chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Loss of consciousness, Nausea, Pyrexia, Thirst
Clinical narrative: Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: Went to living room shaky then pass out 2-3 minutes.; chills all day; Cold sweats; little lightheaded/ feeling dizzy; Headache; feels like someone put ice cold on both ears and face; Nauseous; Feverish at night with 99.9 oral temp; Sore on in the injection site; Blurry vision; shaky; thirsty; This is a spontaneous report from a contactable other HCP reported for self. This 49-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 16Jan2021 09:15 AM on Right arm at single dose (Lot # EL1283) for covid-19 immunisation. Medical history included high Blood pressure, Known allergies: Amlodipine, Seasonal allergy. Prior to vaccination, was the patient did not diagnosed with COVID-19. Concomitant medications included Chlorthalidone 25 mg, Magnesium 500mg. No other vaccine in four weeks. The patient previously received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Dec2020 08:30 AM for covid-19 immunisation, experienced sore on in the injection site. On 17Jan2021, waking up 06:00 AM with headache, thirsty, little lightheaded, went to kitchen turn on coffee maker start feeling dizzy, nauseous, blurry vision, went to living room shaky then pass out 2-3 minutes. Cold sweats again, went to bathroom was sitting there then feels like someone put ice cold on both ears and face, cold sweats, nausea, and blurry again. Cold sweats and chills all day, feverish at night with 99.9 oral temp. Sore on in the injection site both doses. No COVID tested post vaccination. No treatments were received. Outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the loss of consciousness and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
Age: 57.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Blood pressure increased, Conjunctival haemorrhage, Eye disorder, Headache, Hypertensive urgency
Clinical narrative: Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of right eye due to new onset hypertension; headache; This is a spontaneous report from a contactable Nurse. This nurse reported for self that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EK9231, exp date and batch were not reported) via unknown route of administration on 13Jan2021 10:00 AM on Left arm at a single dose  for covid-19 immunization. She is not pregnant. Medical history included known allergies: Sulfa (Sulfonamide Antibiotics), Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy. Concomitant medications included Estradiol, Propranolol, levothyroxine/liothyronine (NP THYROID), Aspirin [acetylsalicylic acid], MVI. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Covid-19 mRNA vaccine/Pfizer, lot number: EK5730, exp date and batch were not reported) via unknown route of administration on 23Dec2020 08:00 AM on Right arm at a single dose  for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in fourweeks. The patient experienced Subconjuctival hemorrhage of right eye due to new onset hypertension, headache from 13Jan2021 06:00 PM. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received and started on Lisinopril. No covid prior vaccination. Covid tested post vaccination. The outcome of the event was recovering. Covid test post vaccination included covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid rapid test on 15Jan2021 with covid test result: Negative. on 17Jan2021, covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid with covid test result: Negative.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events conjunctival haemorrhage and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 57.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Conjunctival haemorrhage, Headache, Hypertension, SARS-CoV-2 test negative
Clinical narrative: Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of right eye due to new onset hypertension; headache; This is a spontaneous report from a contactable Nurse. This nurse reported for self that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EK9231, exp date and batch were not reported) via unknown route of administration on 13Jan2021 10:00 AM on Left arm at a single dose  for covid-19 immunization. She is not pregnant. Medical history included known allergies: Sulfa (Sulfonamide Antibiotics), Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy. Concomitant medications included Estradiol, Propranolol, levothyroxine/liothyronine (NP THYROID), Aspirin [acetylsalicylic acid], MVI. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Covid-19 mRNA vaccine/Pfizer, lot number: EK5730, exp date and batch were not reported) via unknown route of administration on 23Dec2020 08:00 AM on Right arm at a single dose  for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in fourweeks. The patient experienced Subconjuctival hemorrhage of right eye due to new onset hypertension, headache from 13Jan2021 06:00 PM. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received and started on Lisinopril. No covid prior vaccination. Covid tested post vaccination. The outcome of the event was recovering. Covid test post vaccination included covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid rapid test on 15Jan2021 with covid test result: Negative. on 17Jan2021, covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid with covid test result: Negative.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events conjunctival haemorrhage and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Electrocardiogram
