chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Cough, Dyspnoea, Electrocardiogram, Eosinophil percentage
Clinical narrative: The patient is a 57 year old female who presents to the ED with an allergic reaction. Patient received her COVID vaccine this morning at a vaccine POD at 0708, 5 minutes after receiving the injection she began to feel short of breath, with dry cough and felt tightness in her throat. Patient used her inhaler at that time and then her symptoms improved.  Of note patient also took a Benadryl prior to receiving the vaccine because she has a history of allergies (reports allergy to codeine ). She was evaluated by people at Covid vaccine site and cleared.  She went to work at the clinic where she works as a tech but continued to have tightness in her throat, so a doctor at the facility told her to take another Benadryl. Patient states that an hour after taking the second dose of Benadryl she began to feel drowsy and nauseous.  She had a sip of coffee and try to eat something but then became tremulous and vomited.  She was given epinephrine at work and transferred here for further work-up and management.  On arrival patient reports that she feels back to baseline.  She denies at any time having any rash, pruritus, or angioedema.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Globulins increased, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: The patient is a 57 year old female who presents to the ED with an allergic reaction. Patient received her COVID vaccine this morning at a vaccine POD at 0708, 5 minutes after receiving the injection she began to feel short of breath, with dry cough and felt tightness in her throat. Patient used her inhaler at that time and then her symptoms improved.  Of note patient also took a Benadryl prior to receiving the vaccine because she has a history of allergies (reports allergy to codeine ). She was evaluated by people at Covid vaccine site and cleared.  She went to work at the clinic where she works as a tech but continued to have tightness in her throat, so a doctor at the facility told her to take another Benadryl. Patient states that an hour after taking the second dose of Benadryl she began to feel drowsy and nauseous.  She had a sip of coffee and try to eat something but then became tremulous and vomited.  She was given epinephrine at work and transferred here for further work-up and management.  On arrival patient reports that she feels back to baseline.  She denies at any time having any rash, pruritus, or angioedema.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume abnormal, Monocyte count increased
Clinical narrative: The patient is a 57 year old female who presents to the ED with an allergic reaction. Patient received her COVID vaccine this morning at a vaccine POD at 0708, 5 minutes after receiving the injection she began to feel short of breath, with dry cough and felt tightness in her throat. Patient used her inhaler at that time and then her symptoms improved.  Of note patient also took a Benadryl prior to receiving the vaccine because she has a history of allergies (reports allergy to codeine ). She was evaluated by people at Covid vaccine site and cleared.  She went to work at the clinic where she works as a tech but continued to have tightness in her throat, so a doctor at the facility told her to take another Benadryl. Patient states that an hour after taking the second dose of Benadryl she began to feel drowsy and nauseous.  She had a sip of coffee and try to eat something but then became tremulous and vomited.  She was given epinephrine at work and transferred here for further work-up and management.  On arrival patient reports that she feels back to baseline.  She denies at any time having any rash, pruritus, or angioedema.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte percentage, Nausea, Neutrophil count increased, Platelet count normal, Protein total normal
Clinical narrative: The patient is a 57 year old female who presents to the ED with an allergic reaction. Patient received her COVID vaccine this morning at a vaccine POD at 0708, 5 minutes after receiving the injection she began to feel short of breath, with dry cough and felt tightness in her throat. Patient used her inhaler at that time and then her symptoms improved.  Of note patient also took a Benadryl prior to receiving the vaccine because she has a history of allergies (reports allergy to codeine ). She was evaluated by people at Covid vaccine site and cleared.  She went to work at the clinic where she works as a tech but continued to have tightness in her throat, so a doctor at the facility told her to take another Benadryl. Patient states that an hour after taking the second dose of Benadryl she began to feel drowsy and nauseous.  She had a sip of coffee and try to eat something but then became tremulous and vomited.  She was given epinephrine at work and transferred here for further work-up and management.  On arrival patient reports that she feels back to baseline.  She denies at any time having any rash, pruritus, or angioedema.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count decreased, Throat tightness, Tremor, Vomiting, White blood cell count increased
