VAERS 2021 Database www.vaers.hhs.gov

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

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1390728
Sex: F
Age: 56
State: WI

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Product dose omission; Difficulty breathing; Loss of voice; Swelling of throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), APHONIA (Loss of voice) and PHARYNGEAL SWELLING (Swelling of throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing), APHONIA (Loss of voice) and PHARYNGEAL SWELLING (Swelling of throat) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. This is a report of a 66-years female, whose medical history and medications were not provided; who presented an immediate reaction after receiving the first dose of the product. As per medical judgment are not considered life-threatening; thus, as this is a SPONTANEOUS REPORT, seriousness has manually been overridden. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, for the event Product dose omission issue of mRNA-1273, causality is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, for the event Product dose omission issue of mRNA-1273, causality is not applicable.

Other Meds:

Current Illness:

ID: 1390729
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Spontaneous miscarriage; Spontaneous miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Spontaneous miscarriage. Gestation period not reported. At the time of the report, ABORTION SPONTANEOUS (Spontaneous miscarriage) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not provided. Company Comment: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Other Meds:

Current Illness:

ID: 1390730
Sex: F
Age: 42
State: MI

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 06/11/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Blood clots, one on the lung; Gonna pass out; Extremely dizzy; Lightheaded; Little bit of soreness after injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood clots, one on the lung) and LOSS OF CONSCIOUSNESS (Gonna pass out) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD and Diabetes. Concomitant products included INSULIN and OMEPRAZOLE for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Little bit of soreness after injection). On 04-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Gonna pass out) (seriousness criterion medically significant), DIZZINESS (Extremely dizzy) and DIZZINESS (Lightheaded). On 06-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood clots, one on the lung) (seriousness criteria hospitalization and medically significant). On 03-Apr-2021, VACCINATION SITE PAIN (Little bit of soreness after injection) had resolved. On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Gonna pass out) and DIZZINESS (Extremely dizzy) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots, one on the lung) outcome was unknown and DIZZINESS (Lightheaded) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included medications for (diabetic) nerve pain and inhalers used for chronic obstructive pulmonary disease. Treatment for the event included blood thinners. Based on the current available information and temporal association between the use of the product and the start date of the event vaccination site pain, a causal relationship cannot be excluded. Very limited information regarding the events loss of consciousness, dizziness, and pulmonary embolism has been provided at this time. However, the patient's underlying medical conditions remains as confounders. Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event vaccination site pain, a causal relationship cannot be excluded. Very limited information regarding the events loss of consciousness, dizziness, and pulmonary embolism has been provided at this time. However, the patient's underlying medical conditions remains as confounders. Further information is not expected.

Other Meds: INSULIN; OMEPRAZOLE

Current Illness: COPD; Diabetes

ID: 1390731
Sex: F
Age: 61
State: CA

Vax Date: 03/18/2021
Onset Date: 04/16/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Bleeding from the rectum; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Bleeding from the rectum) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 18-Apr-2021, the patient experienced RECTAL HAEMORRHAGE (Bleeding from the rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (Bleeding from the rectum) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. No concomitant medication reported. No treatment medication reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1390732
Sex: F
Age:
State: MA

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: Arm like a cellulitis; Pain in the arm; Itchy arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Arm like a cellulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced CELLULITIS (Arm like a cellulitis) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, CELLULITIS (Arm like a cellulitis), PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown. No concomitant medications mentioned. No treatment information included. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1390733
Sex: M
Age: 70
State: AZ

Vax Date: 03/18/2021
Onset Date: 04/16/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: headache; tiredness; Convulsion; Severe chest pain; Breathing problem; Swelling of his whole body; Severe Allergic reaction; significant drop in blood pressure; Shaking and Tremor all over the body; Pain all over the body; exaggerated pulse at 92 bpm; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B214 and 03114211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Malaria (Had 2 types of Malaria.) and Sick child (Sickly as a child). Concurrent medical conditions included Rheumatic fever and Drug allergy (Allergic to sodium Pentathol). Concomitant products included MULTIVITAMINS [VITAMINS NOS], FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASPIRIN [ACETYLSALICYLIC ACID], TRIAMTERENE, HCTZ, ATORVASTATIN, TERAZOSIN and DICLOFENAC SODIUM (FENDER) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), TREMOR (Shaking and Tremor all over the body), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 16-Apr-2021, SEIZURE (Convulsion) had resolved. On 17-Apr-2021, TREMOR (Shaking and Tremor all over the body) and CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement (120-90 mmHg): low mmHg (Low) 107/65 Significant drop in Blood pressure. On 16-Apr-2021, Heart rate: abnormal (abnormal) Exaggerated pulse at 92 bpm. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; FISH OIL; VITAMIN D [COLECALCIFEROL]; SYMBICORT; ASPIRIN [ACETYLSALICYLIC ACID]; TRIAMTERENE; HCTZ; ATORVASTATIN; TERAZOSIN; FENDER

Current Illness: Drug allergy (Allergic to sodium Pentathol); Rheumatic fever

ID: 1390734
Sex: F
Age:
State: MS

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: had an anxiety attack/the anxiety attack was really out of the ordinary; had a horrible panic attack/having hot fiery panic attacks; bad taste in the mouth; couldn't sleep real well/she can fall asleep, but she cant stay asleep, she recalls on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour; her hands are clammy, she is sweating; her hands are clammy, she is sweating; This is a spontaneous report from a contactable consumer (patient herself). A 62-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm on 19Feb2021 (Batch lot number EN6200) (at the age of 62-year old) at single dose for Covid-19 immunization and alprazolam (XANAX XR) orally at 2 mg in the morning at 6 AM and 1 mg at 1 PM (3 mg daily total) for anxiety. She actually had 2 separate prescriptions: one was a Xanax Extended Release 2 mg pill, and the other was a Xanax Extended Release 1mg pill. Relevant medical history included breast cancer from 2006, high blood pressure and cholesterol abnormal. Concomitant drugs included medication for high blood pressure and cholesterol medication. The patient reported that usually her anxiety was managed by medicine, however after the shot, Friday at noon, it was weird she had a horrible panic attack. She also had the panic attack Sunday, yesterday, and a little today. Her anxiety was always controlled prior to the first dose of vaccine but after the shot, it wass not, her anxiety was out of control. She noticed her anxiety incident probably Saturday morning around 6 AM. She did have complications on Friday 19Feb2021, it was a bad taste in the mouth and she couldn't sleep real well at night. She clarified that she can fall asleep, but she cant stay asleep, she recalled on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour. Anxiety was not controlled: it would say being controlled by her medicine as far as intensity of the anxiety attack. On Saturday and Sunday was the biggest anxiety attack, and it was as if she was not even on the medication that's what it felt like, she was not better, the anxiety was still there. Like during the panic attack her hands were clammy, she was sweating, its an anxiety attack, it could be hormones. This was like as if she was not even taking her Xanax XR, she was having hot fiery panic attacks. She just had a physician appointment 2 weeks before the report (and before the vaccination) and everything was fine: "perfectly fine". The outcome of bad taste was recovering, the outcome of sleep unwell was not recovered while the outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390736
Sex: F
Age: 15
State: NC

