chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUA4
Symptoms: Muscular weakness, SARS-CoV-2 test negative, Tremor, White blood cell count increased
Clinical narrative: High white blood cell (WBC) 18,000; Hand shaking uncontrollable; Inside felt like jelly; Headache; Weakness legs heavy; This spontaneous case from the was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number 892918-1), reported by other health professional and concerned a female patient of an unspecified age.  The patient's concurrent conditions included high blood pressure (BP), hyper cholesterol and hypertension. The patient's concomitant medications included lisinopril, atenolol, Norvasc (amlodipine besilate) and fish oil, all for unreported indications.  On 07-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; route of administration: intramuscular, anatomical location: right arm, dose reported as 'one', indication: not reported). The batch number reported was 279782.  On 10-Oct-2020, three days after receiving Fluad Quadrivalent, the patient experienced severe headache, severe weakness legs heavy and hand shaking uncontrollable. The patient felt like jelly inside.  On 11-Oct-2020, four days after receiving Fluad Quadrivalent, the patient went to urgent care and then was sent to emergency room (ER). Labs, imaging and additional tests were completed. Chest x-ray, complete blood count (CBC) and electrocardiogram (EKG) were performed but with no results provided. Covid test revealed negative results. White blood cell count revealed high results of 18,000.  On 15-Oct-2020, the patient recovered from the events of headache, 'lower extremities weakness of' and 'shaking of hands'.  On an unspecified date in Oct-2020, the patient recovered from the events of 'feeling abnormal' and 'white blood cell count high'.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A female patient experienced muscular weakness, white blood cell count increased, tremor, feeling abnormal and headache in the days after administration of Fluad Quadrivalent. In the end, the patient recovered from all events. Covid test revealed negative results. Causality is assessed as possibly related for all events, but also confounded with reported concomitant drugs.; Sender's Comments: A female patient experienced muscular weakness, white blood cell count increased, tremor, feeling abnormal and headache in the days after administration of Fluad Quadrivalent. In the end, the patient recovered from all events. Covid test revealed negative results. Causality is assessed as possibly related for all events, but also confounded with reported concomitant drugs.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Oropharyngeal discomfort, Pharyngeal swelling
Clinical narrative: Throat felt weird, swollen; Throat felt weird, swollen; This spontaneous case from the  was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 893502-1), reported by other non-health professional (consumer) and concerned a 51-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: reported as one, anatomical location, route of administration and indication: not reported). The batch number reported was P100240252.  On the same date, within minutes after receiving Afluria Quadrivalent, the patient's back of his throat felt weird and swollen. It was not getting worse so the patient guessed that he would not worry about it. The nurses from clinic did not have an Epi Pen (epinephrine) or Benedryl (diphenhydramine hydrochloride). The patient refused an ambulance and they monitored him for over 20 minutes. Later, the patient was talking and laughing with them and the swelling was going down. His primary care physician (PCP) was notified. The patient was suggested to take Benadryl at home and was notified by nurses at site and his PCP by phone to pull over if difficulty breathing starts and call 911. He seemed to be ok at that time.  On the same date, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 51-year-old male patient developed pharyngeal swelling and oropharyngeal discomfort within minutes after vaccination with the suspect product, Afluria Quadrivalent. Information regarding the underlying medical history and concomitant medications have not been provided. Due to suggestive time relationship, causality for both events is assessed as possibly related.; Sender's Comments: A 51-year-old male patient developed Pharyngeal swelling and Oropharyngeal discomfort within minutes after vaccination with the suspect product, Afluria Quadrivalent. Information regarding the underlying medical history and concomitant medications have not been provided. Due to suggestive time relationship, causality for both events is assessed as possibly related.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Bursitis, Joint range of motion decreased, Pain in extremity