Clinical narrative: The patient is a 57 year old female who presents to the ED with an allergic reaction. Patient received her COVID vaccine this morning at a vaccine POD at 0708, 5 minutes after receiving the injection she began to feel short of breath, with dry cough and felt tightness in her throat. Patient used her inhaler at that time and then her symptoms improved.  Of note patient also took a Benadryl prior to receiving the vaccine because she has a history of allergies (reports allergy to codeine ). She was evaluated by people at Covid vaccine site and cleared.  She went to work at the clinic where she works as a tech but continued to have tightness in her throat, so a doctor at the facility told her to take another Benadryl. Patient states that an hour after taking the second dose of Benadryl she began to feel drowsy and nauseous.  She had a sip of coffee and try to eat something but then became tremulous and vomited.  She was given epinephrine at work and transferred here for further work-up and management.  On arrival patient reports that she feels back to baseline.  She denies at any time having any rash, pruritus, or angioedema.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Muscle spasms, Paraesthesia, Radiculopathy
Clinical narrative: Vaccination to right deltoid; 7 days later developed diminished grip strength in right hand, right thoracolumbar muscle spasm with tingling radiculopathy to right hand and leg
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Started out as a sore arm about 4 hours after getting the shot. Then progressed to severe body aches and a headache about 8 hours after getting the shot. Then after about 10 hours  post-vaccine it progressed into chills and a 100.0 degree fever. I took 2 Tylenol Extra Strength pills at 12 hours post-vaccine and the symptoms decreased significantly within an hour.  Still experiencing mild symptoms of all of the above.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Delusion, Fatigue, Joint swelling
Clinical narrative: Severely delusional, elevated high BP, vertigo, chills,  moderate  fatigue,  swollen  ankles,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severely delusional, elevated high BP, vertigo, chills,  moderate  fatigue,  swollen  ankles,
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Night sweats
Clinical narrative: Headache, night sweats
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Nausea (dry heave), Light-headedness, slight hand tremors, increased respirations, pain and warmth at injection site, tiredness, slight facial skin tightening, tingling of hands and feet
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Respiratory rate increased, Retching, Skin tightness, Tremor
Clinical narrative: Nausea (dry heave), Light-headedness, slight hand tremors, increased respirations, pain and warmth at injection site, tiredness, slight facial skin tightening, tingling of hands and feet
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue disorder
Clinical narrative: PT RECEIVED Pfizer-BioNTech COVID-19 Vaccine. During observation period, pt felt as though her tongue was "thick" and her lips were tingling. Pt took a Claritin Ready Melt 10 mg tablet and sat under observation for addition 30 minutes. Symptoms subsided and pt left pharmacy area. She will carry her Epi-Pen with her for the next couple days.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Leg muscle pain in quadriceps in both legs, headache, nausea, one instance of vomiting
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms
Clinical narrative: No symptoms during the mandatory 15 minute post-vaccine period in clinic waiting area. Experienced mild fatigue/general tiredness approximately 6-7 hours after receiving vaccine (given 12:35 pm). Full body chills/muscle spasms then occurred around 9:30 pm and lasted about 40 minutes.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Fatigue, Headache, Brain fog, Body Aches, Nausea, Malaise, Fevers, Exhaustion, SOB
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, Headache, Brain fog, Body Aches, Nausea, Malaise, Fevers, Exhaustion, SOB
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea, Pruritus, Retching
Clinical narrative: 5 minutes post-injection onset of nausea.  10 minutes post-injection retching.  1 hour post injection intense abdominal pain.  2 hours post injection onset of full body itching with no rash or hives.  Itching responded to 50 mg Benadryl po and 20 mg po pepcid.  Next day light itching; no other symptoms
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Patient is experience severe muscle spasms and myalgia in shins with extreme pain in toes of the right leg (previously injured leg, chronic pain). She has tried to take lyrica, but has not seen a doctor yet. Plans on following up next business day.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Headache
Clinical narrative: As employee entered observation area noted slight headache then complained of SOB  VS BP 150/90 states took medication in am O2 Sat 99-100% HR-74 RR-24 lung sounds clear  reported lightheadedness, confusion sent to ED via wheelchair
