at 23:00). Day 3 sore throat was worse and woke up day 4 (on 09Apr2021) and had no voice. It was unknown if the patient received any treatment. On 31Oct2020, the patient underwent lab tests and procedures which included PCR Covid test (nasal swab) which was positive on 31Oct2020. The reporter assessed the events as non-serious. The outcome of the events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518225
Sex: M
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 07/31/2021
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: Pain in right ear; Swollen gums in lower right quadrant of mouth; Extreme pain in jaw; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 01Apr2021 at 09:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not included. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 08:00, the patient experienced pain in right ear, swollen gums in lower right quadrant of mouth and extreme pain in jaw (ruled out as dental issue). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with antibiotics prophylactically. The clinical outcome of pain in right ear, swollen gums in lower right quadrant of mouth and extreme pain in jaw was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518226
Sex: F
Age:
State: OK

Vax Date: 03/03/2021
Onset Date: 03/04/2021
Rec V Date: 07/31/2021
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 had a rash with itching; she had a rash with itching; a lump, swelling, that lasted for about 4 to 5 days; a lump, swelling, that lasted for about 4 to 5 days; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 11:15 as DOSE 1 (age at vaccination:74 years), SINGLE for covid-19 immunisation (Reason for no lot number: of Pfizer covid vaccine: Other: Provides lot number as EN62 OC or OR for the first vaccine. She is unsure because it is handwritten). Medical history included ongoing rheumatoid arthritis (Diagnosed 10 years ago, ongoing malignant melanoma (Diagnosed about 6 years ago. It is the most serious form of skin cancer), covid-19 from Jan2021 to an unknown date First week of January. Concomitant medications included levothyroxine sodium (SYNTHROID) (She has been taking it for 30 years. Took one the morning of the vaccination) and escitalopram oxalate (LEXAPRO) (Started taking this 20 years ago). The patient experienced she had a rash with itching, a lump, swelling, that lasted for about 4 to 5 days on 04Mar2021. The day after the first vaccine she had a rash with itching and a lump, swelling, that lasted for about 4 to 5 days, she recovered completely on an unknown date in Mar2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: SYNTHROID; LEXAPRO

Current Illness: Melanoma (Diagnosed about 6 years ago. It is the most serious form of skin cancer.); Rheumatoid arthritis (Diagnosed 10 years ago.)

ID: 1518227
Sex: F
Age:
State: OH

Vax Date: 03/20/2021
Onset Date: 03/21/2021
Rec V Date: 07/31/2021
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: I had heart palpitations a couple a night.; heart palpations was reported as worsened; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 37-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8727, patient was 37-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 20Mar2021 at 10:30 as single dose for covid-19 immunisation. There were no medical history and concomitant medications reported. It was reported that patient wants to know are there any reports about the vaccine giving people heart palpitations. she has had heart palpitations and before when she would get sick, she would have one every once in a while. Caller states she had them a couple a night for the first week. Caller states then they got worse this week after the vaccination. I went to my doctors and had a physical. All my blood work, everything is fine. My doctor didn't say anything about it and told me to get the 2nd dose. She said nothing can happen to your heart if you have a normal and healthy heart. Reported that patient got the Pfizer vaccine on 20Mar2021, no 30Mar2021, she's due for her second one on the 20Apr2021. No blood pressure issues, good cholesterol, she's healthy. Caller states the heart palpitations are every night, about two times a night, and she thought she was overlooking, and thought it was a side effect, but they are more frequent now than it was before. Stated it is like four times now or more. Caller states they are happening during the daytime too. No history of previous immunizations with the Pfizer vaccine considered as suspect. No additional Vaccines administered on same date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 21Mar2021, the patient experienced i had heart palpitations a couple a night, heart palpations was reported as worsened. It was reported that reporter seriousness for heart palpations was Unspecified. No AE(s) require a visit to emergency room and physician office. The patient underwent lab tests and procedures which included blood test resulted as normal on 12Apr2021. The outcomes of events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518228
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: muscular discomfort; a nodule with multiple nodules appeared in the thyroid isthmus; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose, dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included covid-19 from Jul2020 lymphadenopathy, phlebitis. The patient's concomitant medications were not reported. The patient experienced muscular discomfort, a nodule with multiple nodules appeared in the thyroid isthmus on an unspecified date with outcome of unknown. Follow-up (19Apr2021): This follow-up report is for reporter mother. No new safety information is provided in the F/U source document. During conversation for INT00208789 she reported that her mother had the same AE after her second dose of Pfizer-BioNTech COVID-19 Vaccine. Thyroid nodules. Her mother is 72 and had lung cancer. No more information was provided. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Proposed response: In clinical studies, adverse reactions in participants 16 years of age and older included lymphadenopathy (0.3%). Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Published safety and final efficacy results from the Phase 2/3 part of the ongoing, placebo-controlled, pivotal study reported a total of 64 vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported an event of lymphadenopathy. This included 26 male participants (0.3%) and 38 female participants (0.4%). In cases where location was specified, AEs of lymphadenopathy occurred in the arm and neck region (in axillary, left axillary, left para clavicular, left supra clavicular, bilateral cervical, or unspecified lymph nodes). Most lymphadenopathy events were reported within 2 to 4 days after vaccination (15 events were reported =8 days after vaccination, including 1 event reported 98 days after). The average duration of these events was approximately 10 days, with 11 events ongoing at the time of the data cutoff.