Vax Date: 05/23/2021
Onset Date: 05/23/2021
Rec V Date: 06/11/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Patient presented hyperventilating, tachycardic and eventually became apneic and required intubation; had COVID in the past; was COVID IgG positive; troponin normal; ECG sinus tachycardia; all other labs normal on 5/22 and 5/23

Other Meds:

Current Illness:

ID: 1390737
Sex: M
Age: 42
State: NY

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
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Lab Data:

Allergies: NKDA

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: mild/moderate stabbing pain at sternal notch when swallowing starting approx. 3 hours after vaccination, lasted approx. 3 weeks, resolved spontaneously. Did not seek eval/care when symptomatic. no dysphagia to liquid/solid. No airway compromise.

Other Meds: None

Current Illness: None

ID: 1390738
Sex: F
Age:
State: AZ

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: arm still hurts; shortness of breath; her right arm hurt a lot at the injection site; Numbness on right side of nose, mouth, chin, and jaw; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Expiration date: Not reported), via an unspecified route of administration, administered in arm right on 12Feb2021 (Batch/Lot Number: EL9262) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she reported online that the shot did not hurt, states soon after, her right arm hurt a lot at the injection site, on 12Feb2021 evening around 19:00 the right side of her nose went numb, states then the right side of her mouth went numb, states the numbness continued down into chin and jaw on 13Feb2021 (Saturday) and 14Feb2021 (Sunday). Sometimes she feels like she was having shortness of breath, (13Feb2021) started 24 hours later. Reported everything but the shortness of breath online. On an unknown date, the patient reported that her arm is still very achy at site of injection and she doesn't feel like herself. . States the numbness has dissipated. The outcome of the events her right arm hurt a lot at the injection site, arm still hurts was unknown, shortness of breath was not resolved, numbness on right side of nose, mouth, chin, and jaw outcome resolved on an unknown date Feb2021. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1390739
Sex: F
Age:
State: FL

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Sleep, very tired; Vivid dreams; Extremely weak; Soreness on arm; Sweat beads developed; Sensation on both of her hands; chills; Pins and needles; pain, right hip pain, feet pain, joint pain; joint pain; feet pain; This is a spontaneous report from a contactable other hcp. A 68-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 12Feb2021 at 12:00 (at the age of 68-years-old) as 1ST DOSE, single dose for covid-19 immunisation. Medical history included neck surgery from 2015 on an unknown date She had degeneration. Had to have C3 4 5 6 all replaced, ongoing osteopenia Diagnosed with bone scan, Heredity Glaucoma and hormone level abnormal from an unknown date and unknown if ongoing. Concomitant medication included latanoprost taken for Heredity Glaucoma from an unspecified start date and ongoing at 1 drop, once a day [one drop in right each night 0.005% othamlamogic solution], estradiol taken for Low hormones and prevent UTIs via virginal route at 0.5 mL, twice a week from an unspecified start date and ongoing. Patient previously took flu shot and experienced tiredness, sore arm and She got sleepy. On an unknown date in Feb2021 the patient experienced pain, right hip pain, feet pain, joint pain, pins and needles, chills and on 12Feb2021 patient experienced Soreness on arm, Sweat beads developed, Sensation on both of her hands. On 17Feb2021 patient experienced Sleep/ very tired, Vivid dreams and Extremely weak. Caller stated on day 12 the symptoms resolved except for chills from the pelvis down. Caller wanted to know if the second dose could cause the same symptoms to be exacerbated. Mentioned she had surgery on left eye it was so bad with glaucoma so no eye drops needed in left. She had minor symptoms initially. She had soreness in her arm where got injection for 2-3 days. This was like she would have if had the Flu Shot. It was very easy. The soreness started the night got the vaccine, but no redness. About 30 minutes after getting the shot she started to develop little sweat beads on the back of her neck, forehead, and inside of her arms. She also then felt a sensation on both of her hands. To her this was very minor. The sweat beads came and went within just a few seconds. It occurred on her way home from getting the vaccine. Initially confirmed the sweat beads only occurred the 12Feb2021, but later mentioned it may have occurred a day later a couple of times. She always took her temperature and she never had a temperature. It was always 97.4. It was reported that she thought it was all over at first. However, on Day fifth she was hanging pictures in her new home. She was just doing normal household things, nothing big, but she became unusually sleep and tired. She laid down on day 5 and thought she needed a nap. She closed her eyes and was out like a light. She never woke up. During this time she had very weird vivid dreams. She even remembers 2-3 of the dreams she had after she woke up. She was sleeping hard. She felt this was gone and had the best nap of her life. However, she had to wake up after 2 hours because her grandson was coming home whom she has adopted. She wanted to go to the store as well. So she got up and went to the store as well. However, after waking, during that time she felt extremely tired. She felt like she was not really fully awake, but then that feeling went away. When this occurred she was wondering why this was happening. It was day 5 from getting the vaccine and she thought the symptoms should have come and gone by then as most people say on the news, and from reading on smart phone it was just 2-3 days. Also, during this time on day 5, that Wednesday, something else was starting to develop that she had not fully connected yet. She mentioned this part was serious. She was starting to get extremely weak. She was weaker than she should be at her age. She was not weak in her arms at all or her upper body. However, she had a great deal of difficulty getting out of chairs and it got to the point it was very noticeable. However, she did not connect it. She did not know she was supposed to connect it. She was not sure exactly what day these following events started, but she knows she did not have it before in the beginning. Her feet were hurting so badly and she could not stand on them. Her right hip started to hurt like it was a knife going through the joint. The right side was her good leg. She already knows her left leg was weaker than her right leg. She knew her right side was the stronger side. However, this was nothing to keep her from walking 2 hours a day. However, her right hip should have been good, but after the vaccine it became very painful. She also had chills up and down her leg. She thought the chills were gone yesterday and had 100% recovered from it all on day 12, which was yesterday, but she realized while waiting on hold she had the chills again. While waiting on hold for the DSU agent she had chills occasionally, especially right leg and would get some in left leg. It was like legs have been inflamed or joints inflamed. She thought she would have to have hip surgery. She also had pain in pelvic area. The bones there had pins and needles at that time. She had the pelvic pain and would be driving in a car, a nice comfortable car. Her right leg had pins and needles for several days along with hip pain. She had foot pain in both feet. It hurt when she stood and walked, her feet hurt. Yesterday morning when she got up she thought a miracle had occurred. She was able to walk across the floor and did not realize she was even walking. It was like normal again. Everything had gone away like it never happened. She knows in her heart of hearts and after talking to her sister who was a retired pharmaceutical scientist these events are all related to the Pfizer COVID 19 Vaccine and she should report these to Pfizer. She was so happy when they went away yesterday. She was still active and likes to walk. She was able to walk for 2 hours and was not sore when she got home. She was fine. She was like she normally was. Today, she feels normal except the chills in her legs again that was a little bit. She has no pain whatsoever. Yesterday morning it was like the pain had disappeared, like she never had it. She confirmed the pain and pins and needles as recovered with lasting effects as she still has the chills. She hopes and prays the pain never comes back. She was willing to take normal aging arthritic pain if she get it because that was life. The flu shot maybe had tiredness and sore arm. Does not have a lot/exp/NDC to provide. The tiredness was 20-25 years ago. She got sleepy. Outcome of the event chills was not recovered. Outcome of the event Vivid dreams was unknown. Outcome of the events Sensation on both of her hands was recovered on 12Feb2021. Outcome of the event pain, right hip pain, feet pain, joint pain and Pins and needles was Recovered/Resolved with Sequel on 24Feb2021. Outcome of the events was recovered on unspecified date in Feb2021. Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events pain,Paraesthesia and pain in extremity cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: LATANOPROST; ESTRACE VAGINAL

