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From the 11/12/2021 release of VAERS data:

Found 6,228 cases where Vaccine targets COVID-19 (COVID19) and Manufacturer is PFIZER/BIONTECH and Symptom is Anaphylactic reaction or Anaphylactic shock or Anaphylactoid reaction or Anaphylactoid shock

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Case Details

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VAERS ID: 932322 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-01-07
Onset:2021-01-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactic reaction, Bell's palsy, Erythema, Pharyngeal swelling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hearing impairment (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: COVID19 Pfizer-BioNtech (see previous VAERS report)
Other Medications: cyclobenzaprine prn
Current Illness: None
Preexisting Conditions: History of anxiety and depression
Allergies: No known allergies
Diagnostic Lab Data: As above
CDC Split Type:

Write-up: Anaphylaxis Please note previous VAERS report of Bell''s Palsy 8 days following the first dose and subsequently treated with prednisone and valacyclovir. This neurologic diagnosis was not reported by the patient during the consent process with the COVID19 vaccination center staff. Confirmed following review of the consent form. Documentation from Emergency Department Provider: Patient is serially reassessed following treatment for anaphylaxis. Patient has significant improvement in diffuse erythema and hives within 20 minutes. He has gradual improvement in his sensation of throat swelling. He is observed while in the emergency department serially over 4 hours with no recurrence of symptoms. He does not require any repeat dose of epinephrine and feels at baseline. Discussed my suspicions that patient may have had a reaction to COVID-19 vaccine as he has had no other new medications or exposures that he is aware of. As he will not be receiving another vaccine there is nothing to necessarily stay away from. Make sure he notifies individuals about this for any new vaccine should he receive them. Patient is observed for sufficient time but discussed possibility for biphasic reaction. Recommend he return should he have recurrence of symptoms. Recommend he take EpiPen as prescribed for any throat swelling or progressive shortness of breath. Recommend follow-up with a primary care provider for this visit..


VAERS ID: 933175 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest pain, Cough, Dysphonia, Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pain, Pruritus, Throat irritation, Tongue pruritus, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin, Lamictal, Propranolol
Current Illness: None
Preexisting Conditions: Anxiety/depression, tachycardia, migraines, eczema
Allergies: latex, avocado, mango, penicillin, clindamycin, bactrim, tegaderm, adhesive tape, nickel
Diagnostic Lab Data:
CDC Split Type:

Write-up: Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.


VAERS ID: 933369 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuteral, Loratadine, Fmotidine, Prednisone, Levothyroxine, Epipen (prn)
Current Illness: None
Preexisting Conditions: Migraine headaches, History of papillary thyroid carcinoma, Latex allergy
Allergies: Latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Anaphylactic reaction


VAERS ID: 934475 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Michigan  
Vaccinated:2020-12-29
Onset:2020-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Dysphonia, Dyspnoea, Peripheral swelling, Speech disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ELIQUIS; ; ; CRESTOR; ; SYNTHROID; BENADRYL
Current Illness: Thyroid disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021000598

Write-up: Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient''s hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient''s details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 935361 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2020-12-30
Onset:2021-01-09
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9231 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest X-ray, Electrocardiogram, Full blood count, Metabolic function test, Rash, Rash erythematous, Rash pruritic, Throat tightness, Troponin
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexium Flonase Premphase Multi vits
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: CBC CMP troponin cxr ekg
CDC Split Type:

Write-up: 10days after receiving vaccine developed an anaphylactic allergy after eating shellfish which I was never allergic to. I developed a red itchy rash over the entire body with throat tightening. Went to ER where I was treated with H1 H2 blockers steroids. After being treated and observed for a few hours I re developed the rash and symptoms again requiring further treatment and observation.


VAERS ID: 936011 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-09
Onset:2021-01-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1685 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood potassium decreased, Dizziness, Dysphagia, Electrocardiogram change, Feeling hot, Hypokalaemia, Metabolic function test, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No change from dose #1
Current Illness: No
Preexisting Conditions: Chronic severe idiopathic neutropenia
Allergies: Possibly NSAIDs or unknown
Diagnostic Lab Data: EKG changes, lab draw BMP showed potassium of 2.9 and I dont normally have hypokalemia so I assume it is linked to anaphylaxis especially since the last episode of anaphylaxis I had also resulted in hypokalemia.
CDC Split Type:

Write-up: Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.


VAERS ID: 936219 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021004344

Write-up: anaphylaxis; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylaxis on an unspecified date. The outcome of anaphylaxis was unknown.


VAERS ID: 936551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021009269

Write-up: She thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one; This is a spontaneous report from a non-contactable Other Health Professional via Pfizer sales representative. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. During a conference call, (Name) mentioned that she thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one. It was unclear whether it was after a Pfizer or Moderna vaccine. She did mention that her friend recovered without any issues. Outcome of event was recovered on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender''s Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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.


VAERS ID: 936612 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-06
Onset:2021-01-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Anaphylactic reaction, Chills, Cough, Dizziness, Headache, Hypoaesthesia, Oropharyngeal pain, Pharyngeal paraesthesia, Pruritus, Pyrexia, SARS-CoV-2 test negative, Tachycardia, Throat tightness, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; LEVOTHROID; WELLBUTRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Adrenal insufficiency; Congenital hip dislocation; Hypermobility syndrome; Hypothyroidism; Paroxysmal supraventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210106; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021011058

Write-up: anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender''s Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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.


VAERS ID: 936666 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest discomfort, Dizziness, Dyspnoea, Erythema, Flushing, Headache, Hyperhidrosis, Rash, Tachycardia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021015751

Write-up: Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender''s Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.


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