Other Meds:

Current Illness:

ID: 1518229
Sex: F
Age:
State: NY

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
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: nosebleed for 4.5 hours; blood pressure was 218/170; left side ear also split on the outside and bled the next day; left side ear also split on the outside and bled the next day; This is a spontaneous report from a contactable consumer (the patient). This 41-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 05Mar2021 19:15 (at the age of 41-year-old) as single dose for COVID-19 immunization. Medical history included nasal polyps and high blood pressure. Concomitant medications included losartan (manufacturer unknown), loratadine (CLARITINE), mometasone furoate (FLONASE), amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL) and ibuprofen (ADVIL); all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 20:00, the patient experienced "nosebleed for 4.5 hours" requiring an emergency room visit and treatment of 'Rhino Rocket' (nasal packing kit). On 07Mar2021, her "blood pressure was 218/170". On an unspecified date in Mar2021, her "left side ear also split on the outside and bled the next day". The clinical course was described as follows: "my nosebleed was so bad that I had to go in an ambulance to the hospital. My blood pressure was 218/170. All bloodwork was good, platelets/hemoglobins/etc. My nose bled for 4.5 hours. I had to get a 'Rhino Rocket' to stop the bleeding. I have never had a bloody nose like this before. I do have nasal polyps. A nurse I work with, who also has nasal polyps, had the same thing happen after her second dose. This happened to me 48 hours, to the hour, after my first dose. It was my left nostril and I had the first dose in my left arm. My left side ear also split on the outside and bled the next day. There was no cut. I did second dose, 31Mar2021, in right arm and had no reactions. I have had no issues since. I am a huge advocate of your vaccine." The clinical outcome of the events "nosebleed for 4.5 hours", "blood pressure was 218/170", and "left side ear also split on the outside and bled the next day" was resolved in Mar2021.

Other Meds: LOSARTAN; CLARITINE; FLONASE [MOMETASONE FUROATE]; ADDERALL; ADVIL [IBUPROFEN]

Current Illness:

ID: 1518230
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 07/31/2021
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: Her heart was racing for 3 hours in the middle of the night.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Apr2021, the patient experienced her heart was racing for 3 hours in the middle of the night. Patient stated she received the first shot on Thursday, 01Apr2021. Then on 02Apr2021 and 03Apr2021 her heart was racing for 3 hours in the middle of the night. She had this again on Sunday and Wednesday. This was early in the morning at like 5:00 in the morning. She had 2 events Sunday going into Monday. She went to see her GP but he said she needed to see a cardiologist. She had to go to the ER that Wednesday night but it was gone by the time she got there. That was the last event. It has not happened since then. She stated she has to assume it was from the shot. She exercises every morning, has never had any heart problems and has low blood pressure so this is out of character and thinks it is linked to the vaccine. She has a history of a pretty robust immune system. She stated she had a heart monitor and nothing happened. She was supposed to take the second dose on 22Apr2021 but delayed it and would prefer to wait to get more testing done before she gets the second dose. She stated she could probably get it past the 42 days if she needed to. She stated she wanted to take it but does not want to have a heart attack. She stated she knows we are collecting safety data and we have to have some information. She stated she knows she was not the only one reporting cardiac symptoms. She stated there is an article of heart muscle inflammation after the Pfizer Covid vaccine. She asked for more information on these types of symptoms and reports of it. She asked how long would it take until an antibody test would show up positive so she can see if she is protected after one dose? CDC stated that antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. The adverse event resulted in emergency room visit. The outcome of the event was reported as recovered on unspecified date in Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518231
Sex: U
Age:
State: VT

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: heart palpitations; shortness of breath; headaches; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer sponsored program regulatory authority. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that it has been over two weeks since his/her second dose of the Covid 19 vaccination and from an unspecified date he/she continued to have heart palpitations, headaches and fatigue as well as shortness of breath. Patient was concerned that these side effects are lasting so long and wanted advise. The outcome of all the events was not recovered. No follow-up attempts are needed. information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518232
Sex: F
Age:
State: MA