Current Illness: Osteopenia (Diagnosed with bone scan)

ID: 1390740
Sex: F
Age:
State: GA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: she was having an anaphylactic reaction; feeling so bad; It was pained all over; she got a woozy after the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing diabetes, ongoing blood pressure high, coronary artery disease, spinal stenosis, arthritis, Penicillin allergy (doesn't have the product that was back in 1969, Drug hypersensitivity), bee sting, shrimp, ongoing cholesterol, ongoing hypertension. Concomitant medication included insulin aspart (NOVOLOG) taken for diabetes; insulin detemir (LEVEMIR) taken for diabetes, candesartan taken for hypertension; nifedipine (PROCARDIA [NIFEDIPINE]) taken for hypertension; carvedilol taken for hypertension; rosuvastatin calcium (CRESTOR) taken for cholesterol; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took epipen for stung by a bee (stuck that EpiPen in her thigh). The patient experienced she was having an anaphylactic reaction, feeling so bad on 17Feb2021, she got a woozy after the vaccine and it was pained all over on 16Feb2021. Patient stated she received the first dose of the vaccine on 16Feb2021. Caller states she had a severe reaction so dramatic that she has decided that she is not going to take the second dose of the vaccine. When she went in they asked if she had an allergy. She said bee sting, Penicillin, and shrimp. They responded and told her if she had a reaction they had an EpiPen there for her. She has not had an EpiPen injection since 1987. She did not remember what it was like. Back in 1987, she got stung by a bee. She felt so bad. She felt that if she closed her eyes she would die. Her daughter called 911 and they came, but they did not have the EpiPen. Her son called her family doctor who came over with the EpiPen. He said she was having a severe reaction to the bee sting. He saved her life. When she went in on Tuesday she got a woozy after the vaccine. It was not near as bad as what she experienced in 1987. She stayed there 45 minutes and they brought her water and a bagel. She drank the water but did not eat the bagel. She went home and was fine all night. The next morning about 8AM, she started feeling so bad. She felt worse than she did in 1987. She felt like she was going to die if she closed her eye. It did not dawn on her that she was having an anaphylactic reaction. Her friend sent her a text that had four versions of a scripture. The scripture said has different plans for her. She read that to herself and started to feel better. She attributed it to saving her life. She told her cardiologist she is 72 years old and has underlying conditions and she does not want to go through that again. In 1987 the doctor came in the house and the fireman was already there. The doctor came over to her and he just stuck that EpiPen in her thigh. Everything in the body went to the top of her head. She felt like if she could open her head she could let the pain and everything out. Feeling so bad: It lasted for about 15 to 30 minutes. Then caller clarified her friend texted her at 9:26AM, so it may have lasted an hour to an hour and a half. She ached all over. Her body felt dead. It was pained all over. Everything was trapped inside her head. She went to the cardiologist and all her numbers were fine. She told him she was not going to take another shot. She is going to go back for a stress test because she has been diagnosed with coronary artery disease. She has an appointment with her primary care doctor, on 10Mar2021 and will see what he has to say. Time the Vaccination Was Given: her appointment was at 11:30AM. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The adverse events require a visit to Physician Office, She felt better and decided not to take the other shot. She ran it by her doctors. She has an appointment. She has not cancelled it yet. She wants to find out what the ramifications would be if she did not take the second one. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations: She does not have a spleen. She has had her flu shot. She has not had the shingles vaccination. It is not time for Pneumovax. She keeps up and follows her doctors. The patient underwent lab tests and procedures which included numbers: unknown results. The outcome of the events was unknown.

Other Meds: NOVOLOG; LEVEMIR; CANDESARTAN; PROCARDIA [NIFEDIPINE]; CARVEDILOL; CRESTOR; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness: Blood cholesterol abnormal; Blood pressure high; Diabetes; Hypertension

ID: 1390741
Sex: F
Age:
State: NY

Vax Date: 02/19/2021
Onset Date: 02/26/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: blood pressure has been consistently high/ in crisis mode; Severe headache; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 19Feb2021 at 03:45 PM as first dose, single dose for covid-19 immunisation. Medical history included patient had known allergies. The patient received other medications in two weeks (Unspecified). The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. One-week post vaccination, on 26Feb2021 at 07:30 AM patient experienced severe headache and elevated blood pressure readings. Blood pressure was been consistently high ever since and now she was on medication to try to control it. Patient had normal BP readings prior to getting the vaccine on an unspecified date. Now patient was in crisis mode trying to avoid a stroke. The event resulted in visit to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment of blood pressure medication due to the elevated blood pressure. Since the vaccination, the patient hasn't been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure: normal (prior to getting the vaccine) on an unspecified date and blood pressure: elevated on 26Feb2021. The outcome of the events was not recovered. No follow-up attempts are possible; no further information is expected.