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247), via an unspecified route of administration at Left arm on 15Jan2021 11:00 AM at SINGLE DOSE for covid-19 vaccination. The patient was not pregnant. Concomitant medications in two weeks included lithium, levothyroxine sodium (LEVOTHROID), omeprazole. Historical Vaccine included first dose of bnt162b2 (lot number EL 1284) on 29Dec2020 11:00 AM at Left arm for covid-19 vaccination. The patient previously took ziprasidone hydrochloride (GEODON) and experienced drug allergies. It was reported no other medical history. On 17Jan2021 the patient woke up with left side of her face dropping. She went to the ER. She was diagnoses with Bell's Palsy. The event onset date was 17Jan2021 04:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment drugs predizone and Acyclovir received for the event. The outcome of the event was not recovered. No covid prior vaccination, no covid tested post vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully 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.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable other HCP (patient). A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL 3247), via an unspecified route of administration at Left arm on 15Jan2021 11:00 AM at SINGLE DOSE for covid-19 vaccination. The patient was not pregnant. Concomitant medications in two weeks included lithium, levothyroxine sodium (LEVOTHROID), omeprazole. Historical Vaccine included first dose of bnt162b2 (lot number EL 1284) on 29Dec2020 11:00 AM at Left arm for covid-19 vaccination. The patient previously took ziprasidone hydrochloride (GEODON) and experienced drug allergies. It was reported no other medical history. On 17Jan2021 the patient woke up with left side of her face dropping. She went to the ER. She was diagnoses with Bell's Palsy. The event onset date was 17Jan2021 04:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment drugs predizone and Acyclovir received for the event. The outcome of the event was not recovered. No covid prior vaccination, no covid tested post vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and tender supraclavicular lymph  nodes; Swollen and tender supraclavicular lymph nodes; This is a spontaneous report from a contactable other health professional (patient).  An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EL1284) via an unspecified route of administration in the left arm, on 13Jan2021 08:30 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, seasonal allergies and gluten sensitivity.  Concomitant medication included montelukast sodium (SINGULAIR) and ethinylestradiol, norethisterone (ORTHO-NOVUM).  The patient previously took flexeril [cyclobenzaprine hydrochloride]; and bnt162b2 (first dose; lot number-EH9899, administration date-23Dec2020, 08:30 AM).  On 13Jan2021 21:00, the patient experienced swollen and tender supraclavicular lymph nodes. The outcome of events was reported as recovering. Patient did not receive any treatment due to the events.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: I received the first part of the Moderna vaccine 1/9/21 in my left arm. On Thursday 1/14 I noticed an enlarged supraclavicular lymph node on the left side. On Friday 1/15 I had some itching on my arm but no visible rash. On Sunday 1/17 there was a large visible rash localized to my left deltoid. The lymph node was causing some neck discomfort as well. I presented to the Urgent Care as was given steroid cream to apply and I have also been instructed to take an OTC antihistamine.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Musculoskeletal discomfort, Pain
Clinical narrative: I received the first part of the Moderna vaccine 1/9/21 in my left arm. On Thursday 1/14 I noticed an enlarged supraclavicular lymph node on the left side. On Friday 1/15 I had some itching on my arm but no visible rash. On Sunday 1/17 there was a large visible rash localized to my left deltoid. The lymph node was causing some neck discomfort as well. I presented to the Urgent Care as was given steroid cream to apply and I have also been instructed to take an OTC antihistamine.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Lymphadenopathy, Musculoskeletal discomfort, Pruritus
Clinical narrative: I received the first part of the Moderna vaccine 1/9/21 in my left arm. On Thursday 1/14 I noticed an enlarged supraclavicular lymph node on the left side. On Friday 1/15 I had some itching on my arm but no visible rash. On Sunday 1/17 there was a large visible rash localized to my left deltoid. The lymph node was causing some neck discomfort as well. I presented to the Urgent Care as was given steroid cream to apply and I have also been instructed to take an OTC antihistamine.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster, Hypoaesthesia, Injection site pain, Lymph node pain
