chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: Fatigue, lethargy, body aches, joint paint, headache, brain fog, nausea w/o vomiting
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: Fatigue, lethargy, body aches, joint paint, headache, brain fog, nausea w/o vomiting
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Heart rate increased, Urine analysis
Clinical narrative: Very high heart rate 110 for over 5 hours. Went to ER
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Malaise, Migraine
Clinical narrative: Severe joint pain, specifically excruciating pain in Left foot mostly in the heel area.   Could not put any weight on it by next morning to even make it to the bathroom,  very bad migraine for 5 days, arm pain that was a lot worse than what i had heard about, feeling not well and very very low energy and feeling unwell, which is still going on.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe joint pain, specifically excruciating pain in Left foot mostly in the heel area.   Could not put any weight on it by next morning to even make it to the bathroom,  very bad migraine for 5 days, arm pain that was a lot worse than what i had heard about, feeling not well and very very low energy and feeling unwell, which is still going on.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain in extremity
Clinical narrative: SORE ARM. NAUSEA  HEAD ACHE(FELT LIKE A SINUS PROBLEM) UNUSUAL SHARP PAINS IN SEVERAL JOINTS    ALL FOR ABOUT 36 HOURS
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Quarter size Herpes zoster rash on left buttock. Itchy,  pain, bumpy. Have had shingles many times in the past. Received  Zostavax vaccine in 2017.  Started Acyclovir 400 mg 5 times a day
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling hot, Hyperhidrosis
Clinical narrative: Twenty minutes after injection broke out in a sweat from head to toe.  Vitals were only slightly elevated.    Continued with bouts or waves of warmth for 2weeks.  Also feel anxiety in my chest that continues
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Musculoskeletal stiffness, Oral herpes
Clinical narrative: several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, stiff, not painful joints, tiredness, and (the most unusual) is an elevation of my blood glucose to at and above 180 for about 24 hours (I have used a continuous glucose monitor for the past 7 months and have learned food/body responses and usually drop into the 120 range over night. i have daily graphs for the time represented here). No treatment except caution on food and continued regular medications, outcome. All these symptoms stopped about 48 hours later on Saturday, Jan 30, 2021.  I am reporting for information only regarding this new vaccine.  I intend to take my second, booster dose in the regular 3 week interval.  Did not consult physician nor clinic.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Injection site was red and began itching on the morning of the 8th day after vaccination.  By end of day it was red, swollen, hot, sore, and a large hard lump 3.5 " in diameter.   Went to urgent care clinic the following morning (today, Day 9 after injection).  I was told it was a local hypersensitivity reaction, no cellulitis.  I was told to take histamine blockers both Allegra and Pepcid, use hydrocortisone cream for the itching, apply ice, and use ibuprofen or acetaminophen as needed for soreness.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red and began itching on the morning of the 8th day after vaccination.  By end of day it was red, swollen, hot, sore, and a large hard lump 3.5 " in diameter.   Went to urgent care clinic the following morning (today, Day 9 after injection).  I was told it was a local hypersensitivity reaction, no cellulitis.  I was told to take histamine blockers both Allegra and Pepcid, use hydrocortisone cream for the itching, apply ice, and use ibuprofen or acetaminophen as needed for soreness.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea (Six or more loose stools in 24 hours)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site urticaria, Pruritus
Clinical narrative: During the night the arm itched. During the morning started to develop hives in the area where the vaccine was placed, becoming a rush around the injection site.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site rash, Pain
Clinical narrative: Restless night of sleep, woke up with massive head and body aches.  Pain at injection site. Took otc pain relievers and continued the day. Midday aches came back with fatigue.  Next day, bodyaches and headache are gone. But a rash has developed at injection site. This was shot #2 of moderna. Shot one I only experienced pain at injection site
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: Restless night of sleep, woke up with massive head and body aches.  Pain at injection site. Took otc pain relievers and continued the day. Midday aches came back with fatigue.  Next day, bodyaches and headache are gone. But a rash has developed at injection site. This was shot #2 of moderna. Shot one I only experienced pain at injection site
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: developed swollen upper lip 15 minutes after receiving COVID-19 vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Chills, low grade fever 100.5 and tachycardia, hr increased to 131 while standing