Clinical narrative: Bursitis; Felt like it was very challenging to raise her arm above her head (specifically in the joint); Arm was sore; Complaining of joint pain; This spontaneous case was retrieved on 21-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 894512-1) with additional information received on 14-Jan-2021 from Seqirus' manufacturing quality assurance department (being processed together), reported by other health professional and concerned a 73-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies.  On 02-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, anatomical location: left arm, route of administration: intramuscular, dose: reported as one and indication: not reported). The batch number reported was 290706.  On the same date, after receiving Fluad Quadrivalent, the patient was complaining of joint pain. The patient's arm was sore, and she felt like it was very challenging to raise her arm above her head (specifically in the joint). The patient was advised to try to see if Tylenol (paracetamol) would help relieve her pain.   On 03-Nov-2020, the patient said that pain had improved but her joint was still sore. The patient was concerned about bursitis. She was advised to reach out to primary care provider if it did not heal within three to five days.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 73-year-old female patient experienced bursitis, joint range of motion decreased, pain in extremity and arthralgia after administration of Fluad Quadrivalent. Causality is assessed as possibly related for all events due to suggestive chronology and lack of confounding factors.; Sender's Comments: A 73-year-old female patient experienced bursitis, joint range of motion decreased, pain in extremity and arthralgia after administration of Fluad Quadrivalent. Causality is assessed as possibly related for all events due to suggestive chronology and lack of confounding factors.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, Urticaria
Clinical narrative: Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm.  Patient advised vaccination team of previous allergic reactions to H1N1 vaccine (anaphlyxis - swelling of mouth, lips and tongue) and flu vaccine (head to toe hives).  Patient was counseled by lead pharmacist regarding risk and and data related to vaccine.  Patient agreed to receive vaccine.  Informed patient that we would monitor for potential reaction for 30 minutes, patient agreed to stay.  Patient was observed by nursing.  At approximately, 1850 patient reported that she felt her lips swelling, and noted to have difficulty in her speech.  She has administered 50mg Benadryl suspension.  Vital signs taken:  1900:  147/92; 82; 97% room air 1905:  132/101; 84; 97% room air 1910:  145/104; 84; 97% room air.   1915:  147/104; 81; 97% room air   RN observer called vaccine physician on call at 1915 regarding patient status.  Patient was then observed to have hives around her neck, upper chest and arms.  RN then called again at 1924.  Was advised to send patient to the ED. RN called ambulance and was advised to administer epinephrine.  Pharmacist pulled up 0.3mL of epinephrine.  Administered injection in right thigh at 1934.  Ambulance called and arrived on site at 1936.   Patient was assessed, IV access secured and transferred to ED for further observation. Observed for 4 hours with improvement in symptoms. sent home with prednisone. Patient contacted the next day and reported hives on arms, face, back, hands as well as swollen lips and fever to 101.6. Contacted again the following day and symptoms were resolving. Patient is tracking symptoms in VSAFE
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Oxygen saturation
Clinical narrative: Considering patient's history and physical examination, suspect allergic reaction and possible angioedema to the Covid vaccine.  Patient has been advised to continue taking Benadryl 50 mg every 6 hours for 24 hours and slowly taper the medication to take as needed.  Patient has been advised to continue prednisone 60 mg daily for an additional 3 days.  She will also be given a prescription for Pepcid 20 mg twice a day for 4 days.   Patient will be given a prescription for EpiPen as needed for potential angioedema. At this time, there is no significant findings warranting admission or emergent interventions.  Patient will be discharged home with a prescription for Benadryl 50 mg, Pepcid 20 mg and EpiPen. Patient has been advised to follow-up with healthcare facility for recheck on Monday, 12/21/2020. Strict return precautions were discussed.  Advised by PCP not to have second dose
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Nervousness, Palpitations, Throat irritation
Clinical narrative: Got COVID vaccine dose #1 around 0740-0745, waited the 15 minutes then was driving home from hospital, throat felt a radiating warmth from the inside, hard to swallow, heart was racing, felt light headed and shakey. Pulled over and called EMS at exactly 0816. Symptoms subsided after 20 minutes. EMS took vitals but did not get transported to hospital.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure increased, Dyspnoea, Impaired driving ability
Clinical narrative: Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days.  Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Urticaria, Visual impairment
Clinical narrative: Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days.  Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: About 6 hrs after vaccine, I started itching down around my ankles and it kept getting worse and it spread and into the next day. I tried to deal with it with Benadryl for 5 days  Urgent Care  and was given:  4 - Zyrtec and -2-  Xantac : took that once a day for two days. Symptoms started resolving after that. Still had itching for 3-4 days after that but it was mild and then it went away. Went to my Rheumatogist and he said to take Prednisone but I didn't.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Discomfort, Dizziness, Gait inability, Palpitations
