chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on face and near eye; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old male patient received second dose of BNT162B2, lot no. EL3249, via an unspecified route of administration (left arm) on 27Jan2021 05:00 PM at a single dose for Covid-19 immunization at a hospital. Medical history included HTN (hypertension). No allergies to medications, food, or other products. Concomitant medications included losartan, colecalciferol (VIT D3), cyanocobalamin (B 12), ubidecarenone (COQ 10), and fish oil. Historical vaccine included first dose BNT162B2 for Covid-19 immunization on 06Jan2021 05:00 PM (left arm, lot no. EK9231). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient experienced shingles on face and near eye on 30Jan2021 that required doctor or other healthcare professional office/clinic visit. It was treated with Valtrex. The event was reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye irritation, Fatigue, Head discomfort, Headache
Clinical narrative: severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Fatigue, Head discomfort
Clinical narrative: severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: severe swollen lymph nodes in left clavicle and left underarm; headache; burning/heat in eyes; fatigue / Third day had generalized fatigue; chills; fever; full body joint pain; nausea; muscle aches; heavy headed feeling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 11:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 (lot number: EL1284) on the left arm. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and did not had any other medications within 2 weeks of vaccination. On 19Jan2021 13:30, 2 hours after vaccine, patient developed headache and burning/heat in eyes and fatigue. On the first night (19Jan2021), she had chills, fever, full body joint pain, nausea, muscle aches and heavy headed feeling. Next morning on 20Jan2021, she had severe swollen lymph nodes in left clavicle and left underarm. Second night on 20Jan2021, patient had fever, chills, muscle aches. Third day on 21Jan2021, she had generalized fatigue and ongoing severe lymph node swelling. No treatment was received. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. The reporter considered the events non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Lethargy, Malaise, Pyrexia
Clinical narrative: Difficulty breathing; breathing issues; Fever/102.3 F temp/100.3 F temp; General lethargy; Feeling tired; Some coughing; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on the left arm on 27Jan2021 17:15 at single dose for COVID-19 immunisation.  Medical history included coronary heart disease, diabetes, high cholesterol, blood pressure, known allergies: tape and hay fever.  The patient's concomitant medications were not reported.  On 27Jan2021, fever started 2 hours after injection.  Two days of fever, general lethargy and feeling tired.  Third day started out good, but by 8PM, patient stated, "I was running a 102.3 F temp (30Jan2021).  Next morning I as having difficulty breathing.  So on advice of a Teledoc I went to an ER for chest XRAYS.  They told me they believed it was continuing issues with the vaccinations.  168 hours after injection I am running a 100.3 F temp (03Feb2021), still feeling tired, having some coughing and breathing issues". The patient received no treatment. The outcome of the event was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chest X-ray, Cough, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing; breathing issues; Fever/102.3 F temp/100.3 F temp; General lethargy; Feeling tired; Some coughing; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on the left arm on 27Jan2021 17:15 at single dose for COVID-19 immunisation.  Medical history included coronary heart disease, diabetes, high cholesterol, blood pressure, known allergies: tape and hay fever.  The patient's concomitant medications were not reported.  On 27Jan2021, fever started 2 hours after injection.  Two days of fever, general lethargy and feeling tired.  Third day started out good, but by 8PM, patient stated, "I was running a 102.3 F temp (30Jan2021).  Next morning I as having difficulty breathing.  So on advice of a Teledoc I went to an ER for chest XRAYS.  They told me they believed it was continuing issues with the vaccinations.  168 hours after injection I am running a 100.3 F temp (03Feb2021), still feeling tired, having some coughing and breathing issues". The patient received no treatment. The outcome of the event was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pyrexia, Respiration abnormal
Clinical narrative: Difficulty breathing; breathing issues; Fever/102.3 F temp/100.3 F temp; General lethargy; Feeling tired; Some coughing; This is a spontaneous report from a contactable consumer.  A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on the left arm on 27Jan2021 17:15 at single dose for COVID-19 immunisation.  Medical history included coronary heart disease, diabetes, high cholesterol, blood pressure, known allergies: tape and hay fever.  The patient's concomitant medications were not reported.  On 27Jan2021, fever started 2 hours after injection.  Two days of fever, general lethargy and feeling tired.  Third day started out good, but by 8PM, patient stated, "I was running a 102.3 F temp (30Jan2021).  Next morning I as having difficulty breathing.  So on advice of a Teledoc I went to an ER for chest XRAYS.  They told me they believed it was continuing issues with the vaccinations.  168 hours after injection I am running a 100.3 F temp (03Feb2021), still feeling tired, having some coughing and breathing issues". The patient received no treatment. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable lawyer. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 02Feb2021 14:00 at single dose for COVID-19 immunisation. Medical history included ongoing blood pressure high. Concomitant medication included carvedilol for blood pressure high. The patient got first vaccine on Tuesday at 2 PM in the afternoon and last evening, 38 hours later (04Feb2021) at 4 in the morning he got up and almost feel that he was dizzy and he was still dizzy, just a little bit less than maybe before. No treatment received for adverse event. Outcome of event was not recovered.  Information about batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Oropharyngeal pain, Sinus congestion
