chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid Positive
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Neck pain, Pain
Clinical narrative: Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side only including neck and torso left side only X 4 days .
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side only including neck and torso left side only X 4 days .
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Migraine, Nausea, Pain
Clinical narrative: Chills, body aches, migraine, nausea. Improving
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Dizzy, immediately after the injection. Laid on the floor for 5-10 minutes and sat up. Felt better. Able to sit in a chair with no problems.  Reports that this frequently happens after immunizations.  Blood pressure taken 3 times and within normal limits. Monitored for a totla of 30 minutes. released home.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Pain, Pain in extremity
Clinical narrative: Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Injection site bruising, Injection site nodule, Injection site swelling
Clinical narrative: Large swelling, bruising and nodule at injection site right thigh
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy L side of face impacting eye and partial of mouth; not resolved at this time
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever, chills, and nausea starting at 22 hours after vaccine and lasted for 14 hours. L axilla lymphadenopathy starting 38 hours after vaccine.   Treatment was tylenol and ibuprofen prn.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Myalgias, arthalgias, and headache starting at 12 hours after vaccine. These lasted 24 hours. Fever, chills, and nausea starting at 22 hours after vaccine and lasted for 14 hours. L axilla lymphadenopathy starting 38 hours after vaccine.   Treatment was tylenol and ibuprofen prn.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Fatigue, Headache, Injection site discomfort
Clinical narrative: 52 y/o female received Moderna Covid vaccine dose #1 on 12/31, noted some mild injection site discomfort at the time and for several days after.  She developed HA, fatigue after the vaccination    On Tuesday she noted some discomfort in her left axilla and may have felt some enlarged lymph nodes.  Today she noted a swelling in her left deltoid that felt warm to the touch but has not been painful or itchy After getting home she noted a red patch near her left eye.  She denies difficulty breathing or swallowing.  Currently denies fever/chillls, HA. No prior h/o vaccine reaction.  She has not received another vaccine in the past several months.  She is not currently taking any medications including vitamins or supplements Has not yet tried any interventions for her symptoms
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: 52 y/o female received Moderna Covid vaccine dose #1 on 12/31, noted some mild injection site discomfort at the time and for several days after.  She developed HA, fatigue after the vaccination    On Tuesday she noted some discomfort in her left axilla and may have felt some enlarged lymph nodes.  Today she noted a swelling in her left deltoid that felt warm to the touch but has not been painful or itchy After getting home she noted a red patch near her left eye.  She denies difficulty breathing or swallowing.  Currently denies fever/chillls, HA. No prior h/o vaccine reaction.  She has not received another vaccine in the past several months.  She is not currently taking any medications including vitamins or supplements Has not yet tried any interventions for her symptoms
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, Body aches, muscle aches, headache
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: After receiving Covid Vaccine EE c/o tingling in lips no swelling noted no other c/o.  B/p 128/74HR 70 )2 Sat 98% monitored employee for total of 30 minutes RRT and eval in the ED refused upon leaving EE reports the tingling  to be minimal.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Deafness, Disorientation, Fatigue, Syncope
Clinical narrative: Vaccine given Thursday afternoon. Saturday morning had fainting spell. Vision and hearing lost before collapsing and fainting. After a few seconds came to and was disoriented and tired and then shortly recovered. I have no prior history of ever fainting or loosing consciousness.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pyrexia, Renal pain
Clinical narrative: Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sharp bilateral pain noted in kidney region (below ribs). Lower back pain continued to worsen. Pain began to subside by 1000 1/9/2021. No pain by 1400 1/9/2021. Tylenol taken. Did not weaken the symptom. Additional signs and symptoms: Headache. Fever (range 99.2-101.6). Lasting 1/8/2021 (0230) through 1/9/2021 (2000). Tylenol taken for all signs and symptoms. every 8 hours. One pill.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Sudden onset of rash on my back Sunday evening, spreading to most of body by Monday. Applied hydrocortisone 2.5%, took benadryl (2) every 6 hours, prednisone 10mg on Monday, prednisone 20mg on Tuesday.  At this time rash is still active, meeting with dermatologist on 1/13/21
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: One week after receiving my vaccination the injection site became noticeably swollen, red, warm and itchy.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Pallor
Clinical narrative: Vitals, IV started, pale, flushed. EMT responded and treated.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Myalgia, Myocarditis, Pyrexia
Clinical narrative: Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation troponin.  He was evaluated by cardiology and diagnosed with acute myopericarditis.  He was treated with NSAIDs and colchicine.  He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow up.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation troponin.  He was evaluated by cardiology and diagnosed with acute myopericarditis.  He was treated with NSAIDs and colchicine.  He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow up.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pericarditis, Troponin increased