Other Meds:

Current Illness:

ID: 1390742
Sex: F
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: fatigue; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 41-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as 2nd dose, single dose (at 41-year-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an 18Dec2020 as 1st dose, single dose (at 41-year-old) for COVID-19 immunization and experienced fatigue and nausea on 18Dec2020. On an unknown date the patient experienced fatigue. The outcome of the event recovered on an unspecified date. Information on the Lot/Batch Number has been requested. Follow-up attempts were completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1390743
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: tinnitus with hearing loss; tinnitus with hearing loss; vertigo and tinnitus with hearing loss; This is a spontaneous report received from a contactable consumer (patient). Follow-up (05Mar2021) information was processed together with initial information. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unknown date, a week later actually, the patient had vertigo and tinnitus with hearing loss. She had received a steroid injection into the ear and her second Covid dose is Friday. She stated do you have an opinion on this matter. Caller was on her way to receive the second dose of the Pfizer Covid 19 vaccine. She wants to know if there could be any interactions from the steroids and the vaccine. Outcome of the events was reported as unknown.

Other Meds:

Current Illness:

ID: 1390744
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 03/08/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: congested, coughing; wheezing a little; Warmness; A wet forehead; achy all over; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 85-years-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st DOSE SINGLE DOSE for covid-19 immunization. Patient medical history included asthma from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing, cough from an unknown date and unknown if ongoing , nasopharyngitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced congested, coughing wheezing, warmness, a wet forehead, achy all over on 08Mar2021 with outcome of unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390745
Sex: F
Age:
State: KY

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: she had chronic diarrhea for a week which started in less than 24 hours after receiving the vaccine and just got better this last weekend; This is a spontaneous report from a contactable Nurse. This (Age-, Unit-unknown) female Nurse (Patient) reported that: Primary source of information: Reporter Qualification: Other Health Reporter Correspondence Contact: False Patient characteristics: Sex: Reaction/Event: MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE Drug Information: Characterization of drug role: (Suspect) Proprietary medicinal product name: Pfizer-Biontech Covid-19 Vaccine Identification of the country where the drug was obtained: Country of authorization/application: Active Substance Information: Active Drug substance names: Pfizer-Biontech Covid-19 Vaccine Narrative case summary and further information: Case narrative: Originating AE Request: REQ # Attachments: 1 Patient Age: Reporter Subtype: Nurse PQC Present: No AE Present: Yes PQC Details: Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller is confirming if there is latex in the stopper of the vial. They were informed by the pharmacist administering the vaccine that there was no latex in the stopper of the vial. She mentioned that she worked with the (Hospital name) in (location withheld) in which they would pop the top off the vial if the patient is allergic to latex. She would also like to know what material the stopper is made from. Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Nice to know that Pfizer is no longer using latex in their vaccines. Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: You were very helpful. Thank you for confirming and making me understand my concern. Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller mentioned that she and her husband both received the 1st dose of the vaccine on 26Feb2021 and experienced side effects. Her husband, (name withheld), aged , experienced a low grade fever with temperatures going up to 99 degree F (his usual temperature is 98 degree F) that lasted for about 24 hours. The next day he went to the ER because of chest pain, but they attribute it to his long heart history. The caller mentioned that she had chronic diarrhea for a week which started in less than 24 hours after receiving the vaccine and just got better this last weekend. She is not sure if this is related to the vaccine. Caller refused transfer to safety as she was busy. E-transferring to department, Possible AE DUplicate. Caller mentioned that she would be happy to provide more information upon follow up. Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: The general public needs to know anything that would trigger a possible severe reaction with the vaccine. Specifically the allergens in your vaccines. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390746
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: patient began to experience lightheadedness/Related Anxiety; Vaccine- Related Anxiety; This is a spontaneous report from a non-contactable Health Care Professional. A 65-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204, Expiration date: Not reported), via an unspecified route on unspecified date as 1ST DOSE, SINGLE DOSE for COVID-19 IMMUNISATION. The patient medical history and concomitant medications were not reported. On unspecified date (15 minutes after vaccination), the patient experienced light headedness. Also reported She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling .The patient received treatment included water and on follow up response to treatment was excellent. It was reported that patient is stable to go home and discharged. It was reported that follow up with PCP as needed and the differential diagnosis: Vaccine- Related Anxiety (include misc mental health) observed for 15 minutes in the bay. She more likely had an anxious moment as she reports she was anxious coming in. VS and exam stable/improved (as reported).The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390747
Sex: F
Age:
State: CA

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Chills, fatigue, soreness, headache; Chills, fatigue, soreness, headache; Chills, fatigue, soreness, headache; Chills, fatigue, soreness, headache; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6199, Expiration date: Unknown), via an unspecified route of administration, in Left arm on 09Mar2021 at 03:45 (at the age of 26-years-old) as 2ND DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL1283, Expiration date: Unknown), via an unspecified route of administration, in Left arm on 16Feb2021 (at the age of 26-years-old) as 1ST DOSE, SINGLE for Covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19, prior vaccination. The patient has been tested for COVID-19, post vaccination. On 10Mar2021, the patient had experienced chills, fatigue, soreness, headache. No treatment received for the adverse events. The patient underwent lab tests and procedures which included Nasal Swab (sars-cov-2 test): unknown on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390748
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: lightheadedness, dizziness; began to experience feeling flushed; Nausea; Difficulty breathing; Rash; Swallowing difficult; Wheezing; Throat tightness; Hoarseness; Stridor; Itching; Facial swelling; Lip swelling; Tongue swelling; This is a spontaneous report from a non-contactable other hcp. A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant drugs was not reported. The patient experienced lightheadedness, dizziness, began to experience feeling flushed, nausea, difficulty breathing, rash, swallowing difficult, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling on Unspecified date. Reported as during her 15-minute waiting period after the injection, the patient began to experience feeling flushed/nausea,rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash).Greatly improved after water/snack/reclining. Therapeutic measures were taken as a result of lightheadedness, dizziness, began to experience feeling flushed, nausea, difficulty breathing, rash, swallowing difficult, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The outcome of the events was resolved on unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390749
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Vaccine-Related Anxiety (include misc. mental health); During her 15-minute waiting period after the injection, the patient began to experience light headedness; This is a spontaneous report from a non-contactable health care professional. A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: Not reported), via an unspecified route of administration on an unspecified date as a 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history included wheel chair user. The concomitant medications were not reported. On an unspecified date, the patient experienced vaccine-related anxiety (include misc. mental health) and during her 15-minute waiting period after the injection, the patient began to experience light headedness, also reported that She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Therapeutic measures were taken as a result of adverse events was as described in physical exam and with water. The outcome of all the events were recovered on an unspecified date. No follow-up attempts are Possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390750
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Headache; Nausea; This is a spontaneous report from a non-contactable Other Health Professional reported for patient. A 26-year-old female patient BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: Unknown), via an unspecified route of administration on an unknown date (at the age of 26-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included dental work and as a corrective measure took ibuprofen at 600 mg, tylenol 500 mg and applied ice pack as well on the neck. Concomitant medications included Ibuprofen at 600 mg and Tylenol at 500mg. On an unknown date, during her 15 minutes waiting period after the injection, the patient had experienced headache and nausea. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient received treatment included water, Tylenol at 500 mg, Ibuprofen at 200 mg and Pepcid at 20 mg. Symptoms was improving with medication treatments as listed. She felt comfortable going home and monitored in the bay for 25 minutes. Follow up response to treatment was good. Patient was discharge as stable to go home. She denied any concerns. Follow up with pcp as needed. Differential diagnosis reported as "red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns)". The outcome of nausea was resolved, and headache was unknown. No follow-up attempts are possible; no further information is expected.