Clinical narrative: Severe sore throat; sinus congestion; non-productive cough; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (Lot number: El9267), via an unspecified route of administration on 10Feb2021 14:15 at single dose in the left arm for COVID-19 immunization. Medical history included osteoarthritis from an unknown date. Concomitant medication included spironolactone. On 11Feb2021 08:00, the patient experienced severe sore throat, sinus congestion and non-productive cough. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Flu like symptoms; Feeling bad; 1st Shingrix - in March 2020 / series was restarted on 01/05/2021; arm ache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020, refer case US2021002036).   On 5th January 2021, the patient received Shingrix. On 5th January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling bad and drug dose administration interval too long. On 6th January 2021, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On 6th January 2021, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too long was unknown. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient restarted Shingrix series on 5th January 2021 and 4 to 6 hours after vaccination vaccination experienced arm ache. The patient experienced flu-like symptoms and feelig bad. The patient restart series late than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case was linked with case US2021002036, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002036:same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Flu like symptoms; Feeling bad; 1st Shingrix - in March 2020 / series was restarted on 01/05/2021; arm ache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020, refer case US2021002036).   On 5th January 2021, the patient received Shingrix. On 5th January 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, feeling bad and drug dose administration interval too long. On 6th January 2021, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On 6th January 2021, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too long was unknown. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms and feeling bad to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient restarted Shingrix series on 5th January 2021 and 4 to 6 hours after vaccination vaccination experienced arm ache. The patient experienced flu-like symptoms and feelig bad. The patient restart series late than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case was linked with case US2021002036, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021002036:same reporter
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Cardiac failure congestive, Hyperuricaemia, Hypotension, Metabolic acidosis
Clinical narrative: patient presented to ED with confusion and weakness. Given IV fluids and vasopressors for hypotension. Patient's condition continued to worsen, requiring oxygen, AKI with continually worsening renal function on discharge. Patient treated with IV Zosyn for possible infection. Patient continually lethargic and family decided to discharge to home hospice care. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory failure
Clinical narrative: patient presented to ED with confusion and weakness. Given IV fluids and vasopressors for hypotension. Patient's condition continued to worsen, requiring oxygen, AKI with continually worsening renal function on discharge. Patient treated with IV Zosyn for possible infection. Patient continually lethargic and family decided to discharge to home hospice care. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Confusional state, Infection, Lethargy, Renal impairment
Clinical narrative: patient presented to ED with confusion and weakness. Given IV fluids and vasopressors for hypotension. Patient's condition continued to worsen, requiring oxygen, AKI with continually worsening renal function on discharge. Patient treated with IV Zosyn for possible infection. Patient continually lethargic and family decided to discharge to home hospice care. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Hypoxia, Pulmonary embolism, Supraventricular tachycardia
Clinical narrative: 2/12 Patient presented with palpitations, sensation of heat with no chest pain. Of note patient had covid diagnosed 11/20. Work up showed saddle PE and had SVT treated with adenonsine. Treated with IV heparin. Patient on 2L O2 weaned to room air before discharge. Patient transferred to CIRS 2/17. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling hot, Palpitations, Pulmonary embolism, Supraventricular tachycardia