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness x 3cm, itching, mild tenderness at injection site. Recommend Zyrtec 10mg. daily, take medrol dose pak if symptoms worsen in 24-48hrs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Pain in extremity, Post-acute COVID-19 syndrome, Rash erythematous
Clinical narrative: "covid arm": red rash on arm where shot occured, ten days later (also 3 days sore arm starting day after shot)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Myalgia, Pyrexia
Clinical narrative: Dizziness, Myalgia, Fever & Diarrhea Narrative:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache & Fever Narrative:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia
Clinical narrative: Myalgia, Arthralgia, Fever, WEAKNESS Narrative:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: REDNESS, ITCHING INDURATION AT INJECTION SITE Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Vertigo, Vomiting
Clinical narrative: Headache, NauseaVomiting, VERTIGO, MIGRAINE Narrative:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Vomiting
Clinical narrative: Headache, Arthralgia & NauseaVomiting Narrative:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, LOSS OF SMELL AND TASTE-RESOLVED Narrative:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Headache, Myalgia, Fever, chills, rhinorrhea, sore throat, chills, fatigue Narrative:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Headache, Myalgia, Fever, chills, rhinorrhea, sore throat, chills, fatigue Narrative:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Dizziness, Headache, Myalgia, Fever & NauseaVomiting Narrative:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, Headache, Myalgia, Fever & NauseaVomiting Narrative:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypogeusia, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia, Fever, DIMINISHED TASTE-RESOLVED Narrative:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, Fever, cough, rhinorrhea, fatigue, chills Narrative:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Headache, Myalgia, Fever, cough, rhinorrhea, fatigue, chills Narrative:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Arthralgia & Fever Narrative:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash macular, SARS-CoV-2 test
Clinical narrative: pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally/cheeks/chin, forehead, ears, nose. Neck and chest spared/unilateral rash (left side)/Rash was red, splotchy in appearance, and flat; textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally; deeper, maroon discoloration; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at right arm on 16Dec2020 08:15 AM at single dose for COVID-19 immunization. Medical history included depression, ADHD and known allergies: wasp venom (local swelling and redness). Concomitant drugs included methylphenidate hydrochloride (CONCERTA XL), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), and unspecified multivitamin. No other vaccine in four weeks. Historical vaccine included measles vaccine; mumps vaccine; rubella vaccine (MMR VACCIN) for immunization (allergies: local swelling and redness). Patient was not pregnant. No Covid prior vaccination. On 19Dec2020, patient experienced pruritic, textured rash with redness and warmth on the face bilaterally. Most noticeable on cheeks which at times have had deeper, maroon discoloration. Rash also presented on chin, forehead, ears, and nose. Neck and chest spared. Rash recurred daily. It worsened after a warm shower. Additionally, a unilateral rash (left side) was observed for a few minutes on torso and leg after a warm shower 3 days after vaccine. Rash was red, splotchy in appearance, and flat, resolved within minutes (as reported). Right torso and leg were unaffected. No known changes in skin care routine, regular medication or supplements, exposures, chemicals, or contact. No prior history of rashes described. The local injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising. It was reported events resulted in doctor or other healthcare professional office/clinic visit. Treatments Pepcid, ibuprofen (steroid script was not filled) were received for events. Patient had nasal swab/ nasopharyngeal PCR of covid test on 17Dec2020: negative and on 21Dec2020: negative. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally/cheeks/chin, forehead, ears, nose. Neck and chest spared/unilateral rash (left side)/Rash was red, splotchy in appearance, and flat; textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally; deeper, maroon discoloration; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at right arm on 16Dec2020 08:15 AM at single dose for COVID-19 immunization. Medical history included depression, ADHD and known allergies: wasp venom (local swelling and redness). Concomitant drugs included methylphenidate hydrochloride (CONCERTA XL), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), and unspecified multivitamin. No other vaccine in four weeks. Historical vaccine included measles vaccine; mumps vaccine; rubella vaccine (MMR VACCIN) for immunization (allergies: local swelling and