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 07/31/2021
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: terrible taste/some odd taste on her mouth (salty like)/mouth taste really strange/bad taste in my mouth; also aching in her tooth and tingling on her lips; also aching in her tooth and tingling on her lips; This is a spontaneous report from a contactable retired nurse (patient). A 71-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8732; Expiration Date: 31Jul2021, NDC and UPC number was unknown), via an unspecified route of administration on 31Mar2021 as dose 2, single (at the age of 71-years-old) for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included tamoxifene citrate taken for cancer, start and stop date were not reported. Historical vaccine included patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6206 and Expiration Date: 30Jul2021, NDC and UPC number was unknown), via an unspecified route of administration on 10Mar2021, as dose 1, single (at the age of 71-years-old) for covid-19 immunisation. Patient stated she saw on the news a couple days before she received the second dose that people had been complaining of their mouth being full of metal and nickel after the vaccine. On 31Mar2021, since her vaccination, patient had terrible taste, odd taste in her mouth (salty like), really bad taste in my mouth, mouth taste really strange, her lips kind of like salty all the time and also had aching in her tooth and tingling on her lips. Patient had no idea what to do, she gone to infectious disease doctor, she had no idea no idea, she mentioned that she had just gotten her vaccine, doctor said well it might be but you knows nobody knows we were in pandemic. Patient stated that she also had an endoscopy this past Wednesday (28Apr2021) at the hospital. Patient stated that odd taste in her mouth was still persisting today (04May2021), and she doesn't know when it will go away. Causality reported by the patient, patient stated that it must be, it had to be, because nothing else in her life had changed, and when she got the second dose then she had this odd taste in her mouth, that she thought it will go away and it had not yet. Patient would like to know if these side effects had been reported before, like to know if her side effects were caused by the vaccine how long will it last. Patient stated that it was not fun to eat anymore due to the taste in her mouth and was concerned about an odd taste in her mouth. The outcome of terrible taste/some odd taste on her mouth (salty like)/mouth taste really strange/bad taste in my mouth was not recovered and unknown for rest of the events. No follow-up attempts are needed. No further information is expected.

Other Meds: TAMOXIFENE CITRATE

Current Illness:

ID: 1518233
Sex: F
Age:
State: MN

Vax Date: 04/03/2021
Onset Date:
Rec V Date: 07/31/2021
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: Underneath my ear and in front of my ear like a gland swollen; Huge lump in front of ear goes from middle of ear down to jaw where bottom of gland have pain; Huge lump in front of ear goes from middle of ear down to jaw where bottom of gland have pain; Pain in cheek; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8729), dose 1 via an unspecified route of administration on 03Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included omeprazole (PRILOSEC). It was Reported, consumer stated, got my first vaccine on (03Apr2021) and after my first vaccine I had my, underneath my ear and in front of my ear, had like a gland that was swollen, so she thought like and it is said that you know that it's like normal that your gland swell. Gone for my second vaccine today actually had to leave right now had to drove for three hours and also had pain again and it's like a huge lump in front of my ear goes from the middle of my ear down to my jaw and where my jaw is like where your gland at the bottom of jaw there that's where the pain. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected

Other Meds: PRILOSEC

Current Illness:

ID: 1518234
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: Uncontrollable blood sugar for several weeks since getting initial shot.; This is a spontaneous report from a contactable consumer or other non hcp. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: Unknown) at the age of 24 years, as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Juvenile Diabetes (Type I). It was unknown if the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It was reported that the patient experienced uncontrollable blood sugar for several weeks since getting initial shot, on an unspecified date. The event was reported as non-serious. No treatment was received for the event. The clinical outcome of the event was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1518235
Sex: F
Age:
State: MA

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 07/31/2021
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: numbness in left hand; numbness/tingling in face; numbness/tingling in face; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0173) via an unspecified route of administration in the left arm on 01May2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the left arm on 09Apr2021 at 17:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 10:15, the patient experienced numbness in left hand immediately after shot and numbness/tingling in face for 1 hour after shot. The clinical outcome of the event numbness in left hand was resolved on an unknown date in May2021; while that of numbness/tingling in face was resolved on 01May2021 at 11:15, after the duration of 1 hour. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518236
Sex: F
Age:
State: CA

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 07/31/2021
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: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy. On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.

Other Meds: ARMOUR THYROID; LYRICA; CONCERTA; LINZESS; METFORMIN

Current Illness:

ID: 1518237
Sex: M
Age:
State: MA

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 07/31/2021
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: Had major allergic response; Symptoms of runny nose; Symptoms of runny nose, congestion; Hacking cough that affected sleep for two days; Hacking cough that affected sleep for two days; Breathing difficulties; This is a spontaneous report from a contactable consumer (patient). This 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder and seasonal allergies, both from unknown dates and unknown if ongoing. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL ER), and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL SHORT-ACTING), both from unknown dates for unknown indications. The patient had no know allergies, was not diagnosed with COVID-19 prior to vaccination, and the patient had not received any other vaccines within 4 weeks. On 18Apr2021 the patient experienced a major allergic response starting 5 hours after vaccination with symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties that sent him to the emergency room 48 hours later. The patient required a physician office visit and emergency room visit for the events. The patient was treated with a nebulizer, oxygen, steroids, and albuterol inhaler. The clinical outcomes of major allergic response, symptoms of runny nose, congestion, hacking cough that affected sleep for two days and resulted in breathing difficulties were recovering. Since vaccination the patient had been tested for COVID-19 via nasal swab on 20Apr2021 and 26Apr2021, both indicated negative.