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Employee received vaccine on 12/17/20 on 12/18/20 employee noted red rash to abdominal area. Raised no drainage
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: received vaccine at 9:30 am  noted frontal headache @ 9:40am VS 124/76 HR 75 O2 Sat 95%  Denied SOB, difficulty swallowing, numbness tingling given acetaminophen 650 mg 9:50 am given ibuprofen 600mg @ 10:22am  VS BP 137/90 HR 71, O2 Sat 97%, feeling dizziness nausea, transported to ED
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: received vaccine @ 4:25pm within few mins noted red flush across face, neck extending to collar bones.  No SOB, difficulty swallowing, hives, rash nausea  BP 142/80 HR 64 O2 Sat 97% 15mg of liquid Benadryl @ 4:35pm resolved in 1 hr
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Flushing, Palpitations
Clinical narrative: Tasted the medication, felt flushed, heart racing, BP 166/118 P 125 PO2 100% Repeat BP 150/106 P90's Rapid response RN here BP 159/89 P 89
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Ear pruritus, Pruritus, Rash, Throat irritation
Clinical narrative: Appoximately 12:15pm patient Reporting itching all over her body, throat feeling scratchy, bumps forming on chest, ear itching. Vital signs taken Benedryl 12.5 mg given IM x2. pepcid given orally, continued to monitor x 60 min. Itching was Reduced over body, bumps on skin Resolved. Temperature Rose from 97.2F to 99.4F.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Pt. states an hour after, she started a 2-3/10 headache, after 2hrs, she had 7-8/10 headache. Tylenol 1000mg PO taken. After 5 hours, she was very fatigued, headache 5/10. Fell asleep. Fever started during the night, when she woke up today 12/23/20 @ 6AM, it was 101.3 - she had a cold shower and had a headache of 5/10. She took tylenol 1000mg PO at 6:30AM. at 8:30AM, temp. is 99 degrees and headache gone.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, On and off phenomenon, Upper-airway cough syndrome, Vertigo
Clinical narrative: Staff from office called 12/23/20 to report that they had seen patient in the office for an adverse reaction to the Shingrix vaccination that patient had received on 12/20/20 at the pharmacy. Per staff, the patient developed symptoms in the middle of the night on 12/20. She woke up feeling dizzy and nauseated, almost as if she was having an episode of vertigo. Staff stated the patient is continuing to have dizzy spells on and off since 12/20. Patient is also having some post-nasal drip according to the office notes. I asked if patient was having an additional symptoms such as pain, discomfort, fever and staff indicated that the patient was not. She simply is feeling dizzy especially when changing positions.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Had headache, Temperature of 100.3 degrees F took Tylenol 650mg Temp down to 99.7 degrees F. Also experienced Nausea, No vomiting. 12/19 in the evening Temperature was 99.6F. Called Primary MD and advised to rest.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Pt reports feeling dizzy and lightheaded & flush about 30-45 mins after vaccination. Pt reports that flush feeling resolved after 30 min however the dizziness & lightheadedness persisted. Pt ate lunch and did not feel any better and reported s/s to staff v/s were taken and were stable. Pt was given water and brought to lay down for continued observation
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Flushing
Clinical narrative: Pt was seated and suddenly became flushed and reported a strange taste in her mouth. Vitals taken. BP 116/65, pulse 87, O2 99%. Pt given water and continued to observe. Pt reported feeling better.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Resolved. Treatment dugs:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatments dugs:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: had hives on back and L arm 1 inch medial to vaccine injection site; no lip or tongue edema, no wheezing or stridor Treatment dugs:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Frequent bowel movements, Headache, Immediate post-injection reaction, Injection site pain
Clinical narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving. Treatment dugs:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving. Treatment dugs:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: 25mg po Benadryl given per vo Dr. at 9:20a -- 9:45 symptoms completely resolved  Treatment dugs:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: I was told to contact you and let you know that I have been having flu like symptoms since my vaccine Monday afternoon at 3:45. Started yesterday with the headache, body aches and chills. I stayed the day yesterday but i will be leaving early today as I am not feeling any better. Treatment dugs:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Treatment dugs:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Pain, Rhinorrhoea
Clinical narrative: 12/16 - onset of fatigue and runny nose followed by headache and body aches. As of 12/23 he has a mild headache not requiring any medication for relief. He missed a day of work on 12/22. He did not seek medical attention. Treatment dugs:
Age: 77.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Antinuclear antibody negative, Joint swelling, Malaise, Myalgia, Peripheral swelling
Clinical narrative: LOW GRADE FEVER FOR 3 DAYS, HANDS AND ANKLES SWOLLEN FOR 1 WEEK, RASH ON FOREARMS
Age: 77.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: LOW GRADE FEVER FOR 3 DAYS, HANDS AND ANKLES SWOLLEN FOR 1 WEEK, RASH ON FOREARMS
Age: 77.0
Sex: F
Vaccine: FLUA4, UNK
Symptoms: Joint swelling, Peripheral swelling, Pyrexia, Rash
Clinical narrative: LOW GRADE FEVER FOR 3 DAYS, HANDS AND ANKLES SWOLLEN FOR 1 WEEK, RASH ON FOREARMS
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: received an undiluted dose of the product; basically feeling like she's been hit by a truck; This is a spontaneous report from a contactable physician (reporting for her cousin).    A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 18Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  There were no prior vaccinations (within 4 weeks) of the vaccine.  On 18Dec2020, the patient received an undiluted dose of the product and basically feeling like she's been hit by a truck, which were reported as being medically significant.  Clinical details were reported as follows: a nurse drew up the correct amount from the vial, but it was fully concentrated. Per the reporter, the patient is young and healthy.  Reporter stated that she will advise the patient to self-monitor for any side effects, besides basically feeling like she's been hit by a truck from her immune system response from the undiluted vaccine.  The outcome of the events was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Product preparation issue
Clinical narrative: received an undiluted dose of the product; basically feeling like she's been hit by a truck; This is a spontaneous report from a contactable physician (reporting for her cousin).    A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 18Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  There were no prior vaccinations (within 4 weeks) of the vaccine.  On 18Dec2020, the patient received an undiluted dose of the product and basically feeling like she's been hit by a truck, which were reported as being medically significant.  Clinical details were reported as follows: a nurse drew up the correct amount from the vial, but it was fully concentrated. Per the reporter, the patient is young and healthy.  Reporter stated that she will advise the patient to self-monitor for any side effects, besides basically feeling like she's been hit by a truck from her immune system response from the undiluted vaccine.  The outcome of the events was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Palpitations
Clinical narrative: started to feel a warmth in her chest and abdomen; She felt like her heart was racing; Developed chest pain; This is a spontaneous report from a contactable other HCP (healthcare professional). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EJ1685), intramuscularly in the left arm on 18Dec2020 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. Medical history included known allergies to apple, cantaloupe, peach, avocado and IV contrast dye; all from unspecified dates. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ongoing famotidine and salbutamol (ALBUTEROL HFA) as needed (PRN); both for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received hydromorphone (DILAUDID) and triamcinolone acetonide (KENALOG); both from unknown dates to unknown dates for unknown indications and experienced allergy. The patient also previously received diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid (TdaP) vaccine on an unknown date for immunization and experienced allergy. On 18Dec2020 at 15:45, the patient started to feel a warmth in her chest and abdomen, she felt like her heart was racing, and developed chest pain. It was reported that "patient started to feel a warmth in her chest and abdomen. She felt like her heart was racing. Developed chest pain. No shortness of breath or difficulty swallowing". It was unknown whether the patient received any treatment for the events. It was reported that the adverse events resulted in emergency room/department or urgent care visit. It was also reported that the events were non-serious and did not cause or prolong hospitalization. The clinical outcomes of the events started to feel a warmth in her chest and abdomen, she felt like her heart was racing and developed chest pain were all unknown. It was unknown whether the patient had been tested for COVID-19 since the vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Feeling hot, Palpitations