redness). Patient was not pregnant. No Covid prior vaccination. On 19Dec2020, patient experienced pruritic, textured rash with redness and warmth on the face bilaterally. Most noticeable on cheeks which at times have had deeper, maroon discoloration. Rash also presented on chin, forehead, ears, and nose. Neck and chest spared. Rash recurred daily. It worsened after a warm shower. Additionally, a unilateral rash (left side) was observed for a few minutes on torso and leg after a warm shower 3 days after vaccine. Rash was red, splotchy in appearance, and flat, resolved within minutes (as reported). Right torso and leg were unaffected. No known changes in skin care routine, regular medication or supplements, exposures, chemicals, or contact. No prior history of rashes described. The local injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising. It was reported events resulted in doctor or other healthcare professional office/clinic visit. Treatments Pepcid, ibuprofen (steroid script was not filled) were received for events. Patient had nasal swab/ nasopharyngeal PCR of covid test on 17Dec2020: negative and on 21Dec2020: negative. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Injection site pain, Pain, Rash macular
Clinical narrative: pain around injection site; pain in left side of body to waist; pain in the muscle of the left underarm; red and blotchy upper arm; blotchy upper arm; This case was reported by a consumer and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd December 2020, 1 days after receiving Shingrix, the patient experienced injection site pain, generalized aching, axillary pain, erythema of extremities and blotchy. On an unknown date, the outcome of the injection site pain, generalized aching, axillary pain, erythema of extremities and blotchy were recovered/resolved.   It was unknown if the reporter considered the injection site pain, generalized aching, axillary pain, erythema of extremities and blotchy to be related to Shingrix.  Additional details were provided as follows: The patient reported herself. The patient reported the day after receiving the vaccine she had pain around the injection site, her left arm was red and blotchy around the whole upper arm, pain in the muscle of the left underarm, and pain in the left side almost down to the waist area. The patient reported these events lasted about 10 days and have resolved.  The reporter did not have batch number and expiry date information. The reporter consented to follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, C-reactive protein normal, CSF culture negative, Computerised tomogram head normal
Clinical narrative: Received influenza vaccination 12/7, 2-3 days later noted tingling in feet, progressing to B calf pain. Received COVID vaccination 12/23. Noticed weakness, trouble walking and weakness in hands.  Presented to ED 12/24, afebrile and stable VS. Admitted to Hospital with consult to neurology. IVIG started 12/25; given 5 doses by 12/29. WBC decreased on 12/26.  B12 on 12/27 low at 64, so started on B12 IV 12/28. EMG 12/28 was nonspecific patchy neuropathy, not diagnostic but consistent with GBS. Urinary hesitancy/retention better 12/29. Undergoing PT and OT.  Able to walk without walker 12/29, but still needs extensive rehab so discharge to acute rehab.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture normal
Clinical narrative: Received influenza vaccination 12/7, 2-3 days later noted tingling in feet, progressing to B calf pain. Received COVID vaccination 12/23. Noticed weakness, trouble walking and weakness in hands.  Presented to ED 12/24, afebrile and stable VS. Admitted to Hospital with consult to neurology. IVIG started 12/25; given 5 doses by 12/29. WBC decreased on 12/26.  B12 on 12/27 low at 64, so started on B12 IV 12/28. EMG 12/28 was nonspecific patchy neuropathy, not diagnostic but consistent with GBS. Urinary hesitancy/retention better 12/29. Undergoing PT and OT.  Able to walk without walker 12/29, but still needs extensive rehab so discharge to acute rehab.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal normal, Muscular weakness, Neuropathy peripheral, Pain in extremity
Clinical narrative: Received influenza vaccination 12/7, 2-3 days later noted tingling in feet, progressing to B calf pain. Received COVID vaccination 12/23. Noticed weakness, trouble walking and weakness in hands.  Presented to ED 12/24, afebrile and stable VS. Admitted to Hospital with consult to neurology. IVIG started 12/25; given 5 doses by 12/29. WBC decreased on 12/26.  B12 on 12/27 low at 64, so started on B12 IV 12/28. EMG 12/28 was nonspecific patchy neuropathy, not diagnostic but consistent with GBS. Urinary hesitancy/retention better 12/29. Undergoing PT and OT.  Able to walk without walker 12/29, but still needs extensive rehab so discharge to acute rehab.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test negative, Seizure, Urinary hesitation, Urinary retention