Clinical narrative: Patient presented with myalgias, fevers, and chest pain on 1/10/21 and was found to have diffuse ST elevation and elevation troponin.  He was evaluated by cardiology and diagnosed with acute myopericarditis.  He was treated with NSAIDs and colchicine.  He improved with this treatment and was discharged on 1/12/21 with ibuprofen and colchicine and outpatient cardiology follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Extreme fatigue and headache for a few days so I was unable to complete my daily tasks. I received a call from someone at CDC asking me to fill this out.   I am currently pregnant, 12 weeks along at time of injection. Due date is 07/10/21
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen and painful axillary lymph nodes in the arm of the vaccine administration. Worst day after vaccination progressively improving over 5 days.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Eye symptom
Clinical narrative: 41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell.  Patient's initial symptoms started on 1/8/2021 with some rhinorrhea.  The following day on 1/9/2021 she went to the gym feeling fine.  That evening she felt fatigued and attributed to her workout earlier in the day.  The next day she developed a severe headache with fever, sweats, chills and body aches.  Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms.  Patient presented to the office today on 1/12/2021 for testing and was Covid positive.  Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell.  At that time the duration of her symptoms was 3 days.  She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness.  She had the second Pfizer Covid vaccine on 1/8/2021.  Patient works in administration of a medical facility.  She has minimal contact with clinical staff and patients.  No one in her office has had Covid symptoms or infection.  Patient's other contacts are at home and the gym.  She does attend a gym class with 10 other participants.  She does not know whether anyone in the gym class has had symptoms.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Nasal congestion
Clinical narrative: 41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell.  Patient's initial symptoms started on 1/8/2021 with some rhinorrhea.  The following day on 1/9/2021 she went to the gym feeling fine.  That evening she felt fatigued and attributed to her workout earlier in the day.  The next day she developed a severe headache with fever, sweats, chills and body aches.  Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms.  Patient presented to the office today on 1/12/2021 for testing and was Covid positive.  Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell.  At that time the duration of her symptoms was 3 days.  She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness.  She had the second Pfizer Covid vaccine on 1/8/2021.  Patient works in administration of a medical facility.  She has minimal contact with clinical staff and patients.  No one in her office has had Covid symptoms or infection.  Patient's other contacts are at home and the gym.  She does attend a gym class with 10 other participants.  She does not know whether anyone in the gym class has had symptoms.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive
Clinical narrative: 41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell.  Patient's initial symptoms started on 1/8/2021 with some rhinorrhea.  The following day on 1/9/2021 she went to the gym feeling fine.  That evening she felt fatigued and attributed to her workout earlier in the day.  The next day she developed a severe headache with fever, sweats, chills and body aches.  Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms.  Patient presented to the office today on 1/12/2021 for testing and was Covid positive.  Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell.  At that time the duration of her symptoms was 3 days.  She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness.  She had the second Pfizer Covid vaccine on 1/8/2021.  Patient works in administration of a medical facility.  She has minimal contact with clinical staff and patients.  No one in her office has had Covid symptoms or infection.  Patient's other contacts are at home and the gym.  She does attend a gym class with 10 other participants.  She does not know whether anyone in the gym class has had symptoms.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: The night of vaccination, pt developed a fever, headache, and chills which continued for three days. She was tested for COVID on the second day with a negative PCR result.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram ambulatory normal, Electrocardiogram normal, Heart rate increased, Hypoaesthesia
Clinical narrative: My HR increased to 160, I became dizzy and my left arm felt numb. I was monitored for 30 minutes my HR improved however my BP was low throughout lunch time.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: My HR increased to 160, I became dizzy and my left arm felt numb. I was monitored for 30 minutes my HR improved however my BP was low throughout lunch time.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever >100 21hrs after vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: large warm, raised, 5 inch itchy red injection site reaction
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: sore throat, chills, muscle aches and congestion--covid test negative
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, and fatigue.  Fever and chills resolved with use the of Ibuprofen. Mild fatigue continues
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: began having numbness to face, tingling to hands and legs and dizziness with movement and that her legs were going to give out
Age: 33.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Erythema, Herpes zoster, Pruritus, Rash, Skin warm
Clinical narrative: Rash/heat/Redness/Swelling/itching Left side of face. Emergency Room visit due to list above, Doctor believes to be shingles.