Other Meds: TYLENOL; IBUPROFEN

Current Illness:

ID: 1390751
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: This is a spontaneous report received from a non-contactable other hcp via COVAES. A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) flushed sensation and diaphoresis. During her 15 minute waiting period after the injection, the patient began to experience diaphoresis. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included water. Response to treatment was excellent. Patient discharged she was stable to go home and follow up with PCP. Differential Diagnosis included Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Flushed sensation. Pt observed for 15 minutes. Symptoms resolved. BG good and patient able to ambulate without dizziness, lightheaded, sob, cp. The outcome of event diaphoresis was unknown and all other event were recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390752
Sex: M
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: he had a mild sore arm for a few hours after the vaccine dose; This is a spontaneous report from a contactable other hcp (patient, self-reporting). A 70-years-old male patient received first dose for BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiration dates were not reported), via an unspecified route of administration on 29Jan2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he has been unable to schedule his second dose of the vaccine and has not been contacted about it. he wants to know what to do and if it's ok to get the vaccine later than 21 days on an unspecified date and he had a mild sore arm for a few hours after the vaccine dose on 29Jan2021. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1390753
Sex: M
Age:
State: KS

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Liquid Diarrhea, 2 times. A lot of liquid and smelley; This is a spontaneous report from a contactable male consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: not reported), via unspecified route, administered in left arm on 09Mar2021 02:00 PM as 1st DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication included valproate semisodium (DIVALPROEX) DR 500 mg and 750 mg, Rosuvastatin10 mg in two weeks of vaccination. The patient previously took glyceryl trinitrate (NITROGLYCERIN) and had allergies to it. Patient was not tested positive for covid prior of post vaccination. On 10Mar2021 07:30 am, after the vaccination, the patient experienced Liquid Diarrhoea, 2 times. A lot of liquid and smelly. Imodium was taken as treatment option. Patient had not tested positive post vaccination. The outcome of the was not recovered No follow-up attempts possible. No further information expected.

Other Meds: DIVALPROEX; ROSUVASTATIN

Current Illness:

ID: 1390754
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: lightheadedness; Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health); This is a spontaneous report from a non-contactable other hcp. A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6206) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.On an unspecified date, the patient experienced lightheadedness and differential diagnosis: vaccine-related anxiety (include misc mental health). During her 30-minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, dizziness, facial swelling, lip swelling and tongue swelling. Patient discharged, stable to go home and follow up with PCP. Differential diagnosis included vaccine related anxiety (include misc mental health) anxiety patient observed in bay area for 15 minutes. Improved and was doing well. Patient assisted out via wheelchair by husband. Patient declined help out. She felt well in standing position in the medical bay prior to discharge. Patient declined water and snacks. Follow up with PCP as needed. Therapeutic measures were taken as a result of lightheadedness and differential diagnosis: vaccine-related anxiety. Follow up response to treatment was excellent. The outcome of the events was Resolved on an unspecified date. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390755
Sex: F
Age:
State:

Vax Date: 03/07/2021
Onset Date: 03/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: pain in the injection site; feel sick in her body, arms, and legs; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Expiration date: Not reported), via an unspecified route of administration on 07Mar2021 07:30 1ST DOSE, SINGLE DOSE as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had pain in the injection site for 2-3 days, and 2 hours ago, she started to feel sick in her body, arms, and legs on an unknown date Mar2021. The patient was asking "Can I take Tylenol or Motrin for this? patient was seeking guidance on what to do for the side effects experienced. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390756
Sex: F
Age:
State: CT

Vax Date: 03/09/2021
Onset Date: 03/10/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Aches and pain from neck to lower back; Aches and pain from neck to lower back; Sore left arm site of injection; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female (non-pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 13:45 (at the age of 53-years-old) as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not have any allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not received any treatment and diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On 10Mar2021 16:00 the patient experienced aches and pain from neck to lower back and Sore left arm site of injection. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390757
Sex: F
Age:
State: TX

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: dry mouth; tongue felt lazy; trouble swallowing; light headed/Felt faint; Starting tingling; itching; Face broke out with a rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER, formulation: solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (at the age of 51-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, hypertension, pituitary tumour benign, drug hypersensitivity and food allergy from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. The patient did not have covid prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021, the patient experienced dry mouth and tongue felt lazy for 8-10 minutes, lightheaded/felt faint for 10-12 minutes, itching for 30 minutes, trouble swallowing, tingling and face broke out with a rash. Therapeutic measures were taken as a result of the events. The patient was treated with Benadryl for these allergic reactions. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390758
Sex: M
Age:
State: CT

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Dizzy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Mar2021 06:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient previously took erythromycin and experienced drug hypersensitivity. No covid prior vaccination. No covid tested post vaccination. The patient experienced dizzy on 01Mar2021 06:45. No treatment of the event. The outcome was recovered on 01Mar2021 07:45. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390759
Sex: F
Age:
State: TN

Vax Date: 03/04/2021
Onset Date: 03/05/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: feeling unwell; headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Mar2021 15:00 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. First dose (Lot number: EL9261) was administered on 11Feb2021 03:15 PM, left arm. Medical history included diabetes mellitus, coronary artery disease, osteoporosis. No other vaccine was received in four weeks. Patient received unspecified concomitant medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced feeling unwell on 05Mar2021 07:00, headache on 05Mar2021 07:00, fatigue on 05Mar2021 07:00. No treatment for the events. The events outcome was recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1390760
Sex: M
Age:
State: MI