Clinical narrative: at minute 3 after receiving vaccine, a weird sensation started at the top of my head and went to my feet, 5 minutes later happened again. then felt like I was going pass out.  BP was elevated, heart racing slightly. after about 15 minutes face around eyes started tingling off and on, throat was tingling 2 separate times but didn't last long. body started feeling very heavy and lost all movement from my waist down in both legs. tingling eventually went away. was able to finally start walking about 3 and 1/2 hours after was given the vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal paraesthesia, Sensory disturbance
Clinical narrative: at minute 3 after receiving vaccine, a weird sensation started at the top of my head and went to my feet, 5 minutes later happened again. then felt like I was going pass out.  BP was elevated, heart racing slightly. after about 15 minutes face around eyes started tingling off and on, throat was tingling 2 separate times but didn't last long. body started feeling very heavy and lost all movement from my waist down in both legs. tingling eventually went away. was able to finally start walking about 3 and 1/2 hours after was given the vaccine
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Dizziness
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Nausea, SARS-CoV-2 test, Urine analysis
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Chills, Diarrhoea
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache, Impaired work ability, Loss of personal independence in daily activities, Nausea
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Tryptase
Clinical narrative: Metallic taste (cold house key) 30-45 sec. middle of tongue, width 1-2 mm; Left lips went numb (upper and lower)/left tip of tongue numb; lower lip felt swollen again; left tip of tongue tingling; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received second dose (pending clarification) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included known allergies. The patient is not pregnant. Concomitant medication included unspecified medications (the patient received medications within 2 weeks of vaccination). It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and the patient had not been tested for COVID-19 since the vaccination. On 02Jan2021 10:30, the patient received first dose of COVID Pfizer vaccine. On 02Jan2021 11:00, the patient experienced "1st" tip of tongue numb, metallic taste, and lower left lip felt swollen. On an unspecified date, the patient experienced "2nd" (pending clarification) metallic taste (cold house key) 30-45 sec. middle of tongue, width 1-2 mm; left lips went numb (upper and lower); lower lip felt swollen again; and left tip of tongue numb and tingling, these tongue problems lasted for few days. The events resulted physician's clinic visit. The events were reported non-serious. Therapeutic measures were taken as a result of these events with injection 50 mg Benadryl left (L) thigh. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Tryptase
Clinical narrative: Metallic taste (cold house key) 30-45 sec. middle of tongue, width 1-2 mm; Left lips went numb (upper and lower)/left tip of tongue numb; lower lip felt swollen again; left tip of tongue tingling; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received second dose (pending clarification) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included known allergies. The patient is not pregnant. Concomitant medication included unspecified medications (the patient received medications within 2 weeks of vaccination). It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and the patient had not been tested for COVID-19 since the vaccination. On 02Jan2021 10:30, the patient received first dose of COVID Pfizer vaccine. On 02Jan2021 11:00, the patient experienced "1st" tip of tongue numb, metallic taste, and lower left lip felt swollen. On an unspecified date, the patient experienced "2nd" (pending clarification) metallic taste (cold house key) 30-45 sec. middle of tongue, width 1-2 mm; left lips went numb (upper and lower); lower lip felt swollen again; and left tip of tongue numb and tingling, these tongue problems lasted for few days. The events resulted physician's clinic visit. The events were reported non-serious. Therapeutic measures were taken as a result of these events with injection 50 mg Benadryl left (L) thigh. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Lip swelling, Paraesthesia oral