Age: 33.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Swelling face
Clinical narrative: Rash/heat/Redness/Swelling/itching Left side of face. Emergency Room visit due to list above, Doctor believes to be shingles.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Headache Nausea Fever Body aches Fatigue Swelling double the size and redness Lymph nodes swelling and achey
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Headache Nausea Fever Body aches Fatigue Swelling double the size and redness Lymph nodes swelling and achey
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis, Initial insomnia, Pain
Clinical narrative: Pt received immunization @ 1220 she was monitored after immunization for 15min with no side effects. States she went to bed around 9:30pm, was unable to fall asleep.  Developed shaking, chills, sweats and fever 101.5 @ 2am. Did take ibuprofen, some relief from shaking. Continues to have fever, bodyaches, joint pain, chills & sweating.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Pt received immunization @ 1220 she was monitored after immunization for 15min with no side effects. States she went to bed around 9:30pm, was unable to fall asleep.  Developed shaking, chills, sweats and fever 101.5 @ 2am. Did take ibuprofen, some relief from shaking. Continues to have fever, bodyaches, joint pain, chills & sweating.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Facial /neck hives ~ 7 hours after first Moderna covid vaccination.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Skin reaction
Clinical narrative: Redness, erythema, swelling at injection site, outlined Treated with Antibiotics given delayed adverse reaction likely Cellitis
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: -Pain in left hand, wrist to finger tip (like when you lift something heavy)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Chest pain, Cough, Dyspnoea
Clinical narrative: Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; patient received VAQTA that expired on 07/10/2020; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 23-DEC-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S005724 with expiration date 10-JUL-2020, at a dose of 0.5 milliliter (frequency, route and anatomical location were not provided) for prophylaxis. The reporter stated that if the patient had to repeat the dose or not. No other adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005724; expirationdate: 10-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure abnormal, Chills, Heart rate increased, Injection site induration, Malaise
Clinical narrative: knot the size of a turkey egg at the injection site; fever; her systolic was high and other times her diastolic was high; rapid pulse; body aches; chills; thought that she was going to die the night; This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis.   Previously administered products included Zostavax (received 3 to 4 years ago), flu vaccine (received the flu vaccine with no issues) and tetanus vaccine.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise. On an unknown date, the outcome of the injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise were unknown.   It was unknown if the reporter considered the injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and that day there was a knot the size of a turkey egg at the injection site. Now the knot was the size of a poached egg. The knot was not hard and has a fluid consistency. She had fever, chills, body aches, and she thought that she was going to die the night of  13th October 2020. She had a rapid pulse. At times her systolic was high and other times her diastolic was high. The only side effect that she didn't have that was listed on the leaflet was diarrhea according to the patient.  At 15 years of age, the patient claims that she had a tetanus vaccine and had an adverse events, however, she received the flu vaccine with no issues. She got the Zostavax vaccine 3 to 4 years ago. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: knot the size of a turkey egg at the injection site; fever; her systolic was high and other times her diastolic was high; rapid pulse; body aches; chills; thought that she was going to die the night; This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number CZ455, expiry date 16th September 2022) for prophylaxis.   Previously administered products included Zostavax (received 3 to 4 years ago), flu vaccine (received the flu vaccine with no issues) and tetanus vaccine.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise. On an unknown date, the outcome of the injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise were unknown.   It was unknown if the reporter considered the injection site mass, fever, blood pressure abnormal, pulse rapid, general body pain, chills and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and that day there was a knot the size of a turkey egg at the injection site. Now the knot was the size of a poached egg. The knot was not hard and has a fluid consistency. She had fever, chills, body aches, and she thought that she was going to die the night of  13th October 2020. She had a rapid pulse. At times her systolic was high and other times her diastolic was high. The only side effect that she didn't have that was listed on the leaflet was diarrhea according to the patient.  At 15 years of age, the patient claims that she had a tetanus vaccine and had an adverse events, however, she received the flu vaccine with no issues. She got the Zostavax vaccine 3 to 4 years ago. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Headache, Myalgia