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Fever; chills; body aches; headache; fatigue; loss of appetite; This is a spontaneous report from a non-contactable consumer (patient). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248) on 10Mar2021 at 14:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 19Fewb2021 at 12:30 pm (lot number EL3248) on left arm. Relevant medical history included Asthma, seasonal allergies, hypertension and Shellfish allergy. Concomitant medications included lisinopril and lansoprazole. On 11Mar2021 at 09:00 am the patient experienced fever, chills, body aches, headache, fatigue and loss of appetite. No treatment was received for the events. The patient recovered from the events on 12Mar2021. No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL; LANSOPRAZOLE

Current Illness:

ID: 1390761
Sex: F
Age:
State: AR

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: heart attack; cardiac problems; inflammatory response; chest pain; fatigue; diarrhea almost every day since the shot, except 2 or 3 days; pain; stomach pain/had a stomach ache in the pit of my stomach like I had a virus; Pain in Ribs; pain in her shoulders; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an intramuscular route on 08Mar2021 (at the age of 68-years) as 1st dose, single dose in the left arm for COVID-19 immunisation. The patient medical history included a list of allergies to various medications. She has a anaphylactic type reactions with contrast, iodine, and opiates, cardiac disorder, bladder infection, immune system problem, carcinoid tumour, severe pneumonia after being in contact with people from South America on Dec2019, experienced 104?F fever, vomit and GI tract infections, it was resolved after sleeping for 3 days and drinking liquids and irritable bowel, tubular adenoma. Concomitant medications were not reported. The patient previously took oral steroids, oral yeast infection medication, and tetracycline cause blisters all over to form. On unspecified date, the patient experienced diarrhoea, fatigue, chest pain, and pain in between ribs, Approximately 5 or 6 hours after vaccination she experienced pain in her stomach and ribs, this continued for up to 36 hours after vaccination, then, she experienced intermittent episodes of diarrhoea. Had also felt very tired, she did not wanted to went outside. Patient took BENADRYL for these symptoms. It was reported that patient had cardiac problems (did not mention the exact condition), after receiving the PFIZER-BIONTECH COVID-19 vaccine she felt pain in her shoulders, thought she was about to had a heart attacked. Due to her heart condition, many medications caused arrhythmias, she was unable to took muscle relaxers, pain medicines, or FLEXERIL. The patient had a history of immune problems (again, did not clarify what conditions), experiences frequent infections and had to used (unidentified) antibiotics, some antibiotics caused GI discomfort and infections. She was thinking that by the time the vaccine dna mixes with her dna. Asks for a resource where she could look up information. After having antibiotic-related as she ate yoghurt and ate a special diet of probiotics. She had a carcinoid tumour that doctors could've found. Patient wants to knew that she was having issues with her stomach and wants to knew how long would this went on. Got the shot on the 8th and it was been 3 weeks. Wants to knew if she could've took buttermilk since it puts the good bacteria backed into the stomach. Patient stated that irritable bowel that did not went away and researched this to helped herself and found foods to heal. She had a carcinoid tumour that they can't got to because she can't took contrast. They gave me contrast at 40 years old and it blew me up liked a blowfish. Patient started doing these shakes and about 6 weeks later, her diarrhoea quits but still had diarrhoea off and on. She bad reactions to antibiotics all the time since it gives me diarrhoea. The stomach ache went away but the diarrhoea continued. She had the diarrhoea almost every day since the shot, except 2 or 3 days. Back in Dec2019, they thought she had COVID since she had a large amount of antibodies so may not needed the second shot (as reported). She had bad diarrhoea after her first COVID vaccine for 10 days. After her second vaccine, it went away. She thought the second shot balanced it out. The outcome of the events was unknown. Follow-up (25Mar2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported that no adverse event coded. Follow-up (31Mar2021): This follow-up contains no new safety information. Follow-up (07Apr2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported that no new event (Not Coded).

Other Meds:

Current Illness:

ID: 1390762
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: tooth ache; Teeth was loose; pain and aggravation; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (BNT162B2; Lot number was not reported), via an unspecified route of administration on an unspecified date (at 78 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was going for her 2nd shot on 12Mar2021. 2 days had a tooth ache (Mar2021) but last night seemed to stop. She did not have any tooth ache for years. Teeth was loose and had pain and aggravation (Mar2021). On 12Mar2021 she felt better, took ibuprofen on 10Mar2021 but not on 12Mar2021. Patient asked if she can get the shot. Final outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390763
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: chills; pains in her body; spasms; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Benadryl for hypersensitivity. The patient experienced chills, pains in her body and spasms on an unspecified date (about 3-4 day after vaccination) with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390764
Sex: F
Age:
State:

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Little itchy; like sensitive skin; I felt a warm tingling sensation; was warm while sitting; This is a spontaneous report from a contactable consumer reported for herself . A female patient of an unknown age reported that received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 25Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. When she got injection, the injection site was warm while sitting for 15 minutes, she felt a warm tingling sensation, then normal like being punched in the arm feeling, how you normally feel when you get a shot. She didn't take anything, didn't sleep on it that night, the second day hurt a little more, it went a way a day or so. She just always felt like her arm didn't feel 100% right, no rash, not swollen, just feels like sensitive skin. Not pain, but as she went through the day, it was feeling more sensitive, when touched it felt a little black and blue, nothing to the eye, just doesn't feel right. Her right arm she felt nothing. She didn't know if it is a tingling sensation, it feels a little itchy, if she was wearing a shirt, it's itchy a little, she was not scratching. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1390765
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 03/11/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: up feeling really dizzy; bad headache; felt like she couldn't walk; This is a spontaneous report from a contactable consumer. This female consumer (patient) of unknown age reported that received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown) on 10Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. The next day she woke up feeling really dizzy, like a really bad headache, felt like she couldn't walk. At the time of reporting the outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1390766
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: arm was a little sore; breaking out in hives; itching and little blotches on her skin; itching and little blotches on her skin; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on Mar2021 at single dose for COVID-19 immunization. medical history included she is allergic to pollen. She felt all right after vaccination. Her arm was a little sore. However, since unknown date in Mar2021, she's been "breaking out in hives". She has "bumps on her arm and neck". She stated she feels all right but noticed she's "itching and little blotches on her skin, around her neck and some on her thighs". She took Benadryl. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1390767
Sex: F
Age:
State: CA