Clinical narrative: Metallic taste (cold house key) 30-45 sec. middle of tongue, width 1-2 mm; Left lips went numb (upper and lower)/left tip of tongue numb; lower lip felt swollen again; left tip of tongue tingling; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received second dose (pending clarification) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included known allergies. The patient is not pregnant. Concomitant medication included unspecified medications (the patient received medications within 2 weeks of vaccination). It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and the patient had not been tested for COVID-19 since the vaccination. On 02Jan2021 10:30, the patient received first dose of COVID Pfizer vaccine. On 02Jan2021 11:00, the patient experienced "1st" tip of tongue numb, metallic taste, and lower left lip felt swollen. On an unspecified date, the patient experienced "2nd" (pending clarification) metallic taste (cold house key) 30-45 sec. middle of tongue, width 1-2 mm; left lips went numb (upper and lower); lower lip felt swollen again; and left tip of tongue numb and tingling, these tongue problems lasted for few days. The events resulted physician's clinic visit. The events were reported non-serious. Therapeutic measures were taken as a result of these events with injection 50 mg Benadryl left (L) thigh. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Dysphagia, Feeling of body temperature change, Headache
Clinical narrative: Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing .  Treated at WS GSH ED   Was given Benadryl, Prednisone and Pepcid orally   Was discharged after 4 hours
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Nausea, Pharyngeal swelling, Tremor
Clinical narrative: Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing .  Treated at WS GSH ED   Was given Benadryl, Prednisone and Pepcid orally   Was discharged after 4 hours
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Dysphagia, Heart rate increased, Nausea
Clinical narrative: Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing .  Treated at WS GSH ED   Was given Benadryl, Prednisone and Pepcid orally   Was discharged after 4 hours
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: Dizziness, Nausea, clammy, shaky, trouble swallowing, throat closing, pulse racing .  Treated at WS GSH ED   Was given Benadryl, Prednisone and Pepcid orally   Was discharged after 4 hours
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: Diagnosed with Cellulitis, following up with PCP
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inflammation
Clinical narrative: Diagnosed with Cellulitis, following up with PCP
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis
Clinical narrative: Diagnosed with Cellulitis, following up with PCP
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: "Pfizer-Bio-Tech COVID-19 Vaccine EUA" Physician contacted staff in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at County Health Department. The event was reported to Epidemiologist.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Back pain, Chills, Headache, Myalgia
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness, Hypoacusis
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Back pain, Chills, Deafness unilateral
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Exposure to SARS-CoV-2, Middle ear effusion, Myalgia, Pain in extremity
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Back pain, Chills, Deafness
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: Tinnitus started in right ear within hour after receiving first vaccination but resolved within a couple of day. Within 24 hours of receiving second vaccination had muffled hearing, Jan 3, 2021. Symptoms were ignored thinking they would resolve. When symptoms persisted and evaluated patient was noted to have a severe right sided low frequency hearing loss with poor word recognition score.  Patient was started on high dose steroids with partial recovery of symptoms.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dysuria, Micturition urgency, Nausea
Clinical narrative: On 1/3/2021, patient began to experience rigors, malaise, and minimally productive cough. Patient received Moderna COVID-19 vaccination on 12/31/2020. Patient was admitted to the hospital and treated for community acquired pneumonia. Patient was treated with ceftriaxone and azithromycin followed by levofloxacin. Patient was COVID-19 negative.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Pollakiuria, Vomiting
Clinical narrative: On 1/3/2021, patient began to experience rigors, malaise, and minimally productive cough. Patient received Moderna COVID-19 vaccination on 12/31/2020. Patient was admitted to the hospital and treated for community acquired pneumonia. Patient was treated with ceftriaxone and azithromycin followed by levofloxacin. Patient was COVID-19 negative.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture negative, Chills, Malaise, Pneumonia, Productive cough
Clinical narrative: On 1/3/2021, patient began to experience rigors, malaise, and minimally productive cough. Patient received Moderna COVID-19 vaccination on 12/31/2020. Patient was admitted to the hospital and treated for community acquired pneumonia. Patient was treated with ceftriaxone and azithromycin followed by levofloxacin. Patient was COVID-19 negative.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: On 1/3/2021, patient began to experience rigors, malaise, and minimally productive cough. Patient received Moderna COVID-19 vaccination on 12/31/2020. Patient was admitted to the hospital and treated for community acquired pneumonia. Patient was treated with ceftriaxone and azithromycin followed by levofloxacin. Patient was COVID-19 negative.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Pyrexia, Tachycardia