Other Meds: Adderall ER; Adderall short-acting

Current Illness:

ID: 1518238
Sex: F
Age:
State:

Vax Date: 04/24/2021
Onset Date: 04/27/2021
Rec V Date: 07/31/2021
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: Exhausted; Heart was racing so bad, it was ridiculous; heart was racing terrible; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself. A 63-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW01770, Expiration date: unknown), via intramuscular, administered in left arm on 24Apr2021 (at the age of 63-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in left arm on as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history includes thyroid disorder and concomitant medications include levothyroxine. On 27Apr2021, 3 days after the vaccination, the patient experienced heart racing so bad, it was ridiculous, and she knew it does like afterwards that heart could be raising but she had no idea that is the only thing that she could attribute. She was there in the bed and her heart was racing terrible. In the next morning she woke up she was exhausted. Consumer said she wanted to report because there was no other reason for heart would be racing like that, so she just thought it had to be a side effect from Pfizer and she never had this before. The events assessed as non-serious. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1518239
Sex: F
Age:
State: CA

Vax Date: 04/28/2021
Onset Date: 05/01/2021
Rec V Date: 07/31/2021
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: extreme nerve pain in lower spine/back while sitting.; left leg became extremely weak and could not lift it; spinal nerve compression; This is a spontaneous report from a non-contactable consumer (patient). This 56-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8735) via an unspecified route of administration on 28Apr2021 at 10:00 (at the age of 56-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included autoimmune disorder, chronic kidney disease stage 2 (CKD2), anemia, peanut allergy, and shellfish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number ER8734) on 05Apr2021 as a single dose for COVID-19 immunization. The patient previously received penicillin and prochlorperazine (COMPAZINE) from unknown dates for unknown indications and experienced allergy. On the third day after the shot (01May2021) at 07:00 the patient experienced extreme nerve pain in lower spine/back while sitting. It got worse over several days and the left leg became extremely weak. She could not lift it. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited urgent care as a result of the events and was diagnosed with spinal nerve compression of unknown cause. The patient received treatment with an anti-inflammatory shot, prednisone, and pain reliever. The outcome of spinal nerve compression of unknown cause was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1518240
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: her sister received the pfizer covid-19 vaccine and began to experience palpitations; This is a spontaneous report from a contactable Other Health Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported her sister received the pfizer covid-19 vaccine and began to experience palpitations on an unspecified date. She declined to provide her sister's name and contact information. The outcome of event was outcome. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518241
Sex: F
Age:
State: NY

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 07/31/2021
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: Bad body aches, particularly bottoms of feet; Bad body aches, particularly bottoms of feet; This is a spontaneous report from a contactable consumer. A female patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in 2021, the patient had very bad body aches, particularly the bottoms of feet for 2 days. The clinical outcome of the events bad body aches, particularly bottoms of feet were resolved on an unspecified date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518242
Sex: F
Age:
State: CA

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 07/31/2021
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: brown and red discharge; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04May2021(at the age of 32-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient previously took first dose of Covid-19 Vaccine(Covid-19 vaccine-Manufacturer Unknown: Lot number-unknown) as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 21:00 the patient experienced brown and red discharge. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event brown and red discharge was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518243
Sex: F
Age:
State: VA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 07/31/2021
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: Palpitation/Little bit of heart palpitations; Chest pain and pressure that lasted for a day; Chest pain and pressure that lasted for a day/Chest pressure; This is a spontaneous report received from a contactable consumer (Patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0158), Solution for injection, via an unspecified route of administration, administered in Arm Left on 15Apr2021 (at the age of 51-year-old) as single dose for covid-19 immunisation. Medical history was reported as none. Family history was reported as none. The patient's concomitant medications were not reported. Patient did not receive any vaccine within four weeks prior to receiving Pfizer vaccine. Patient did not administer any additional Vaccines on Same Date of the Pfizer Suspect. On 16Apr2021, the patient experienced palpitation/little bit of heart palpitations, chest pain and pressure that lasted for a day. 51-year-old female stated that one day after receiving the first dose of the Pfizer Covid-19 vaccine on 15Apr2021 she experienced palpitation, chest pain and pressure that lasted for a day. She read an article that there were reports of heart enlargement after taking the second dose. Stated that after the first dose of the vaccine she was having a little bit of heart palpitations and chest pain. It went away the next day. She did not know if this was related to the vaccine. She stated that more than palpitations it was a chest pressure feeling. The symptoms began the morning after her first dose of the vaccine. They were gone the day following that. She waited 15 minutes at the vaccination site after the vaccine to see if she had a reaction. She wasn't really expecting anything related to the vaccine to happen the day after the vaccine. Her second dose was scheduled for this Monday, 10May2021. The events were recovered on 17Apr2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518244
Sex: F
Age:
State: MN