Clinical narrative: started to feel a warmth in her chest and abdomen; She felt like her heart was racing; Developed chest pain; This is a spontaneous report from a contactable other HCP (healthcare professional). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EJ1685), intramuscularly in the left arm on 18Dec2020 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 vaccination. Medical history included known allergies to apple, cantaloupe, peach, avocado and IV contrast dye; all from unspecified dates. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ongoing famotidine and salbutamol (ALBUTEROL HFA) as needed (PRN); both for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received hydromorphone (DILAUDID) and triamcinolone acetonide (KENALOG); both from unknown dates to unknown dates for unknown indications and experienced allergy. The patient also previously received diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid (TdaP) vaccine on an unknown date for immunization and experienced allergy. On 18Dec2020 at 15:45, the patient started to feel a warmth in her chest and abdomen, she felt like her heart was racing, and developed chest pain. It was reported that "patient started to feel a warmth in her chest and abdomen. She felt like her heart was racing. Developed chest pain. No shortness of breath or difficulty swallowing". It was unknown whether the patient received any treatment for the events. It was reported that the adverse events resulted in emergency room/department or urgent care visit. It was also reported that the events were non-serious and did not cause or prolong hospitalization. The clinical outcomes of the events started to feel a warmth in her chest and abdomen, she felt like her heart was racing and developed chest pain were all unknown. It was unknown whether the patient had been tested for COVID-19 since the vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Feeling hot, Oropharyngeal discomfort, Rash, Rash erythematous
Clinical narrative: At approximately 1.5 hours after the vaccine, I started to feel warm.; developed a red, blotchy rash on my chest, neck, abdomen, back, and arms; There was a fullness in my throat, but I was not short of breath; This is a spontaneous report from a contactable other health care professional.  A 47-year-old female patient received bnt162b2 (BNT162B2; lot number: EL0140, expiry date: unknown), via an unspecified route of administration arm left on 18Dec2020 08:45 at, single (Dose Number: 1) for immunization. Medical history includes: Allergies to medications, food, or other products: Seasonal allergies. The patient's concomitant medications were not reported. On 18Dec2020 10:30, At approximately 1.5 hours after the vaccine, the patient started to feel warm. But 2.5 hours, she noticed that she developed a red, blotchy rash on my chest, neck, abdomen, back, and arms. There was a fullness in my throat, but I was not short of breath. The patient was brought to the Emergency room/department or urgent care. Treatment was received: Benadryl 50 mg po(per oral), Decadron 10 mg IV, Pepcid IV. The outcome of the events was recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular, Skin warm
Clinical narrative: At approximately 1.5 hours after the vaccine, I started to feel warm.; developed a red, blotchy rash on my chest, neck, abdomen, back, and arms; There was a fullness in my throat, but I was not short of breath; This is a spontaneous report from a contactable other health care professional.  A 47-year-old female patient received bnt162b2 (BNT162B2; lot number: EL0140, expiry date: unknown), via an unspecified route of administration arm left on 18Dec2020 08:45 at, single (Dose Number: 1) for immunization. Medical history includes: Allergies to medications, food, or other products: Seasonal allergies. The patient's concomitant medications were not reported. On 18Dec2020 10:30, At approximately 1.5 hours after the vaccine, the patient started to feel warm. But 2.5 hours, she noticed that she developed a red, blotchy rash on my chest, neck, abdomen, back, and arms. There was a fullness in my throat, but I was not short of breath. The patient was brought to the Emergency room/department or urgent care. Treatment was received: Benadryl 50 mg po(per oral), Decadron 10 mg IV, Pepcid IV. The outcome of the events was recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Oropharyngeal discomfort, Rash, Rash erythematous, Rash macular
Clinical narrative: At approximately 1.5 hours after the vaccine, I started to feel warm.; developed a red, blotchy rash on my chest, neck, abdomen, back, and arms; There was a fullness in my throat, but I was not short of breath; This is a spontaneous report from a contactable other health care professional.  A 47-year-old female patient received bnt162b2 (BNT162B2; lot number: EL0140, expiry date: unknown), via an unspecified route of administration arm left on 18Dec2020 08:45 at, single (Dose Number: 1) for immunization. Medical history includes: Allergies to medications, food, or other products: Seasonal allergies. The patient's concomitant medications were not reported. On 18Dec2020 10:30, At approximately 1.5 hours after the vaccine, the patient started to feel warm. But 2.5 hours, she noticed that she developed a red, blotchy rash on my chest, neck, abdomen, back, and arms. There was a fullness in my throat, but I was not short of breath. The patient was brought to the Emergency room/department or urgent care. Treatment was received: Benadryl 50 mg po(per oral), Decadron 10 mg IV, Pepcid IV. The outcome of the events was recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash, Rash macular, Skin warm, Throat tightness