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Left side of face and tongue got numb and tingly; Left side of face and tongue got numb and tingly; Left side of face and tongue got numb and tingly; Left side of face and tongue got numb and tingly; This is a spontaneous report from a contactable consumer (patient) via a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) (at the age of 63-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that within a few minutes after receiving the vaccine, the left side of her face and tongue got numb like it was treated with Novocaine. Her medical doctor (MD) told her to pre-treat her second dose (scheduled for 31Mar2021) with Tylenol and Benadryl. On 12Mar2021, the patient reported that she received the first COVID vaccine on 10Mar2021 and 25 minutes after, her left side of face and tongue got numb and tingly. It is almost back to 100% now of feeling normal. Her healthcare professional (HCP) said to take Benadryl before the second COVID vaccine. She is making sure that this will be ok to do. The outcome of the events was recovered on 12Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390768
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: feeling "tired"; This is a spontaneous report from a non-contactable consumer (patient). A female consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient felt very tired on unknown date. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390769
Sex: M
Age:
State: NY

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: lightheadedness; not myself; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11Mar2021 at 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. The patient felt fine on the day of the first vaccine dose. On 12Mar2021, he felt not himself, lightheadedness. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1390770
Sex: M
Age:
State:

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: blood pressure was high 190/114; horrible dizzy spells/ lightheadedness; when he puts his head between his shoulders he almost falls over; nauseous; sweating; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 03Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Mar2021 patient experienced horrible dizzy spells, lightheadedness, when he puts his head between his shoulders he almost falls over, blood pressure was high 190/114, nauseous, sweating. Patient stated that he received the first dose of the Pfizer COVID vaccine on 03Mar2021. He did not have any problems directly after the vaccine. Patient started having problems the middle of the week of the report with horrible dizzy spells and lightheadedness. Patient stated that when he puts his head between his shoulders he almost falls over. He was taken to the emergency room by ambulance and had an Electrocardiogram (EKG) done in Mar2021 that was normal. Patient stated that his blood pressure was high 190/114 and he was given medication for it. Patient had been nauseous and sweating. Patient had read on the internet that other people have had this same experience. He stated that his symptoms are really debilitating. Patient wanted to know how long his side effects will last, wanted to know if his side effects are normal and if he should receive the second dose of the vaccine. Events resulted in emergency room visit. Outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390771
Sex: F
Age:
State: NY

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: patient described soreness in arm and limited ability to lift it; patient described soreness in arm and limited ability to lift it; fever of 100.0 F; fatigue; body ache; no appetite; This is a spontaneous report from a contactable consumer. A 37-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201), via an unspecified route of administration on 10Mar2021 14:30 as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19.Previously on 17Feb2021 patient took the first dose of the vaccine (lot EL9269) at the age of 37 years for covid-19 immunisation. On 10Mar2021 the patient experienced soreness in arm and limited ability to lift it, fever of 100.0 F,fatigue, body ache and no appetite. It was unknown if treatment was given. Outcome of the events was recovering.No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1390772
Sex: M
Age:
State: VA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: severe dehydration; severe dehydration; thirst; could not sleep at night/ lack of sleep/ sleep interrupted; she had never heard him so anxious or disturbed that he could not get relief; she had never heard him so anxious or disturbed that he could not get relief; This is a spontaneous report received from a contactable consumer (medical technologist). A 19-year-old male patient (reporter's grandson) received BNT61B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on 04Mar2021 (at the age of 19-year-old) as 1st dose, single dose for COVID-19 immunisation. Vaccine was not administered at military facility. The patient's medical history included diabetic (since 1 years old, he was diagnosed 1 week after getting the measles/mumps/rubella (MMR) vaccine), dehydrated and rapid heartbeat (patient once before got dehydrated on the Hiking Trail with a rapid heartbeat). The patient's concomitant medications included insulin for diabetic. The patient previously received measles/mumps/rubella (MMR) vaccine. The reporter (caller) mentioned that his grandson got the 1st dose of the vaccine on 04Mar2021. Several hours later (04Mar2021), he experienced severe dehydration and thirst and could not sleep at night. He was very very uncomfortable and usually did not complain regarding experiences. He was young and going to college and he was living on his own. He was also diabetic. She was worried about his safety regarding his intake of the 2nd dose, so she was wondering if this had been reported and for any recommendations before and after getting the 2nd dose. They were consulting with his endocrinologist and the nurse at the endocrinologist's clinic said that they recommend young diabetic people to drink tons of water when getting the vaccine. Caller mentioned that she herself got the Pfizer vaccine and had no problem with it. Caller mentioned that his Grandson was diabetic since 1 years old. He was diagnosed 1 week after getting the MMR vaccine. She also mentioned that his grandson just recently got in college and he was in the younger side of the spectrum. Caller is asking if there is any data that would include her grandson's conditions in the clinical trials. Caller stated she was calling about the Pfizer COVID Vaccine and stated her grandson who was the patient was the one who received his first dose of the vaccine on 04Mar2021 and that day he received the vaccine he told her that starting in the evening that same day (04Mar2021) she had never heard him so anxious or disturbed that he could not get relief and the adverse reaction he had was severe dehydration and thirst and it was giving him a fit. Caller stated she thinks he was probably 5'10'' in height or so and thinks he weighed around and between 175-180 pounds when she last asked him. Caller stated she was not an HCP but was a medical technologist calling on behalf of the patient and because she was a medical technologist, she is medically trained. Caller stated she had not been able to get back in touch with the patient to get all the details for the report before she called around to get help but also stated the patient had his sleep interrupted after the vaccine was administered and he could not sleep but thinks this is all resolved and must have been resolved but she couldn't say for certain how long that he could not sleep or how long the severe dehydration or thirst lasted but she can find out. Caller stated the patient had not yet had the 2nd dose of the Pfizer COVID Vaccine and had his patient card and stated she did not have the lot, expiry date or NDC for the first dose. Caller stated for the indication for which the patient was administered the COVID vaccine, she thought because the patient was diabetic and the HCP was very anxious for him to have defense against COVID and against all various types of virus or the school may have required it but she was not sure; states it was for the patient's own safety that his endocrinologist wanted him to have the vaccine. Caller stated that the patient did not have treatment for the reported event and he did not say to her that he had any treatment; caller stated she doubted the infirmary at his school is even open at the University and she did not know whether the patient would go to the infirmary or not. Caller stated she was calling to find out of there have been any reports or feedback on this reaction that the patient had or the adverse situation the patient had several hours after receiving the Pfizer COVID Vaccine; states specifically for the severe dehydration and thirst the patient experienced after being administered the Pfizer COVID Vaccine. Caller stated the patient was due to get his 2nd dose of the Pfizer COVID vaccine three weeks from 04Mar2021 and she was most anxious to find out what recommendations were given or if Pfizer heard complaints about other adverse events like the ones she was reporting on the patient. Caller stated the patient once before got dehydrated on the Hiking Trail with a rapid heartbeat and he was with his father at that time; no further details provided by the caller. Caller stated the patient reported this to her in conversation a day or so after he had the Pfizer COVID Vaccine and she is medically trained and it has been a long time since she used that medical training but the patient is diabetic since the age of 1 and he had good care and has been under the care of the hospital endocrinologist and his HCP since he was found to have diabetes and he uses his insulin pump very well. Caller stated the patient was off to college where very few were attending college and the patient had a very undesirable evening after the vaccine of lack of sleep and he was so thirsty and could not get hydrated and she knows dehydration is bad for anybody even if they aren't diabetic or if they have a life threatening type of illness but the patient was at school and did not have a family member to help take care of him and he was due for his 2nd shot three weeks from 04Mar2021. Caller stated she was trying to find out the best route for him to go report this and she told him to report the reaction to the HCP and to call the HCP who prescribed the vaccine; stated the patient's endocrinologist was not able to get in touch with the patient and he was not answering the phone; stated the patient is at college and he was on online courses. Caller stated she was very anxious to find out enough information about this and it is a concern to his treating physician and she was asking about recommendations about the patient not having his 2nd dose of the Pfizer COVID Vaccine; stated she spoke with the nurse that works with the endocrinologist for all of these 18 years they have cared for the patient. Caller states the HCP's nurse stated she had found that patients that receive the vaccine and have diabetes and are treated at the hospital they recommend that those patients drink tons and tons of water before having the vaccine because some types of people with diabetes have extreme thirst. Caller stated she had no vaccine names, patient information or lot number or other information to provide on the patients that had the vaccine and have diabetes. Caller stated she spoke at the HCP office and stated there was no need for secrecy and HIPPA was not in Pfizer's domain; stated she cannot depend on the patient to look out for his own safety and she as a medical technologist used to give patients ordered glucose tolerance tests and she knew of the reactions that occurred with those patients and she did not want the patient to be stuck and wanted for him to do the smart thing of spending the night at home rather than drive back. Caller stated for those patients she administered glucose tests to she had no patient information or lot numbers or other information to provide and it was years ago before the Pfizer COVID vaccine came out. Caller stated she worked trying to get patient's diabetes under control at the University where she worked. Caller stated she already called and waited for organization but did not speak to anyone and left them a number to call her back a couple of days ago but she had not heard back; st