Vax Date: 04/29/2021
Onset Date: 04/30/2021
Rec V Date: 07/31/2021
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: The following morn I woke up with pain in my hips and legs. Lasted all day.; The following morn I woke up with pain in my hips and legs. Lasted all day.; By after dinner I was freezing, nauseous and weak.; By after dinner I was freezing, nauseous and weak.; By after dinner I was freezing, nauseous and weak. The next 2 days I was very weak.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 12:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy. The patients past drug was reported as no. Concomitant medications taken within two weeks prior to vaccination included Multi vitamin (unspecified), allergy pill (unspecified), vitamin d nos (VITAMIN D) and calcium (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following morning, on 30Apr2021 at 07:00, the patient woke up with pain in hips and legs. Lasted all day. By after dinner she was freezing, nauseous and weak. The next two days the patient was very weak. On the day of report, 04May2021, was the first day she felt fine since getting the shot. The clinical outcome of the event woke up with pain in hips and legs, by dinner was freezing, nauseous and weak was resolved on 04May2021. No follow-up attempts are needed. No further information is expected.

Other Meds: Vitamin d; CALCIUM

Current Illness:

ID: 1518245
Sex: F
Age:
State: TX

Vax Date: 05/05/2021
Onset Date: 05/09/2021
Rec V Date: 07/31/2021
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: Patient was symptomatic tested positive for Covid-19 on 7/25 via Rapid Antigen Test; Patient was symptomatic tested positive for Covid-19 on 7/25 via Rapid Antigen Test; persistent dry mouth; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, administered in Arm Left on 14Apr2021 10:00 (at the age of 46yeas old, Lot Number: ER8730),and the second dose administered in Arm Left on 05May2021 10:00 (at the age of 46yeas old, Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included Elevated prolactin. The patient was not pregnant.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa drugs and codeine and experienced Allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination the patient was not diagnosed with COVID-19.The patient experienced persistent dry mouth on 09May2021 (21:00). She was not admitted to hospital and did not receive any treatment. As of 25Jul2021,it was reported that patient was symptomatic tested positive for Covid-19 on 25Jul2021(23:30) via Rapid Antigen Test. She received steroids, azithromycin as treatment due to it.Hospitalization Prolonged: No.It resulted in Doctor or other healthcare professional office/clinic visit.Since the vaccination, she has been tested for COVID-19, covid test type post vaccination=Nasal Swab,and Negative on 26Jun2021, Positive on 25Jul2021. The outcome of the events was resolving.

Other Meds: ZYRTEC ALLERGY

Current Illness:

ID: 1518246
Sex: M
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: Got Covid after having the vaccine; Got Covid after having the vaccine; The initial case was missing the following minimum criteria: suspect product is not reported or specified. Upon receipt of follow-up information on 22Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient's friend). An 84-year-old male age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EN6200), via an unspecified route of administration on an unspecified date (at the age of 84-years-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test and results unknown. On an unspecified date it was reported as the 84-year-old patient got COVID after having the vaccine. Reporter stated that the patient was tested for COVID the following week after the vaccine was administered. He was home for about 1 month and he was glad. Then After 1 month he went and got antibodies, they injected him with the antibody infusion as outpatient in unknown hospital. He was waiting to get the second dose of vaccine. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1518247
Sex: F
Age:
State: SC

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 07/31/2021
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: Hard time breathing; At night is up coughing; Fatigue/ tired and stayed in bed all day; Chills; Low grade fever; Something cuts off in her chest and neck area; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 51-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0169 and expiration date: Aug2021), via an unspecified route of administration in arm left on 29Apr2021 at 12:30 (at the age of 51-years-old) as dose 2, single for COVID-19 immunisation. Medical history included that she had bipolar for at least 20 years, and she has been in remission for the last 6, She has had the peripheral neuropathy for 15 or 20 years at least, She had surgery, a right knee replacement, and she got the first dose before she went in for surgery in the hospital on 09Apr2021. In the hospital they gave her 2 different antibiotics. She doesn't know if that has anything to do with it or not. She had the antibiotics on 09Apr2021 when she had her knee replaced. She doesn't know the antibiotics they gave her. She verifies her knee replacement was on 09Apr2021. Her dad had cancer and her moms dad had diabetes. That, scoliosis, and stroke are all that runs in her family. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8727 and expiration date: Jul2021), via an unspecified route of administration in arm left on 25Mar2021 at 08:30 as dose 1, single for COVID-19 immunisation. Patient did not receive any other vaccine on the same day of Pfizer vaccine. The patient's concomitant medications were not reported. The patient on the night she got the second dose of the vaccine she went straight to bed. She had chills and everything and went to bed. The first night a bunch of her symptoms went away but the others remained. She had chills on 29Apr2021. She also had a low grade fever on 29Apr2021 that went away the next day 30Apr2021. The chills went away the next day on 30Apr2021. Sometimes she was cold and sometimes she was hot. She was in menopause so she can't say if she has recovered or if these are due to it. She was tired and stayed in bed. She has recovered completely from the low grade fever. She stated something cuts off in her chest and neck area. On 01May2021, she has had a hard time breathing the first or second day after the shot and at night she was up coughing. What happens when she lays down she loses her breath. She spent the first 2 days in bed. She coughs and then can't breathe at all. She has fatigue as well and she was in bed for 2 days because of the fatigue and stuff. She has an appointment with her physician next week. She wanted to report this anyway in case. She doesn't know the number for her physician's address, but it is on University Drive. She does not have an email available for her physician. All of these symptoms were still going on now. Her trouble breathing was mostly at night and can happen a couple times during the day when she lies down. She doesn't sleep laying down all the way, she was up a little bit. It starts with a cough and then she was not able to breathe. It is like something catches her breath. The first dose was in an old police building and where she got the second dose used to be a call centre in a big building. The adverse event did not require to visit Emergency Room or Physician Office. No prior Vaccinations (within 4 weeks). Patient was not hospitalized. No AE following prior vaccinations. On 30Apr2021, outcome of the events chills and low grade fever was recovered. The outcome of the events something cuts off in her chest and neck area was unknown while the outcome of hard time breathing, fatigue and at night is up coughing was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518248
Sex: U
Age:
State:

Vax Date: 05/04/2021
Onset Date: 05/06/2021
Rec V Date: 07/31/2021
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: Having really intense heart palpitations yesterday and today; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, Expiry Date: unknown, NDC number: unknown) via an unspecified route of administration on 04May2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 on an unspecified date at dose 1, single for covid-19 immunisation. On 06May2021 the patient experienced having really intense heart palpitations yesterday and today. Reporter stated, reporter had second shot on Tuesday reporter not sure if this is the right extension but reporter having really intense heart palpitations yesterday and today. And reporter just wondering if that's the normal side effect. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518249
Sex: F
Age:
State: AZ

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 07/31/2021
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: Exactly after 2 hours after receiving the shot I became very dizzy and my body tingled. The dizziness was the most concerning because I knew I would fall if I got up. I was sitting down eating lunch; Exactly after 2 hours after receiving the shot I became very dizzy and my body tingled. The dizziness was the most concerning because I knew I would fall if I got up. I was sitting down eating lunch; The nausea came a little later and has stayed with me; feltsplotchy; States she felt herblood pressure lowering; she wouldn't have strength to stand up; She felt very weak; had a mildheadache; splotchy visIon; This is a spontaneous report from a contactable other HCP, the patient. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8736) via intramuscular in left Arm on 09May2021 12:15 as DOSE 1, SINGLE (age at time of vaccination 54 years) for COVID-19 immunization. Medical history included migraines and mild arthritis. The patient had allergy to Sulfa. Concomitant medications included Betamethasone Dipropionate capsules (DIMETASONE) to level out hormone 20mg once to twice a day (taking this for years), Cetirizine Hydrochloride (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE], Zinc chloride and Multivitamin and Vitamin D. The patient previously received heptavax vaccine. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 (exactly after 2 hours after receiving the shot), the patient became very dizzy, and her body tingled. The dizziness was the most concerning because she knew she would fall if got up. The nausea came a little later, the severe dizziness was off and on for about an hour and a half, was lightheaded, had splotchy vision, felt her blood pressure lowering and not doing well, could not stand up, did not have the strength, mild headache and arms and legs tingled. The patient relevant test was none. The outcome of (Felt very weak, Nauseated and Arms and legs tingled, felt very weak) was recovered completely in 2021 and (paresthesia and dizzy) was recovering and (felt splotchy, Hypotension, headache and splotchy vision) was unknown. Additional information has been requested and will be provided as it becomes available.

Other Meds: DIMETASONE; EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]; ZINC CHLORIDE; VITAMIN D [COLECALCIFEROL]