Clinical narrative: 2/12 Patient presented with palpitations, sensation of heat with no chest pain. Of note patient had covid diagnosed 11/20. Work up showed saddle PE and had SVT treated with adenonsine. Treated with IV heparin. Patient on 2L O2 weaned to room air before discharge. Patient transferred to CIRS 2/17. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Patient admitted 2/12 for COVID pneumonia. Started to feel unwell approximately 2-3 days after receiving the vaccine. Presented to ED with cough and weakness. Patient treated with remdesivir/dexamethasone, improved and was discharged 2/14. Readmitted 2/19 for further pneumonia. Improved but requiring 5L of O2. Discharged to rehab 3/1.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Cough, Malaise
Clinical narrative: Patient admitted 2/12 for COVID pneumonia. Started to feel unwell approximately 2-3 days after receiving the vaccine. Presented to ED with cough and weakness. Patient treated with remdesivir/dexamethasone, improved and was discharged 2/14. Readmitted 2/19 for further pneumonia. Improved but requiring 5L of O2. Discharged to rehab 3/1.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Syncope
Clinical narrative: About 32 hours after the 2nd vaccine (2/20/21 at 5 pm) the patient noted an allergic type rash, generalized over his body, that itched so he took benadryl. within the next hour he developed a fever, TMax of 105, so he took tylenol. Other symtpoms included fatigue, dirrhea and myalgias. About  03:00 he woke to go to the bathroom and had a syncopal episode that resulted in a fall during which he cut his lip.  about 20 minutes later he tried to get up and passed out again.  He went to the ER (by that time it was the 2/21/21), where evaluation determined that there was no current cardiac injury or arrythmia.  He was admitted on Observation status to note any arrythmias, none were seen and he was discharged the next day in improved condition.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bilirubin conjugated normal, Blood bilirubin increased, Blood sodium decreased, Dermatitis allergic, Diarrhoea
Clinical narrative: About 32 hours after the 2nd vaccine (2/20/21 at 5 pm) the patient noted an allergic type rash, generalized over his body, that itched so he took benadryl. within the next hour he developed a fever, TMax of 105, so he took tylenol. Other symtpoms included fatigue, dirrhea and myalgias. About  03:00 he woke to go to the bathroom and had a syncopal episode that resulted in a fall during which he cut his lip.  about 20 minutes later he tried to get up and passed out again.  He went to the ER (by that time it was the 2/21/21), where evaluation determined that there was no current cardiac injury or arrythmia.  He was admitted on Observation status to note any arrythmias, none were seen and he was discharged the next day in improved condition.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Fatigue, Lip injury, Loss of consciousness, Myalgia
Clinical narrative: About 32 hours after the 2nd vaccine (2/20/21 at 5 pm) the patient noted an allergic type rash, generalized over his body, that itched so he took benadryl. within the next hour he developed a fever, TMax of 105, so he took tylenol. Other symtpoms included fatigue, dirrhea and myalgias. About  03:00 he woke to go to the bathroom and had a syncopal episode that resulted in a fall during which he cut his lip.  about 20 minutes later he tried to get up and passed out again.  He went to the ER (by that time it was the 2/21/21), where evaluation determined that there was no current cardiac injury or arrythmia.  He was admitted on Observation status to note any arrythmias, none were seen and he was discharged the next day in improved condition.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Rash, Syncope
Clinical narrative: About 32 hours after the 2nd vaccine (2/20/21 at 5 pm) the patient noted an allergic type rash, generalized over his body, that itched so he took benadryl. within the next hour he developed a fever, TMax of 105, so he took tylenol. Other symtpoms included fatigue, dirrhea and myalgias. About  03:00 he woke to go to the bathroom and had a syncopal episode that resulted in a fall during which he cut his lip.  about 20 minutes later he tried to get up and passed out again.  He went to the ER (by that time it was the 2/21/21), where evaluation determined that there was no current cardiac injury or arrythmia.  He was admitted on Observation status to note any arrythmias, none were seen and he was discharged the next day in improved condition.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives since 2/15 not resolved by 3/05, worsening despite medication: famotidine, prednisone, hydroxyzine, benadryl, zyrtec.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Urticaria
Clinical narrative: hives since 2/15 not resolved by 3/05, worsening despite medication: famotidine, prednisone, hydroxyzine, benadryl, zyrtec.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Appendicitis, Computerised tomogram abnormal, Culture wound, Full blood count
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metabolic function test
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain lower, Appendicectomy, Appendicitis, Computerised tomogram, Culture
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count, Human chorionic gonadotropin, Incisional drainage, Metabolic function test, Urine analysis
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Wound infection
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Appendicitis, SARS-CoV-2 test negative