Clinical narrative: At approximately 1.5 hours after the vaccine, I started to feel warm.; developed a red, blotchy rash on my chest, neck, abdomen, back, and arms; There was a fullness in my throat, but I was not short of breath; This is a spontaneous report from a contactable other health care professional.  A 47-year-old female patient received bnt162b2 (BNT162B2; lot number: EL0140, expiry date: unknown), via an unspecified route of administration arm left on 18Dec2020 08:45 at, single (Dose Number: 1) for immunization. Medical history includes: Allergies to medications, food, or other products: Seasonal allergies. The patient's concomitant medications were not reported. On 18Dec2020 10:30, At approximately 1.5 hours after the vaccine, the patient started to feel warm. But 2.5 hours, she noticed that she developed a red, blotchy rash on my chest, neck, abdomen, back, and arms. There was a fullness in my throat, but I was not short of breath. The patient was brought to the Emergency room/department or urgent care. Treatment was received: Benadryl 50 mg po(per oral), Decadron 10 mg IV, Pepcid IV. The outcome of the events was recovered.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Oedema
Clinical narrative: Redness in cheeks, greater on (opposite side from injection) right cheek; Mild swelling on right cheek; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) (Manufacturer Pfizer-BionTech, lot# EJ1685), intramuscular in arm left, on 19Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history included type 1 diabetes mellitus and hypothyroidism both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not pregnant. Concomitant medications included insulin lispro (HUMALOG), levothyroxine (unknown manufacturer), ascorbic acid (VIT C), folic acid (unknown manufacturer), minerals nos, vitamins nos (PRENATAL VITAMINS)  dexamethasone (DECADRON), metoclopramide (REGLAN), ondansetron (ZOFRAN), propofol (unknown manufacturer), midazolam hydrochloride (VERSED)  fentanyl (unknown manufacturer). The patient experienced redness in cheeks, greater on (opposite side from injection) right cheek on 19Dec2020 at 12:30 PM with outcome of recovering and mild swelling on right cheek on 19Dec2020 at 12:30 PM with outcome of recovering. Therapeutic measures were taken as a result of the events which included Benadryl 25 mg oral. The events were considered non serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Redness in cheeks, greater on (opposite side from injection) right cheek; Mild swelling on right cheek; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) (Manufacturer Pfizer-BionTech, lot# EJ1685), intramuscular in arm left, on 19Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history included type 1 diabetes mellitus and hypothyroidism both from an unknown date and unknown if ongoing. The patient had no known allergies. The patient was not pregnant. Concomitant medications included insulin lispro (HUMALOG), levothyroxine (unknown manufacturer), ascorbic acid (VIT C), folic acid (unknown manufacturer), minerals nos, vitamins nos (PRENATAL VITAMINS)  dexamethasone (DECADRON), metoclopramide (REGLAN), ondansetron (ZOFRAN), propofol (unknown manufacturer), midazolam hydrochloride (VERSED)  fentanyl (unknown manufacturer). The patient experienced redness in cheeks, greater on (opposite side from injection) right cheek on 19Dec2020 at 12:30 PM with outcome of recovering and mild swelling on right cheek on 19Dec2020 at 12:30 PM with outcome of recovering. Therapeutic measures were taken as a result of the events which included Benadryl 25 mg oral. The events were considered non serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoscopy, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Chills; sweating; Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration); Diarrhea at 18 hours after administration; Injection site pain; Muscle aches; fatigue; severe nausea (no vomiting); mental fog (last about 4-6hrs); Within one minute: tachycardia (lasted about 3mins); dizziness (lasted 4-6hrs); weakness (lasted 12hours); This is a spontaneous report from a contactable consumer reported for herself.   A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 17Dec2020 at 19:30 via unspecified route of administration at the right arm in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient haven't known allergies. About 7 years ago the patient had received HPV vaccine on unknown date and she experienced reaction to excipient. Within one minute the patient experienced tachycardia (lasted about 3mins), mental fog (last about 4-6hrs), dizziness (lasted 4-6hrs), and weakness (lasted 12hours). Starting 15mins after vaccine, severe nausea (no vomiting) that last two hours. Muscle aches and fatigue started at two hours after vaccine administration. Injection site pain started 6hrs after administration. On 18Dec2020 chills and sweating. Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration). Due to fever, other symptoms, and recent exposure to COVID at place of employment, COVID nasal swab was done on 19Dec2020 at 1300 to rule out possible active diagnose. Test pending at this time. Tylenol administered to reduce fever and symptoms. Outcome of events at the time of last observation was reported as recovering.  Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Muscular weakness, Myalgia, Nausea, Pain