Clinical narrative: Shingles behind left ear the morning after (31Dec2020)Vaccine received; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El1284), via an unspecified route of administration on 30Dec2020 16:30, at left arm, at single dose for covid-19 immunization. Medical history included atopic dermatitis (eczema). No known allergies. Concomitant medication included melatonin.  The patient experienced shingles behind left ear the morning after (31dec2020) vaccine received on 31Dec2020 09:00. Event resulted in Emergency room. The patient underwent lab tests and procedures which included covid test Nasal Swab (Fulgent Genetics) post vaccination: negative on 08Jan2021. Therapeutic measures were taken as a result of shingles behind left ear the morning after (31Dec2020) includes oral Antibiotics, oral Antivirals, antibiotic shot. The outcome of the event was recovered on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based solely on a chronological association, a causal relationship between event "patient experienced shingles behind left ear the morning after vaccination" and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise
Clinical narrative: Shingles behind left ear the morning after (31Dec2020)Vaccine received; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El1284), via an unspecified route of administration on 30Dec2020 16:30, at left arm, at single dose for covid-19 immunization. Medical history included atopic dermatitis (eczema). No known allergies. Concomitant medication included melatonin.  The patient experienced shingles behind left ear the morning after (31dec2020) vaccine received on 31Dec2020 09:00. Event resulted in Emergency room. The patient underwent lab tests and procedures which included covid test Nasal Swab (Fulgent Genetics) post vaccination: negative on 08Jan2021. Therapeutic measures were taken as a result of shingles behind left ear the morning after (31Dec2020) includes oral Antibiotics, oral Antivirals, antibiotic shot. The outcome of the event was recovered on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based solely on a chronological association, a causal relationship between event "patient experienced shingles behind left ear the morning after vaccination" and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test negative
Clinical narrative: Shingles behind left ear the morning after (31Dec2020)Vaccine received; This is a spontaneous report from a contactable other health professional (patient). A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: El1284), via an unspecified route of administration on 30Dec2020 16:30, at left arm, at single dose for covid-19 immunization. Medical history included atopic dermatitis (eczema). No known allergies. Concomitant medication included melatonin.  The patient experienced shingles behind left ear the morning after (31dec2020) vaccine received on 31Dec2020 09:00. Event resulted in Emergency room. The patient underwent lab tests and procedures which included covid test Nasal Swab (Fulgent Genetics) post vaccination: negative on 08Jan2021. Therapeutic measures were taken as a result of shingles behind left ear the morning after (31Dec2020) includes oral Antibiotics, oral Antivirals, antibiotic shot. The outcome of the event was recovered on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.; Sender's Comments: Based solely on a chronological association, a causal relationship between event "patient experienced shingles behind left ear the morning after vaccination" and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Mouth swelling, Nausea, Oral pruritus
Clinical narrative: mouth and tongue became itchy; mouth and tongue became itchy; tongue swelled; headache; nausea; had some trouble breathing; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient (non-pregnant at the vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 18Jan2021 09:45 in right arm at single dose for covid-19 immunization. Medical history included hypothyroidism, allergies: cephalosporins, cipro (ciprofloxacin), levofloxacin, penicillins, kiwi, walnuts, pineapple, certain coatings on fabrics. Concomitant medication included levothyroxine sodium (SYNTHROID), celecoxib (CELEXA), trazodone, cetirizine hydrochloride (ZYRTEK), vitamin d3. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within a few minutes of receiving the injection, her mouth and tongue became itchy, her tongue swelled, she had a headache and nausea and had some trouble breathing on 18Jan2021. Events were reported as non-serious. Events resulted in emergency room/department or urgent care. Treatment of diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and an oral steroid were received for events. Outcome of events were recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: mouth and tongue became itchy; mouth and tongue became itchy; tongue swelled; headache; nausea; had some trouble breathing; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient (non-pregnant at the vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 18Jan2021 09:45 in right arm at single dose for covid-19 immunization. Medical history included hypothyroidism, allergies: cephalosporins, cipro (ciprofloxacin), levofloxacin, penicillins, kiwi, walnuts, pineapple, certain coatings on fabrics. Concomitant medication included levothyroxine sodium (SYNTHROID), celecoxib (CELEXA), trazodone, cetirizine hydrochloride (ZYRTEK), vitamin d3. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within a few minutes of receiving the injection, her mouth and tongue became itchy, her tongue swelled, she had a headache and nausea and had some trouble breathing on 18Jan2021. Events were reported as non-serious. Events resulted in emergency room/department or urgent care. Treatment of diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and an oral steroid were received for events. Outcome of events were recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Nausea, Oral pruritus, Swollen tongue