Other Meds: INSULIN

Current Illness:

ID: 1390773
Sex: M
Age:
State:

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Onset Date:
Rec V Date: 06/11/2021
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Allergies:

Symptom List: Vomiting

Symptoms: not feeling good; pulsating at the injection site/arm; when will his taste buds will be back or the smell.; when will his taste buds will be back or the smell.; fever; dizziness; muscle aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, at 1st dose, single dose for COVID-19 immunization. Medical history included COVID in Oct2020. Concomitant medications were not reported. The patient had COVID back in the Oct2020 and after taking first dose of BNT162b2 he was experiencing all the symptoms which he experienced with the COVID-19: fever, dizziness, muscle aches, nausea, not feeling good, pulsating at the injection site/arm. He wanted to know about if he was contagious and when would his taste buds would be back or the smell. The patient had not recovered from when will his taste buds will be back or the smell, the outcome of the other events was unknown. Follow-up attempts are completed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390774
Sex: F
Age:
State: CT

Vax Date: 03/01/2021
Onset Date: 03/11/2021
Rec V Date: 06/11/2021
Hospital:

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Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: prickly heat rash; itchy rash; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date in Mar2021 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asked if she should receive the 2nd dose if she had an itchy rash all over her body 8 days after the 1st dose on 11Mar2021. She had an extremely itchy rash all over her body. It came on suddenly. It occurred 8 days after the 1st dose. It looked exactly like a prickly heat rash. She called her doctor, but he said they have nothing to do with the vaccine declined to offer any management. She took diphenhydramine (BENADRYL) and used a DOMEBORO compress. The side effect did go away. This started the day before the present report in the afternoon (11Mar2021). It worsened throughout the night. The case was reported as non-serious. The outcome of the events was resolved. No follow-up attempts are needed; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1390775
Sex: F
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/11/2021
Hospital:

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Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: she reports a headache only on her right side of her head; weakness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on 09Mar2021 (at 73 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weakness on 09Mar2021 and next night (10Mar2021) she reported a headache only on her right side of her head. She wanted to know if she can still have the second dose of the vaccine as scheduled on 29Mar2021, the day before at night time a headache in the right side of head. The final outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1390776
Sex: M
Age:
State: MD

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 06/11/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: sleeping more than used to/11-12 hours of sleep; lot more fatigue than usual; night sweats; muscle soreness at injection site; muscle fatigue in various spots of the body; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included myalgia, urinary tract infection. The patient's concomitant medications were not reported. The patient experienced muscle soreness at injection site on 06Mar2021, muscle fatigue in various spots of the body on 06Mar2021, sleeping more than used to/11-12 hours of sleep on an unspecified date, lot more fatigue than usual on an unspecified date, night sweats on an unspecified date. The events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390777
Sex: F
Age:
State: NY

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/11/2021
Hospital:

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Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Lot of allergy; Itching on her eyes; Face was flushed, it looked red; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 09Mar2021 (batch/lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included COVID from Apr2020 (had COVID before the vaccine), high blood pressure, cholesterol (abnormal), diabetes, and circulatory problems. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 in the morning of 09Mar2021. She was monitored for half an hour and she was fine. An hour later, the patient started feeling itching on her eyes, and later that evening, her face was flushed, it looked red like she had "a lot of allergy". The patient went to the hospital and she received 3 medicines for 4 days. The patient still had some flush. The doctor told the patient she cannot get the second dose. She had COVID in April before the vaccine. The patient wanted to know if she had antibodies left. Besides, she has high blood pressure, cholesterol, diabetes, and circulatory problems. The patient needed to travel and therefore needs the 2 doses, but if she can't get the second, she wondered what will be written on her vaccination card. The second dose was scheduled for 30Mar2021. The outcome of the event flushed face was not recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390778
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
Hospital:

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Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: experienced some itching at the injection site in left arm; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included memory impairment ongoing from an unknown date. The patient's concomitant medications were not reported. The patient experienced some itching at the injection site in left arm on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Memory impairment

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am