Clinical narrative: Chills; sweating; Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration); Diarrhea at 18 hours after administration; Injection site pain; Muscle aches; fatigue; severe nausea (no vomiting); mental fog (last about 4-6hrs); Within one minute: tachycardia (lasted about 3mins); dizziness (lasted 4-6hrs); weakness (lasted 12hours); This is a spontaneous report from a contactable consumer reported for herself.   A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 17Dec2020 at 19:30 via unspecified route of administration at the right arm in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient haven't known allergies. About 7 years ago the patient had received HPV vaccine on unknown date and she experienced reaction to excipient. Within one minute the patient experienced tachycardia (lasted about 3mins), mental fog (last about 4-6hrs), dizziness (lasted 4-6hrs), and weakness (lasted 12hours). Starting 15mins after vaccine, severe nausea (no vomiting) that last two hours. Muscle aches and fatigue started at two hours after vaccine administration. Injection site pain started 6hrs after administration. On 18Dec2020 chills and sweating. Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration). Due to fever, other symptoms, and recent exposure to COVID at place of employment, COVID nasal swab was done on 19Dec2020 at 1300 to rule out possible active diagnose. Test pending at this time. Tylenol administered to reduce fever and symptoms. Outcome of events at the time of last observation was reported as recovering.  Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tachycardia, Vomiting
Clinical narrative: Chills; sweating; Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration); Diarrhea at 18 hours after administration; Injection site pain; Muscle aches; fatigue; severe nausea (no vomiting); mental fog (last about 4-6hrs); Within one minute: tachycardia (lasted about 3mins); dizziness (lasted 4-6hrs); weakness (lasted 12hours); This is a spontaneous report from a contactable consumer reported for herself.   A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 17Dec2020 at 19:30 via unspecified route of administration at the right arm in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient haven't known allergies. About 7 years ago the patient had received HPV vaccine on unknown date and she experienced reaction to excipient. Within one minute the patient experienced tachycardia (lasted about 3mins), mental fog (last about 4-6hrs), dizziness (lasted 4-6hrs), and weakness (lasted 12hours). Starting 15mins after vaccine, severe nausea (no vomiting) that last two hours. Muscle aches and fatigue started at two hours after vaccine administration. Injection site pain started 6hrs after administration. On 18Dec2020 chills and sweating. Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration). Due to fever, other symptoms, and recent exposure to COVID at place of employment, COVID nasal swab was done on 19Dec2020 at 1300 to rule out possible active diagnose. Test pending at this time. Tylenol administered to reduce fever and symptoms. Outcome of events at the time of last observation was reported as recovering.  Information about lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Chills; sweating; Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration); Diarrhea at 18 hours after administration; Injection site pain; Muscle aches; fatigue; severe nausea (no vomiting); mental fog (last about 4-6hrs); Within one minute: tachycardia (lasted about 3mins); dizziness (lasted 4-6hrs); weakness (lasted 12hours); This is a spontaneous report from a contactable consumer reported for herself.   A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization on 17Dec2020 at 19:30 via unspecified route of administration at the right arm in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient haven't known allergies. About 7 years ago the patient had received HPV vaccine on unknown date and she experienced reaction to excipient. Within one minute the patient experienced tachycardia (lasted about 3mins), mental fog (last about 4-6hrs), dizziness (lasted 4-6hrs), and weakness (lasted 12hours). Starting 15mins after vaccine, severe nausea (no vomiting) that last two hours. Muscle aches and fatigue started at two hours after vaccine administration. Injection site pain started 6hrs after administration. On 18Dec2020 chills and sweating. Fever (99.1F) started at 22 hours and peaked at 99.9 (approximately 32 hours after vaccine administration). Due to fever, other symptoms, and recent exposure to COVID at place of employment, COVID nasal swab was done on 19Dec2020 at 1300 to rule out possible active diagnose. Test pending at this time. Tylenol administered to reduce fever and symptoms. Outcome of events at the time of last observation was reported as recovering.  Information about lot/batch number has been requested.