Clinical narrative: mouth and tongue became itchy; mouth and tongue became itchy; tongue swelled; headache; nausea; had some trouble breathing; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient (non-pregnant at the vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 18Jan2021 09:45 in right arm at single dose for covid-19 immunization. Medical history included hypothyroidism, allergies: cephalosporins, cipro (ciprofloxacin), levofloxacin, penicillins, kiwi, walnuts, pineapple, certain coatings on fabrics. Concomitant medication included levothyroxine sodium (SYNTHROID), celecoxib (CELEXA), trazodone, cetirizine hydrochloride (ZYRTEK), vitamin d3. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within a few minutes of receiving the injection, her mouth and tongue became itchy, her tongue swelled, she had a headache and nausea and had some trouble breathing on 18Jan2021. Events were reported as non-serious. Events resulted in emergency room/department or urgent care. Treatment of diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and an oral steroid were received for events. Outcome of events were recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue pruritus
Clinical narrative: mouth and tongue became itchy; mouth and tongue became itchy; tongue swelled; headache; nausea; had some trouble breathing; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient (non-pregnant at the vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration on 18Jan2021 09:45 in right arm at single dose for covid-19 immunization. Medical history included hypothyroidism, allergies: cephalosporins, cipro (ciprofloxacin), levofloxacin, penicillins, kiwi, walnuts, pineapple, certain coatings on fabrics. Concomitant medication included levothyroxine sodium (SYNTHROID), celecoxib (CELEXA), trazodone, cetirizine hydrochloride (ZYRTEK), vitamin d3. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Within a few minutes of receiving the injection, her mouth and tongue became itchy, her tongue swelled, she had a headache and nausea and had some trouble breathing on 18Jan2021. Events were reported as non-serious. Events resulted in emergency room/department or urgent care. Treatment of diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and an oral steroid were received for events. Outcome of events were recovering.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Plasmapheresis
Clinical narrative: Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram spine, Dysstasia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lumbar puncture, Magnetic resonance imaging brain, Muscular weakness, Plasmapheresis
Clinical narrative: Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia oral, Lumbar puncture
Clinical narrative: Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; the patient's tongue started to go numb; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 18Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from contactable consumers, sibling of the patient and his wife. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. There was no medical history, Family Medical History Relevant to adverse events or concomitant medications. There were no Prior Vaccinations within 4 weeks and no additional vaccines administered on same date of the Pfizer suspect. The sibling of the patient reported the patient had an adverse event after the vaccine that he later described as Guillain Barre. The patient was hospitalized after receiving the COVID vaccine on 08Jan2021. She was admitted to the hospital, the consumer (the sibling's wife) thought, on either 14-15Jan2021. She was not sure of the admitting diagnosis but patient was being treated for Guillain Barre Syndrome. Patient has had a spinal tap on an unspecified date, no results were known. The patient was very healthy, in general the consumer knew she had no typical comorbidities. The reason it was thought to be related was she was perfectly healthy prior and right after she got the vaccine, the patient's tongue started to go numb, that day or the day after (in Jan2021). The events required a visit to Emergency Room, but not to Physician Office. Weight was unknown but the patient was very fit, and BMI (Body mass index) had to be in the normal range. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperaesthesia, Hypoaesthesia