Current Illness: Allergy; Arthritis; Migraine

ID: 1518250
Sex: F
Age:
State: PA

Vax Date: 04/11/2021
Onset Date: 04/01/2021
Rec V Date: 07/31/2021
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: stated she notices some purple dots on her face and then knows that the rash is imminent,/ I had a rash in the back of my neck and on my face; it seem like it was from the head on the top of forehead; Itching; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533, age at vaccination: 72-years-old) via an unspecified route of administration on left side on 11Apr2021 as dose 2, single for COVID-19 immunization; tocopheryl acetate (EVION [TOCOPHERYL ACETATE], formulation cream), route of administration, start and stop date, batch/lot number and dose were not reported taken for an unspecified indication. Medical history included insulin-dependent diabetes and high blood pressure. Concomitant medications included insulin detemir (LEVEMIR) taken for diabetes mellitus; insulin aspart (NOVOLOG); atenolol (ATENOLOL); spironolactone (SPIRONOLACTONE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); amlodipine besilate (NORVASC); atorvastatin (LIPITOR [ATORVASTATIN]); olmesartan medoxomil (BENICAR) taken for hypertension. Previously, patient received first dose of bnt162b2 (Lot number EN6208, age at vaccination: 72-years-old), in left arm on 21Mar2021 for COVID-19 immunization and experienced a little hive on her hip, on the left side, the same side she received the needle and small rash on head yet same side on the arm that it was given on left side. On an unknown date in Apr2021, a couple of days later, the patient noticed some purple dots on her face and then knew that the rash was imminent, it came on the area of the purple dot, which was uncomfortable and concerning, and had a rash in the back of her neck and on face, it seemed like it was from the head on the top of forehead. Patient reported that the rash may got on face on both sides right and the left and the odd thing was when she brokeup in those rashes she got like a purple dark, when she saw the purple dark on her face, she knew that the rash was coming, that's why she was scared about it. She already called her doctor and he told her it seemed to be one of the side effects from the vaccine. On an unspecified date in Apr2021, the patient also experienced itching. But yesterday (14May2021), it was over a month that she received the shot and what occurred was the rash had reappeared and it was still there. On an unknown date in May2021, the patient underwent laboratory test which included urine test and many blood works at her doctor's office, result was unknown. For corrective therapy, patient did try putting some Evion cream on it, but that really did not help and made it worse, had Benadryl tablet 5mg by mouth, Xyzal tablet 5mg by mouth, and she took Xyzal last night (14May2021) as she thought that would help with her itching. She wanted to know if any information about how long these rashes will go and what she could use on it. The outcome of event itching was unknown while for the other event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: LEVEMIR; NOVOLOG; ATENOLOL; SPIRONOLACTONE; ASPIRIN [ACETYLSALICYLIC ACID]; NORVASC; LIPITOR [ATORVASTATIN]; BENICAR

Current Illness:

ID: 1518251
Sex: U
Age:
State:

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 07/31/2021
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: Fever; Chills; Nauseated; Diarrhea; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07May2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 07May2021 the patient experienced fever, chills, nauseated, diarrhea. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518252
Sex: M
Age:
State: VA

Vax Date: 05/12/2021
Onset Date: 05/13/2021
Rec V Date: 07/31/2021
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: Itching/Rash and itching moved up legs, onto stomach and back.; Rash/Rash and itching moved up legs, onto stomach and back.; feet and hands red and swollen; feet and hands red; Throat tightness; Swallowing felt tight; This is a spontaneous report from a contactable other healthcare professional reporting for himself. A 46-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 12May2021 (Batch/Lot Number: EW0168) as single dose (at age of 46-years old) for covid-19 immunization. The patient concomitant medications were not reported. Patient previously took first dose of BNT162B2 (lot Number EW0153) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as single dose for covid immunization. No other vaccine in four weeks, and no other Medications in two weeks. Patient was not diagnosed COVID prior to vaccination. No covid tested post vaccination. Known allergies reported none known. Other medical History was none. On 13May2021, the patient experienced less than 24 hours post 2nd shot, feet and hands red and swollen and itching. Rash and itching moved up legs, onto stomach and back. Throat tightness and swallowing felt tight. Continued for several days and had to seek medical treatment with steroids and hydroxyzine. Therapeutic measures were taken as a result of all events. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was recovering. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1518253
Sex: M
Age:
State: TX

Vax Date: 05/06/2021
Onset Date:
Rec V Date: 07/31/2021
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: Feeling lightheadedness and High Blood Pressure even after 10 days of 2nd dose; Feeling lightheadedness and High Blood Pressure even after 10 days of 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 06May2021 08:30 (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 15Apr2021 08:30 (at the age of 36-year-old) as dose 1, single for covid-19 immunisation and experienced hypertension. On an unspecified date in 2021, the patient experienced feeling lightheadedness and high blood pressure even after 10 days of 2nd dose. The patient underwent lab tests and procedures which included blood pressure measurement: 140/94 on 17May2021; Today my BP is around 140/94. The outcome of the events were not recovered. Device Date : 17May2021 Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1518254
Sex: F
Age:
State: TX

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 07/31/2021
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: second dose: really high fevers; She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 001C21A), via an unspecified route of administration on 21Apr2021 as dose 2, single for COVID-19 immunization. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA 1273), Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included COVID-19 from on an unspecified date in Nov2020 to an unknown date (patient got the COVID virus from her brother in Nov2020). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 046A21A), via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced second dose: really high fevers on 21Apr2021, She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable on an unspecified date in 2021. Reporter is calling about the COVID 19 vaccine. She calling on behalf of her brother. While patient is reporting on her brother's experience with the Pfizer COVID 19 vaccine, caller states, it maybe be helpful. She had the COVID vaccine as well but she had Moderna so she does not know if it is comparable but she was she was sick, only for the common 48-72 hours, she had really high fevers with both vaccine doses. Primary Care: She says the primary care doctor's information is the same for her as she provided for her brother. She did not go see him related to this but Pfizer would be welcome to contact him. Event details: Her first dose was given on 24Mar2021. Second dose given on 21Apr2021. With the first dose her fever started on 24Mar2021 and it has recovered completely at this point. She also got the COVID virus from her brother in Nov2020. She says the fever with her first dose went away on the third day, so it went away 27Mar2021. The second dose was 21Apr2021 and the fever began that night same day and lasted until 23Apr. It was high like 104 at multiple occasions. She confirm she has recovered completely from that fever. Product details: She reports lot number from her first dose 046A21A. Lot number from her second dose 001C21A. She does not see NDC or expiration dates. The patient underwent lab tests and procedures which included fever was 104 (high like 104 at multiple occasions) on 21Apr2021. Outcome of the event was recovered on 23Apr2021. Follow-up (PRD/SRD 29Jul2021): No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s): PFIZER INC-2021560230 similar report from same reporter