Clinical narrative: My eyes still very heavy and warm; My eyes still very heavy and warm; Dizzy; Started getting super super cold; Fever/101 fever; Heart was extremely fast; Blood pressure also went up; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient got the vaccine yesterday and as soon as like not even about 12 minutes after patient had received the vaccine patient heart was extremely fast and blood pressure also went up. Patient stabilized like after 10 minutes 'signs were fine'. But then patient started getting super cold. Patient was extremely cold. The doctors monitored the patient at the hospital for a little bit but then they told the patient the best thing to do just go home rest and lay down which patient did .But the symptoms yesterday patient got a fever, it was 101 fever and then patient was fine so patient slept okay but this morning (09Jan2021) patient was not feeling better. Patient felt very dizzy. Patient did know the symptoms. But patient did not know if it is an allergic reaction to the vaccine. Patient eyes were still very heavy and warm and patient was again dizzy. Outcome of heart was extremely fast and blood pressure also went up was recovered on 08Jan2021, outcome of other events was unknown.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Abnormal sensation in eye, Asthenopia, Blood pressure increased, Blood pressure measurement, Body temperature
Clinical narrative: My eyes still very heavy and warm; My eyes still very heavy and warm; Dizzy; Started getting super super cold; Fever/101 fever; Heart was extremely fast; Blood pressure also went up; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient got the vaccine yesterday and as soon as like not even about 12 minutes after patient had received the vaccine patient heart was extremely fast and blood pressure also went up. Patient stabilized like after 10 minutes 'signs were fine'. But then patient started getting super cold. Patient was extremely cold. The doctors monitored the patient at the hospital for a little bit but then they told the patient the best thing to do just go home rest and lay down which patient did .But the symptoms yesterday patient got a fever, it was 101 fever and then patient was fine so patient slept okay but this morning (09Jan2021) patient was not feeling better. Patient felt very dizzy. Patient did know the symptoms. But patient did not know if it is an allergic reaction to the vaccine. Patient eyes were still very heavy and warm and patient was again dizzy. Outcome of heart was extremely fast and blood pressure also went up was recovered on 08Jan2021, outcome of other events was unknown.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling cold, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: My eyes still very heavy and warm; My eyes still very heavy and warm; Dizzy; Started getting super super cold; Fever/101 fever; Heart was extremely fast; Blood pressure also went up; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient got the vaccine yesterday and as soon as like not even about 12 minutes after patient had received the vaccine patient heart was extremely fast and blood pressure also went up. Patient stabilized like after 10 minutes 'signs were fine'. But then patient started getting super cold. Patient was extremely cold. The doctors monitored the patient at the hospital for a little bit but then they told the patient the best thing to do just go home rest and lay down which patient did .But the symptoms yesterday patient got a fever, it was 101 fever and then patient was fine so patient slept okay but this morning (09Jan2021) patient was not feeling better. Patient felt very dizzy. Patient did know the symptoms. But patient did not know if it is an allergic reaction to the vaccine. Patient eyes were still very heavy and warm and patient was again dizzy. Outcome of heart was extremely fast and blood pressure also went up was recovered on 08Jan2021, outcome of other events was unknown.  Information on the lot/ batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Muscle spasms
Clinical narrative: Pregnant at the time of vaccination; Pregnant at the time of vaccination; Miscarriage (symptoms started 08Jan2021, confirmed 10Jan2021); This is a spontaneous report from a contactable physician (patient herself). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration on the right arm on 06Jan2021 12:30 at a single dose for COVID-19 immunization at the hospital facility. The patient had no relevant medical history and no known allergies. Concomitant medication included azelastine;fluticasone nasal sprays, prenatal. The patient did not have any other vaccine in four weeks. She did not have COVID prior to vaccination. The patient was 6 weeks pregnant at the onset of the event. Last menstrual date was on 11Nov2020 and Gestational period was 7. The patient was due to deliver on 26Aug2021. The patient reported miscarriage (symptoms started 08Jan2021 06:00 PM, confirmed 10Jan2021). The event resulted in doctor or other healthcare professional office/clinic visit, Congenital anomaly or birth defect. Treatment and event outcome were unknown. The patient had not been COVID tested post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: Based on a close compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to patient's miscarriage cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.