Clinical narrative: Received influenza vaccination 12/7, 2-3 days later noted tingling in feet, progressing to B calf pain. Received COVID vaccination 12/23. Noticed weakness, trouble walking and weakness in hands.  Presented to ED 12/24, afebrile and stable VS. Admitted to Hospital with consult to neurology. IVIG started 12/25; given 5 doses by 12/29. WBC decreased on 12/26.  B12 on 12/27 low at 64, so started on B12 IV 12/28. EMG 12/28 was nonspecific patchy neuropathy, not diagnostic but consistent with GBS. Urinary hesitancy/retention better 12/29. Undergoing PT and OT.  Able to walk without walker 12/29, but still needs extensive rehab so discharge to acute rehab.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin B12 decreased, White blood cell count decreased, White matter lesion
Clinical narrative: Received influenza vaccination 12/7, 2-3 days later noted tingling in feet, progressing to B calf pain. Received COVID vaccination 12/23. Noticed weakness, trouble walking and weakness in hands.  Presented to ED 12/24, afebrile and stable VS. Admitted to Hospital with consult to neurology. IVIG started 12/25; given 5 doses by 12/29. WBC decreased on 12/26.  B12 on 12/27 low at 64, so started on B12 IV 12/28. EMG 12/28 was nonspecific patchy neuropathy, not diagnostic but consistent with GBS. Urinary hesitancy/retention better 12/29. Undergoing PT and OT.  Able to walk without walker 12/29, but still needs extensive rehab so discharge to acute rehab.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: hive rash on her body; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no history of allergies. The patient reported on unspecified date, six days after receiving a dose of the covid vaccine, she developed hive rash on her body requiring steroids to treat. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hive rash on her body; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no history of allergies. The patient reported on unspecified date, six days after receiving a dose of the covid vaccine, she developed hive rash on her body requiring steroids to treat. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: 1/3/2021 Vaccination at 2:30. 11 minutes later, experienced throat scratchy; felt 'full'. Constant cough. Took over to EMT's. 25 Benadryl. Resolved within 40 minutes. Felt better after.  1/26 telehealth with allergist. Epi pen prescribed.  *Have plan with Primary and allergist; xyzal taken before., during and after.  Going to give IV fluids, observation with 2nd dose.   2/1/2021 @ 12 for second dose
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache, Hypoaesthesia, Hypoaesthesia oral, Neck pain
Clinical narrative: Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment  at the ER where she received prednisone and valacyclovir for one week treatment.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment  at the ER where she received prednisone and valacyclovir for one week treatment.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hypoaesthesia oral, Mouth swelling
Clinical narrative: Patient started she had numbness to tongue area and HA to frontal lobe. Taste to food was different and the continues of HA and numbness sensation during the day/ evening. She was unable to close her R eyelid and R side drooping. The HA increased with time after two weeks the R side of the face different mouth and R side was swollen. She then seek medical treatment  at the ER where she received prednisone and valacyclovir for one week treatment.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Supraventricular extrasystoles, Vaccine positive rechallenge
Clinical narrative: Since getting first shot and again after the second shot, have had frequent afib/apc's; Since getting first shot and again after the second shot, have had frequent afib/apc's; This is a spontaneous report from a contactable Physician (ophthalmologist) reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: eh9899), intramuscular on 21Dec2020 at 15:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was not receiving concomitant medications. Medical history included ongoing paroxysmal afib (atrial fibrillation). The patient has known allergies to squid. The patient reported having a long history of paroxysmal afib, very fit, play tennis at the national level. Prior to vaccine have had 2-3 brief bouts of afib/year. Since getting first shot and again after the second shot, have had frequent afib/apc's (atrial premature contractions) at least 6 episodes. Adverse event start date was reported as 21Dec2020 at 02:00 AM (pending clarification). No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: The event is considered possibly related to the suspect product based on the reportedly positive temporal association in a subject with a positive medical history of atrial arrhythmias. 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: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Supraventricular extrasystoles