Other Meds:

Current Illness:

ID: 1518255
Sex: M
Age:
State: NE

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 07/31/2021
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: bruise on my left upper thigh; fungal rash; itch; hives; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old male patient received bnt162b2 (PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered in Arm Left on 21Apr2021 09:15 (age at vaccination: 36-years-old) as dose2, single for covid-19 immunization. Medical history included asthma. Concomitant medication received within 2 weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT), loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to the Covid vaccine. Prior to vaccination patient was not diagnosed with Covid-19. Historical vaccine included first dose of bnt162b2 (PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 24Mar2021 01:15 PM for covid-19 immunization (age at vaccination: 36-years-old). It was reported that a day after second dose, on 22Apr2021 17:30 patient noticed a quarter size bruise on his left upper thigh. A few days later that bruise started to itch. About a week and a half there was bright red hive and bruising that spread all over his upper leg that had an extreme itch then same hives and bruising appeared on his right leg in same general area. His general physician doctor thought it was a fungal rash his treatment did not work then went to dermatologist there treatment of a steroid cream and antihistimine did not work then went to Emergency room where he was prescribed an oral steriod which has helped the itch but the rash/hives have still not gone away. We are going on 3.5 weeks and waiting on a biopsy. Patent was not tested for covid-19 Since the vaccination. Patient was not hospitalized for the event. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of events with Steroid cream, Antihistamines, Oral steroid. Outcome for the events was not resolved at the time of this report. Follow-up (19Jul2021 and 23Jul2021): Follow-up attempts completed. No further information expected.

Other Meds: SYMBICORT; CLARITIN D 12 HOUR

Current Illness:

ID: 1518256
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
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: hives; Swelling of eyes, face; Swelling of eyes, face; Mouth swelling; pressure on her throat with little interruption in her breathing; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, one week after the vaccination, the patient experienced hives. patient also had eye and mouth swelling, and pressure on her throat. She stated the patient had little interruption in her breathing with the pressure on her throat. Patient received 2 Advil as a treatment for events and was just managing her symptoms. Caller asked, should the patient get the second COVID-19 Vaccine shot based on the side effects the patient experienced after the first COVID-19 Vaccine dose. She said the patient's side effects just seemed like hives, and the patient had no difficulty breathing. She said she had read not to get the second COVID-19 Vaccine if there were severe side effects within 4 hours of receiving the first COVID-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. Follow-up: (29Jul2021): This follow-up is being submitted to notify that the new information is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1518257
Sex: F
Age:
State:

Vax Date: 05/02/2021
Onset Date: 05/01/2021
Rec V Date: 07/31/2021
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: Toe area only on the feet hurt- no swelling; right hand- all her knuckles are hurting and swollen; Muscles in her arms and legs are hurting- feels like she has been working out with weights; has no strength in her right hand; right hand- all her knuckles are hurting and swollen; an increase of a flair up of arthritis; swelling in her feet; sleepy; feeling tired; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on 02May2021 (at the age of 65-years-old) as dose 2, single for covid-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unknown date as dose 1, single for covid-19 immunization. On an unknown date in May2021, she was complaining of an increase of a flair up of arthritis and swelling in her feet, feeling tired and sleepy the second day after the vaccine. She began having the following symptoms around the 09May2021, toe area only on the feet hurt- no swelling; right hand- all her knuckles are hurting and swollen; Muscles in her arms and legs are hurting- feels like she has been working out with weights; ripping boxes open at work is difficult, almost like she has no strength in her right hand. On 09May2021, she started feeling joint pains and her muscles hurt like she had been exercising, but she was not exercising. In the past she had arthritis in her left hand and now she has that arthritis pain in all joints and in both hands and feet. It was like her arthritis is flaring up. The first week the arthritis pains would come and go, but since last Monday it has been ongoing non-stop. The arthritis has flared up in other locations other than her left hand, again mentions she only had it in her left hand. Now she has it the right hand and in both in feet and they are swelling. Outcome of events increase of a flair up of arthritis, toe area only on the feet hurt- no swelling and right hand- all her knuckles are hurting and swollen was not resolved while the outcome of other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518258
Sex: F
Age:
State: NY

Vax Date: 05/22/2021
Onset Date: 05/23/2021
Rec V Date: 07/31/2021
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: pain; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer of an unspecified age reported for herself that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an 22May2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23May2021 patient experienced too much pain. Patient asked if she could go to the hospital or take Advil. The outcome of the event pain was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm