chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Throat irritation
Clinical narrative: Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed to SOB, pruritis throat tickle TxT-ed self with Benadrl but symptoms persisted Went to ED txt with Bendryl, prednisone, zyrtec.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash 50% body develops 12 days after 2nd. Had no rxn at time of injection Txt: Antihistamines steroids
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Motor dysfunction, Paraesthesia
Clinical narrative: - My fingers are tingling - I can't grab anything or type very well
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Nodule
Clinical narrative: Left arm started to swell 8 days after vaccine - pruritis hot, & some axillary swelling & small nodules - increased swelling dramatically in 24hrs; spread to under the arm. 8 inches L x 8" width
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: This patient was administered 1.0ml of the COVID19 Moderna Vaccine instead of the recommended dosage of .5ml. All other procedures were followed correctly. After this event occurred, the patient was monitored and no adverse reactions were observed.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This patient was administered 1.0ml of the COVID19 Moderna Vaccine instead of the recommended dosage of .5ml. All other procedures were followed correctly. After this event occurred, the patient was monitored and no adverse reactions were observed.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: This patient was administered 1.0ml of the COVID19 Moderna Vaccine instead of the recommended dosage of .5ml. All other procedures were followed correctly. After this event occurred, the patient was monitored and no adverse reactions were observed.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness & swelling
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Fatigue Headache Pain at injection site fatigue Muscle pain
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Chills Fever Headache Injection site redness & pain
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills Fever Headache Injection site redness & pain
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This patient was administered 1.0ml of the COVID19 Moderna Vaccine instead of the recommended dosage of .5ml. All other procedures were followed correctly. After this event occurred, the patient was monitored and no adverse reactions were observed.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain & swelling & redness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Injection site redness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry throat, Fatigue, Headache, Injection site pain
Clinical narrative: Fatigue Pain at injection site Fever Headache Joint pain Malaise Musclepain Dry Throat
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Fatigue Pain at injection site Fever Headache Joint pain Malaise Musclepain Dry Throat
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at injection site
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash at injection site
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: chills fatigue Fever Headach Nausea Pain at injection site
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: chills fatigue Fever Headach Nausea Pain at injection site
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat
Clinical narrative: chills fatigue Fever Headach Nausea Pain at injection site
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site redness and swelling
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: joint pain Muscle pain pain at injection site
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: Pain at injection site  nausea
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: Nausea Pain at injection sit.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache Injection site redness Injection site swelling Pain at injection site
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site pain
Clinical narrative: Headache, Pain at injection site Diarrhea
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling, redness, hardness, itching
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: Muscle pain Pain at injection site
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Chills Fatigue Fever Headache injection site redness swelling Pain Joint pain Muscle pain Nausea
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills Fatigue Fever Headache injection site redness swelling Pain Joint pain Muscle pain Nausea
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Chills Fatigue Pain & swelling at injection site
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Nausea
Clinical narrative: Headache Nausea Injection site redness
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever 102 last 24 grs -  seizure
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site bruising, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Had bruised from injection. Arm was sore a couple of days. itching started yesterday 1/15/21. Today 1/16/21 arm is very swollen ( welted) hot to touch and itching.  10 days after injection. By morning large raised welt, hot to the touch and itching. Headache
Sex: U
Vaccine: COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: Had bruised from injection. Arm was sore a couple of days. itching started yesterday 1/15/21. Today 1/16/21 arm is very swollen ( welted) hot to touch and itching.  10 days after injection. By morning large raised welt, hot to the touch and itching. Headache
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stiffness in the arm that radiated to her neck as well; Redness; Slight fever; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890387-1), reported by other health professional and concerned a 70-year-old, female patient.  The patient's relevant medical history was not reported. The patient had no known allergies. The patient's concomitant medications included Wellbutrin (bupropion hydrochloride), glatiramer, venlafaxine, Avalide (hydrochlorothiazide, irbesartan), all used for unreported indications. The patient had flu shots before without adverse events.    On 16-Sep-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 279799.  On the same day, after receiving Fluad Quadrivalent, the patient had redness, slight fever and stiffness in the arm that radiated to her neck as well. The patient stated that she never experienced this before.  On 19-Sep-2020, three days after the onset, the patient recovered from events.   The reporter did not provide causality assessment.    The case was assessed as non-serious.  Company comment: A 70-year-old patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient had erythema, pyrexia and musculoskeletal stiffness in the arm that radiated to her neck. Causality is assessed as possibly related for all events.; Sender's Comments: A 70-year-old patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient had erythema, pyrexia and musculoskeletal stiffness in the arm that radiated to her neck. Causality is assessed as possibly related for all events.