Clinical narrative: Since getting first shot and again after the second shot, have had frequent afib/apc's; Since getting first shot and again after the second shot, have had frequent afib/apc's; This is a spontaneous report from a contactable Physician (ophthalmologist) reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: eh9899), intramuscular on 21Dec2020 at 15:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 65 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was not receiving concomitant medications. Medical history included ongoing paroxysmal afib (atrial fibrillation). The patient has known allergies to squid. The patient reported having a long history of paroxysmal afib, very fit, play tennis at the national level. Prior to vaccine have had 2-3 brief bouts of afib/year. Since getting first shot and again after the second shot, have had frequent afib/apc's (atrial premature contractions) at least 6 episodes. Adverse event start date was reported as 21Dec2020 at 02:00 AM (pending clarification). No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The outcome of the event was unknown.; Sender's Comments: The event is considered possibly related to the suspect product based on the reportedly positive temporal association in a subject with a positive medical history of atrial arrhythmias. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: 1/4/2021 within 5 minutes of having vaccine, I was SOB. Took mask off, I could not breathe. Light headed, fuzzy feeling. Vitals; BP was elevated but not too much. Lips tingling, throat was itchy, both calves tingling. Help walking to ER. Epi shot. As wore off, my chin was numb, tongue was numb, 2nd epi shot. 2.5 hours in ER for observation.  Pale. Legs felt like jelly.   *COVID +  OCT 19th 2020, OCT 22nd test came back positive . Only 1 bad day. Otherwise, mild symptoms.  *Informed cant have the COVID 19 2nd vaccine *react to flu shots / haven't had for 20 years
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, COVID-19, Dizziness, Dyspnoea
Clinical narrative: 1/4/2021 within 5 minutes of having vaccine, I was SOB. Took mask off, I could not breathe. Light headed, fuzzy feeling. Vitals; BP was elevated but not too much. Lips tingling, throat was itchy, both calves tingling. Help walking to ER. Epi shot. As wore off, my chin was numb, tongue was numb, 2nd epi shot. 2.5 hours in ER for observation.  Pale. Legs felt like jelly.   *COVID +  OCT 19th 2020, OCT 22nd test came back positive . Only 1 bad day. Otherwise, mild symptoms.  *Informed cant have the COVID 19 2nd vaccine *react to flu shots / haven't had for 20 years
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Muscular weakness, Pallor
Clinical narrative: 1/4/2021 within 5 minutes of having vaccine, I was SOB. Took mask off, I could not breathe. Light headed, fuzzy feeling. Vitals; BP was elevated but not too much. Lips tingling, throat was itchy, both calves tingling. Help walking to ER. Epi shot. As wore off, my chin was numb, tongue was numb, 2nd epi shot. 2.5 hours in ER for observation.  Pale. Legs felt like jelly.   *COVID +  OCT 19th 2020, OCT 22nd test came back positive . Only 1 bad day. Otherwise, mild symptoms.  *Informed cant have the COVID 19 2nd vaccine *react to flu shots / haven't had for 20 years
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Throat irritation
Clinical narrative: 1/4/2021 within 5 minutes of having vaccine, I was SOB. Took mask off, I could not breathe. Light headed, fuzzy feeling. Vitals; BP was elevated but not too much. Lips tingling, throat was itchy, both calves tingling. Help walking to ER. Epi shot. As wore off, my chin was numb, tongue was numb, 2nd epi shot. 2.5 hours in ER for observation.  Pale. Legs felt like jelly.   *COVID +  OCT 19th 2020, OCT 22nd test came back positive . Only 1 bad day. Otherwise, mild symptoms.  *Informed cant have the COVID 19 2nd vaccine *react to flu shots / haven't had for 20 years
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Myalgia, Myocarditis, Pyrexia
Clinical narrative: I was the patients' ER physician. After getting the second dose of the COVID vaccine the patient developed chest pain within 24 hours. When I met him 3 days after the 2nd vaccine, I diagnosed him with pericarditis. His troponin was 18.8, and he required admission to the hospital.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: I was the patients' ER physician. After getting the second dose of the COVID vaccine the patient developed chest pain within 24 hours. When I met him 3 days after the 2nd vaccine, I diagnosed him with pericarditis. His troponin was 18.8, and he required admission to the hospital.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pericarditis, Troponin increased
Clinical narrative: I was the patients' ER physician. After getting the second dose of the COVID vaccine the patient developed chest pain within 24 hours. When I met him 3 days after the 2nd vaccine, I diagnosed him with pericarditis. His troponin was 18.8, and he required admission to the hospital.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Nausea, Sensation of foreign body
Clinical narrative: Reports some nausea and dizziness 20 minutes after injection that resolved quickly. Approximately 12 hours later awoke and experienced difficulty swallowing but no respiratory difficulty. Went to ER and received steroids and monitoring for 1-2 hours.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Nausea
Clinical narrative: Reports some nausea and dizziness 20 minutes after injection that resolved quickly. Approximately 12 hours later awoke and experienced difficulty swallowing but no respiratory difficulty. Went to ER and received steroids and monitoring for 1-2 hours.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electric shock sensation, Immediate post-injection reaction, Palpitations, Throat irritation