Clinical narrative: appendicitis; This is a spontaneous report from a contactable nurse (patient). This 33-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via intramuscular on 05Feb2021 08:15 at single dose in the left arm for COVID-19 immunisation. The patient's medical history included anxiety, attention deficit hyperactivity disorder (ADHD), reflux, hypothyroid and known allergies: sertraline hydrochloride (ZOLOFT) and metals. The patient's concomitant medications included celecoxib (CELEXA), levothyroxine sodium (SYNTHROID), famotidine, dexamethasone/ofloxacin hydrochloride (FOCALIN), melatonin and multivitamins/plain (MVI) in two weeks. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL8982), via intramuscular on 15Jan2021 11:00 at single dose in the left arm for COVID-19 immunisation. Patient was not pregnant. Patient had no COVID prior vaccination. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced appendicitis on 12Feb2021 06:00, resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (hospitalized for 2 days), life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR (Nasal Swab): Negative on 15Feb2021. Outcome of the event was recovering.; Sender's Comments: The  reported event appendicitis is most likely an intercurrent medical condition in this 33 year old female and is assessed as unrelated to BNT162B2. 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Computerised tomogram thorax, Computerised tomogram thorax abnormal, Confusional state, Diastolic dysfunction
Clinical narrative: COUGH; oxygenation needs quickly escalated; SHORTNESS OF BREATH; A spontaneous report  received from a Healthcare Professional concerning, an 82-year-old male patient who received 2nd dose of the Moderna COVID-19 vaccine and experienced serious adverse events of cough, shortness of breath and hypoxia (reported as oxygenation needs quickly escalated).   The patient's medical history included hypertension and hyperlipidemia. Patient's concomitant medications were not included.   On unknown date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Healthcare Professional stated that Approximately 36 hours after his second vaccination, (on 14-Feb-2021), during a trip with his family, he developed mild cough and SOB that progressed to severe symptoms requiring hospitalization. Healthcare Professional stated patient oxygenation quickly escalated requiring high flow nasal cannula. Patient was initially treated as COVID and high-altitude pulmonary edema. Healthcare Professional stated COVID PCR/ respiratory PCR were negative x 3 and all infectious workup was negative. Healthcare Professional stated the care team began to treat patient with high dose steroids in case of hypersensitivity pneumonitis or eosinophilic lung disease due to vaccination. Patient required a higher level of care but was not stable for transfer home, so the decision was made to transfer patient to ICU where he is currently under the care of ICU and infectious disease specialists. Healthcare Professional stated patient echocardiogram was normal and infectious workup (including COVID and respiratory PCR and cultures) thus far remain negative. Healthcare Professional stated patient is still on high-flow nasal cannula, though skirting intubation. Healthcare Professional feels the process is likely inflammatory versus infectious. Healthcare Professional stated Autoimmune workup is pending.   Treatment included high-flow oxygen, solumedrol and empiric antibiotics.  Action taken with mRNA-1273 in response to these events was not applicable.  The outcome of these events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Echocardiogram abnormal, Ejection fraction normal, Endotracheal intubation, Lung infiltration
Clinical narrative: COUGH; oxygenation needs quickly escalated; SHORTNESS OF BREATH; A spontaneous report  received from a Healthcare Professional concerning, an 82-year-old male patient who received 2nd dose of the Moderna COVID-19 vaccine and experienced serious adverse events of cough, shortness of breath and hypoxia (reported as oxygenation needs quickly escalated).   The patient's medical history included hypertension and hyperlipidemia. Patient's concomitant medications were not included.   On unknown date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Healthcare Professional stated that Approximately 36 hours after his second vaccination, (on 14-Feb-2021), during a trip with his family, he developed mild cough and SOB that progressed to severe symptoms requiring hospitalization. Healthcare Professional stated patient oxygenation quickly escalated requiring high flow nasal cannula. Patient was initially treated as COVID and high-altitude pulmonary edema. Healthcare Professional stated COVID PCR/ respiratory PCR were negative x 3 and all infectious workup was negative. Healthcare Professional stated the care team began to treat patient with high dose steroids in case of hypersensitivity pneumonitis or eosinophilic lung disease due to vaccination. Patient required a higher level of care but was not stable for transfer home, so the decision was made to transfer patient to ICU where he is currently under the care of ICU and infectious disease specialists. Healthcare Professional stated patient echocardiogram was normal and infectious workup (including COVID and respiratory PCR and cultures) thus far remain negative. Healthcare Professional stated patient is still on high-flow nasal cannula, though skirting intubation. Healthcare Professional feels the process is likely inflammatory versus infectious. Healthcare Professional stated Autoimmune workup is pending.   Treatment included high-flow oxygen, solumedrol and empiric antibiotics.  Action taken with mRNA-1273 in response to these events was not applicable.  The outcome of these events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.