Clinical narrative: Early Bell's Palsy; Facial numbness on the left side of her face; Facial numbness on the left side of her face; Facial numbness and increased sensitivity on the left side of her face; This is a spontaneous report from a pharmacist. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at left arm on 06Jan2021 17:00 at single dose for covid-19 immunization.  Medical history included allergic rhinitis, deviated nasal septum, factor V leiden, gastroesophageal reflux disease (GERD), history of deep vein thrombosis (DVT), hypertension, neck pain on left side, rhinitis, rhomboid muscle strain and pain. No known allergies. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone for pain, sodium chloride. The historical vaccine included the first dose of BNT162B2 (Lot number: EJ1685) via intramuscular at left arm on 17Dec2020 04:15 PM and the paitent did notice some numbness on the right side of face after receiving the first dose of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial numbness and increased sensitivity on the left side of her face. There was no facial droop or lid lag. Other cranial nerves are stable. Concern for early Bell's Palsy would be treated with valganciclovir and prednisone. The adverse events (AE) started from 15Jan2021 09:00. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment valganciclovir 1gm q8h, prednisone 20mg 3-day taper for AE. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.; Sender's Comments: Based on the temporal relationship, the association between the event early Bell's paly with BNT162b2 can not be fully 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.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Increased appetite, Memory impairment, Paranasal sinus hypersecretion
Clinical narrative: Forgetfulness/Lapses in memory; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-years-old male patient received the first dose of bnt162b2 (BNT162B2), lot number EK417, via an unspecified route of administration on 15Jan2021 at 14:00 (at the age of 60-years-old) at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history was none. The patient did not have known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  No other vaccines were in four weeks. The facility where the most recent COVID-19 vaccine was administered was at a nursing home/senior living facility.  On 18Jan2021 at 19:00, the patient experienced forgetfulness/lapses in memory. The patient did not receive any treatment for the event. The clinical outcome of the forgetfulness/lapses in memory was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Memory impairment
Clinical narrative: Forgetfulness/Lapses in memory; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-years-old male patient received the first dose of bnt162b2 (BNT162B2), lot number EK417, via an unspecified route of administration on 15Jan2021 at 14:00 (at the age of 60-years-old) at SINGLE DOSE in the left arm for COVID-19 immunization. Medical history was none. The patient did not have known allergies.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  No other vaccines were in four weeks. The facility where the most recent COVID-19 vaccine was administered was at a nursing home/senior living facility.  On 18Jan2021 at 19:00, the patient experienced forgetfulness/lapses in memory. The patient did not receive any treatment for the event. The clinical outcome of the forgetfulness/lapses in memory was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness
Clinical narrative: Dizziness/ Light-headedness; Diarrhea; Stomach pain & cramps; Chills; This is a spontaneous report from a contactable other health professional (patient). A 33-year-old female patient (pregnant: No) received first dose of bnt162b2 (Lot number: EH9899), via an unspecified route of administration in left arm on 18Jan2021 17:45 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), ethinylestradiol, norgestimate (TRI-SPRINTEC), iron, zinc. The patient experienced dizziness/ light-headedness, diarrhea, stomach pain & cramps, chills all on 19Jan2021 17:45. The outcome of events were not resolved. No treatment for adverse event. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No COVID prior vaccination. No COVID tested post vaccination. Facility type vaccine: Hospital. No other vaccine in four weeks.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness
Clinical narrative: Dizziness/ Light-headedness; Diarrhea; Stomach pain & cramps; Chills; This is a spontaneous report from a contactable other health professional (patient). A 33-year-old female patient (pregnant: No) received first dose of bnt162b2 (Lot number: EH9899), via an unspecified route of administration in left arm on 18Jan2021 17:45 at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), ethinylestradiol, norgestimate (TRI-SPRINTEC), iron, zinc. The patient experienced dizziness/ light-headedness, diarrhea, stomach pain & cramps, chills all on 19Jan2021 17:45. The outcome of events were not resolved. No treatment for adverse event. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No COVID prior vaccination. No COVID tested post vaccination. Facility type vaccine: Hospital. No other vaccine in four weeks.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: I found out im allergic to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, expiration date unspecified), via an unspecified route of administration on 13Jan2021 14:00 at single dose (left arm) for COVID-19 immunization. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergies. On 13Jan2021, at 22:00, the patient found out she was allergic to the vaccine. Treatment was received for the events included antibiotics, pain meds and muscle relaxers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.   Information on the lot/batch number has been requested.