Clinical narrative: Tightening of throat, SOB for 1o minutes
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Tightening of throat, SOB for 1o minutes
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Tightening of throat, SOB for 1o minutes
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Shaky, throat felt different, felt hear beat fast and then not
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Heart rate irregular, Oropharyngeal discomfort, Tremor
Clinical narrative: Shaky, throat felt different, felt hear beat fast and then not
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cold sweat, Dysphagia, Hyperhidrosis, Swelling face, Throat tightness
Clinical narrative: Anaphylaxis; Abnormal: tryptase elevated; This is a spontaneous report from a contactable nurse (patient) and another contactable nurse. A 42-year-old female patient received 1st dose of BNT162B2, via Intramuscular in deltoid left on 14Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included anxiety, anti-phospholipid antibody syndrome. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), warfarin sodium (CUMADIN) and Multivitamin. Prior Vaccinations (within 4 weeks) was none. Within 10 minutes (7-8 minutes) of receiving the vaccine, she began to experience swelling in throat, red rash on chest, anxiety, clammy skin, sweating, and lip and eye swelling. She notified staff and was given 50 mg of Benadryl and an epi pen. she ended up in the emergency department for additional treatment for diagnosed as anaphylaxis. Detailed clinical course: first her throat was closing then she went to Emergency Room where her lips and eyes started swelling and got worse. 50 mg Benadryl IM with no effect, then she was administered Epipen then IV fluids IV Steroid. She had no history of anaphylaxis or allergies. She thought the manufacture should be aware of this serious event. There was a causal relationship between the event and BNT162B2. No hospitalization/surgery required. On 14Jan2021, some lab tests where performed: Blood count all normal, tryptasa abnormal elevated. On 15Jan2021, she had a secondary reaction, the anaphylaxis happened again she ended up in the hospital. At home she took 50 mg Benadryl Oral and Epipen. Then went to emergency room where she was administered more Steroids. 4 hours under observation. In 15Jan2021 she also had tongue swelling. The outcome of event anaphylaxis was recovered on an unspecified date of Jan2021, for tryptase increased was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event anaphylactic reaction and  BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Blood count normal, Cold sweat, Eye swelling
Clinical narrative: Anaphylaxis; Abnormal: tryptase elevated; This is a spontaneous report from a contactable nurse (patient) and another contactable nurse. A 42-year-old female patient received 1st dose of BNT162B2, via Intramuscular in deltoid left on 14Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included anxiety, anti-phospholipid antibody syndrome. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), warfarin sodium (CUMADIN) and Multivitamin. Prior Vaccinations (within 4 weeks) was none. Within 10 minutes (7-8 minutes) of receiving the vaccine, she began to experience swelling in throat, red rash on chest, anxiety, clammy skin, sweating, and lip and eye swelling. She notified staff and was given 50 mg of Benadryl and an epi pen. she ended up in the emergency department for additional treatment for diagnosed as anaphylaxis. Detailed clinical course: first her throat was closing then she went to Emergency Room where her lips and eyes started swelling and got worse. 50 mg Benadryl IM with no effect, then she was administered Epipen then IV fluids IV Steroid. She had no history of anaphylaxis or allergies. She thought the manufacture should be aware of this serious event. There was a causal relationship between the event and BNT162B2. No hospitalization/surgery required. On 14Jan2021, some lab tests where performed: Blood count all normal, tryptasa abnormal elevated. On 15Jan2021, she had a secondary reaction, the anaphylaxis happened again she ended up in the hospital. At home she took 50 mg Benadryl Oral and Epipen. Then went to emergency room where she was administered more Steroids. 4 hours under observation. In 15Jan2021 she also had tongue swelling. The outcome of event anaphylaxis was recovered on an unspecified date of Jan2021, for tryptase increased was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event anaphylactic reaction and  BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Lip swelling, Pharyngeal swelling, Rash, Rash erythematous