Clinical narrative: severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gallbladder disorder, Rash, SARS-CoV-2 test negative
Clinical narrative: Rash on neck; gall bladder attack; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 10:30 at a single dose for  COVID-19 immunization in the hospital, and morphine sulfate (manufacturer unknown), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included S/P rouxen-y gastric bypass, sleep apnea, cholelithiasis, HSV-2, obesity, and Hashimoto hypothyroid disease. The patient was not pregnant at the time of vaccination. Concomitant medications included ursodiol, valacyclovir, levothyroxine sodium (LEVOTH) and vitamins. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced Rash on neck, morphine reaction and May or may not be related - gall bladder attack on 18Dec2020 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was administered with NS bolus, diphenhydramine (BENADRYL) and also morphine in response to the events. Since the vaccination, the patient had been tested for COVID-19 via Nasal Swab/COVID-19 rapid ABBT which was negative on 18Dec2020. The action taken in response to the events for morphine sulfate was unknown. The outcome of the events was recovered with sequel. The patient assessed the events as non-serious.   Pfizer is a marketing authorization holder of morphine sulfate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of morphine sulfate has submitted the same report to the regulatory authorities.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Leukocytosis, Musculoskeletal pain, Myalgia
Clinical narrative: mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered.   Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered.   Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Feeling abnormal, Heart rate increased, Hypoaesthesia
Clinical narrative: blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fingers and later numb face; Mind fog; This is a spontaneous report from a contactable other HCP. This 37-year-old female other HCP (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1685), via intramuscular at left arm on 02Jan2021 08:15 AM at single dose for COVID-19 immunization. Facility type of vaccine was pharmacy or drug store. Medical history included panic disorder (last attack 2 years prior) and known allergies: latex, Iodine dye. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 02Jan2021 08:15 AM, within a few minutes while still under observation at pharmacy, her blood pressure increased and her pulse. Numb fingers and later numb face. Chest pain presented. She went to ER (emergency room) 3hours later with ongoing symptoms that never resolved until 6 or 7 that evening while still in ER waiting room. Mind fog (02Jan2021 08:15 AM) was currently ongoing. The treatment for events included lorazepam (ADIVAN), diphenhydramine (BENADRYL), ibuprofen. Outcome of event mind fog was not recovered, and the rest of events was recovered/resolved with sequel.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Eye pain, Fatigue
Clinical narrative: lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself.  A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Pain in extremity, Rhinorrhoea
Clinical narrative: lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself.  A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: aware of 6 cases of Bell's Palsy by the companies making these vaccines; This is a spontaneous report from a contactable Other HCP. This Other HCP reported similar events for 6 patients. This is 1st of 6 reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported since the use of modified RNA in covid vaccines,he/she had aware of 6 cases of Bell's Palsy by the companies making these vaccines since an unknown date. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Bell's Palsy is not uncommon in general population. The information provided in this case is limited and does not allow a full medically meaningful assessment. The case will be reassessed should additional information become 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.,Linked Report(s) : US-PFIZER INC-2021009409 Different patient, same drug/event.;US-PFIZER INC-2021009412 Different patient, same drug/event.;US-PFIZER INC-2021009410 Different patient, same drug/event.;US-PFIZER INC-2021009411 Different patient, same drug/event.;US-PFIZER INC-2021009408 Different patient, same drug/event.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient had a seizure. Clinical outcome of the adverse event was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: A possible causal relationship between seizure and BNT162B2 cannot be completely ruled out considering the temporal relationship.  However, more information would allow for a full medically meaningful assessment, especially medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date of 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual
Clinical narrative: Hellucinogenic visions of monsters and violent events; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 05Jan2021 at 14:30 on Right arm at single dose for COVID-19 immunization in hospital. The patient medical history included Hypertension, Hypothyroid. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL); Olmesartan; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took and had known allergies with bacitracin zinc;neomycin sulfate;polymyxin b sulfate (NEOSPORIN) and bacitracin zinc;neomycin sulfate;polymyxin b sulfate (POLYSPORIN). The patient experienced hellucinogenic visions of monsters and violent events on 06Jan2021 at 02:00 AM. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.