Clinical narrative: Anaphylaxis; Abnormal: tryptase elevated; This is a spontaneous report from a contactable nurse (patient) and another contactable nurse. A 42-year-old female patient received 1st dose of BNT162B2, via Intramuscular in deltoid left on 14Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included anxiety, anti-phospholipid antibody syndrome. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), warfarin sodium (CUMADIN) and Multivitamin. Prior Vaccinations (within 4 weeks) was none. Within 10 minutes (7-8 minutes) of receiving the vaccine, she began to experience swelling in throat, red rash on chest, anxiety, clammy skin, sweating, and lip and eye swelling. She notified staff and was given 50 mg of Benadryl and an epi pen. she ended up in the emergency department for additional treatment for diagnosed as anaphylaxis. Detailed clinical course: first her throat was closing then she went to Emergency Room where her lips and eyes started swelling and got worse. 50 mg Benadryl IM with no effect, then she was administered Epipen then IV fluids IV Steroid. She had no history of anaphylaxis or allergies. She thought the manufacture should be aware of this serious event. There was a causal relationship between the event and BNT162B2. No hospitalization/surgery required. On 14Jan2021, some lab tests where performed: Blood count all normal, tryptasa abnormal elevated. On 15Jan2021, she had a secondary reaction, the anaphylaxis happened again she ended up in the hospital. At home she took 50 mg Benadryl Oral and Epipen. Then went to emergency room where she was administered more Steroids. 4 hours under observation. In 15Jan2021 she also had tongue swelling. The outcome of event anaphylaxis was recovered on an unspecified date of Jan2021, for tryptase increased was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event anaphylactic reaction and  BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat tightness, Tryptase increased
Clinical narrative: Anaphylaxis; Abnormal: tryptase elevated; This is a spontaneous report from a contactable nurse (patient) and another contactable nurse. A 42-year-old female patient received 1st dose of BNT162B2, via Intramuscular in deltoid left on 14Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included anxiety, anti-phospholipid antibody syndrome. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), warfarin sodium (CUMADIN) and Multivitamin. Prior Vaccinations (within 4 weeks) was none. Within 10 minutes (7-8 minutes) of receiving the vaccine, she began to experience swelling in throat, red rash on chest, anxiety, clammy skin, sweating, and lip and eye swelling. She notified staff and was given 50 mg of Benadryl and an epi pen. she ended up in the emergency department for additional treatment for diagnosed as anaphylaxis. Detailed clinical course: first her throat was closing then she went to Emergency Room where her lips and eyes started swelling and got worse. 50 mg Benadryl IM with no effect, then she was administered Epipen then IV fluids IV Steroid. She had no history of anaphylaxis or allergies. She thought the manufacture should be aware of this serious event. There was a causal relationship between the event and BNT162B2. No hospitalization/surgery required. On 14Jan2021, some lab tests where performed: Blood count all normal, tryptasa abnormal elevated. On 15Jan2021, she had a secondary reaction, the anaphylaxis happened again she ended up in the hospital. At home she took 50 mg Benadryl Oral and Epipen. Then went to emergency room where she was administered more Steroids. 4 hours under observation. In 15Jan2021 she also had tongue swelling. The outcome of event anaphylaxis was recovered on an unspecified date of Jan2021, for tryptase increased was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event anaphylactic reaction and  BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cold sweat, Cough, Dysphagia, Erythema
Clinical narrative: Anaphylaxis; Abnormal: tryptase elevated; This is a spontaneous report from a contactable nurse (patient) and another contactable nurse. A 42-year-old female patient received 1st dose of BNT162B2, via Intramuscular in deltoid left on 14Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included anxiety, anti-phospholipid antibody syndrome. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), warfarin sodium (CUMADIN) and Multivitamin. Prior Vaccinations (within 4 weeks) was none. Within 10 minutes (7-8 minutes) of receiving the vaccine, she began to experience swelling in throat, red rash on chest, anxiety, clammy skin, sweating, and lip and eye swelling. She notified staff and was given 50 mg of Benadryl and an epi pen. she ended up in the emergency department for additional treatment for diagnosed as anaphylaxis. Detailed clinical course: first her throat was closing then she went to Emergency Room where her lips and eyes started swelling and got worse. 50 mg Benadryl IM with no effect, then she was administered Epipen then IV fluids IV Steroid. She had no history of anaphylaxis or allergies. She thought the manufacture should be aware of this serious event. There was a causal relationship between the event and BNT162B2. No hospitalization/surgery required. On 14Jan2021, some lab tests where performed: Blood count all normal, tryptasa abnormal elevated. On 15Jan2021, she had a secondary reaction, the anaphylaxis happened again she ended up in the hospital. At home she took 50 mg Benadryl Oral and Epipen. Then went to emergency room where she was administered more Steroids. 4 hours under observation. In 15Jan2021 she also had tongue swelling. The outcome of event anaphylaxis was recovered on an unspecified date of Jan2021, for tryptase increased was unknown.  information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event anaphylactic reaction and  BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.