Age: 65.0
Sex: F
Vaccine: FLUA4, PNC13
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Pain from top of shoulder down to elbow on left arm/moderate pain from top of shoulder down and sharp pain on right arm; Pain from top of shoulder down to elbow on left arm/moderate pain from top of shoulder down and sharp pain on right arm; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890393-1), reported by other health professional and concerned a 65-year-old, female patient.  The patient's concurrent condition included allergy to sulpha drugs. The patient's concomitant medications included fluorouracil, famotidine and melatonin, all used for unreported indications.  On 15-Oct-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: one as reported and indication: not reported). The batch number reported was 279816.   On the same day, the patient was vaccinated with non-company co-suspect vaccine Prevnar 13 (pneumococcal vaccine conj 13v (crm197), dose: one as reported, route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was CY4766.  On the same day, after receiving Fluad Quadrivalent and non-company co-suspect vaccine Prevnar 13, the patient experienced pain from top of shoulder down to elbow on left arm and moderate pain from top of shoulder down and sharp pain on right arm.  At the time of initial reporting on 23-Dec-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company comment: A 65-year-old patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent and non-company co-suspect vaccine Prevnar 13 in different arms, the patient experienced pain from top of shoulder down to elbow on left arm and moderate pain from top of shoulder down and sharp pain on right arm. Causality is assessed as possibly related for pain in extremity and arthralgia, since both arms were affected.; Sender's Comments: A 65-year-old patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent and non-company co-suspect vaccine Prevnar 13 in different arms, the patient experienced pain from top of shoulder down to elbow on left arm and moderate pain from top of shoulder down and sharp pain on right arm. Causality is assessed as possibly related for pain in extremity and arthralgia, since both arms were affected.
Age: 67.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm turned red & became hot - with some swelling; Arm turned red & became hot - with some swelling; Arm turned red & became hot - with some swelling; Fluad Quadrivalent and Pneumovax both administered in left arm; This spontaneous case from the was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890500-1), reported by other health professional and concerned a 67-year-old, female patient.  The patient's concurrent conditions included gastroesophageal reflux disease (GERD) and hypercholesterolemia. The patient's concomitant medications were not reported. The patient had no known allergies.  On 14-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported) ( Explicitly coded as 'Product administration error'). The batch number reported was 279805.  On the same day, the patient was vaccinated with non-company, co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was T027110.  On 15-Oct-2020, one day after receiving Fluad Quadrivalent and co-suspect Pneumovax, the patient's arm turned red and became hot with some swelling.  On 17-Oct-2020, the patient visited emergency department and was prescribed with a topical steroid cream triamcinolone.  The outcome of the events was unknown.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 67-year-old female patient experienced skin warm, erythema and peripheral swelling one day after administration of Fluad Quadrivalent and a non-company, co-suspect Pneumovax, both given in the same arm. Causality is assessed as possibly related for all events, however cofounded with reported medication error. Product administration error is assessed as unrelated per company conventions.; Sender's Comments: A 67-year-old female patient experienced skin warm, erythema and peripheral swelling one day after administration of Fluad Quadrivalent and a non-company, co-suspect Pneumovax, both given in the same arm. Causality is assessed as possibly related for all events, however cofounded with reported medication error. Product administration error is assessed as unrelated per company conventions.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Muscle spasms, Pain
Clinical narrative: Pain; Muscle spasm; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 891205-1), reported by other health professional and concerned a 65-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration, anatomical location and indication: not reported). The batch number reported was 279791.  On 06-Oct-2020, unknown amount of time after receiving Fluad Quadrivalent, the patient developed pain and muscle spasm which started on left side where vaccine was administrated, then spread to top of hip.  On 19-Oct-2020, the patient still felt almost the same and she had appointment with doctor.   At the time of initial reporting on 23-Dec-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A 65-year-old female patient experienced pain and muscle spasms unknown amount of time after administration of Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. Causality is unassessable due to lack of provided information.; Sender's Comments: A 65-year-old female patient experienced pain and muscle spasms unknown amount of time after administration of Fluad Quadrivalent. The patient's medical history and concomitant medications were not reported. Causality is unassessable due to lack of provided information.
Age: 80.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Periorbital swelling, Rash
Clinical narrative: Swelling around the eyes; Rash in groin area, trunk, and arms; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 891255-1) reported by other health professional and concerned an 80-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 07-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one; route of administration: intramuscular; anatomical location and indication not reported). The batch number reported was 279784.  On the same day, the patient was vaccinated with non-company, co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; dose reported as one; route of administration: intramuscular; anatomical location and indication: not reported). The batch number reported was S034299.   On 09-Oct-2020, two days after receiving Fluad Quadrivalent and Pneumovax, the patient experienced rash in groin area, trunk and arms. She also experienced swelling around the eyes and recognized symptoms and began treatment with diphenhydramine, at dose of 25 mg for four consecutive doses.   Through Saturday, 10-Oct-2020, the patient took diphenhydramine, and on that day stopped treatment.   On an unspecified date in Oct-2020, the patient recovered from events as it was reported that symptoms resolved over the next 48 hours.   On 20-Oct-2020, the patient came to pharmacy to report adverse event.   The reporter assessed the events to be related to Fluad Quadrivalent.   The case was assessed as non-serious.  Company comment: A 80-year-old female patient experienced periorbital swelling and rash 2 days after administration of Fluad Quadrivalent and a non-company, co-suspect Pneumovax. Causality is assessed as possibly related for both events due to temporal plausibility, however confounded with reported co-suspect vaccine.; Reporter's Comments: The patient came to pharmacy to report adverse event.; Sender's Comments: A 80-year-old female patient experienced periorbital swelling and rash 2 days after administration of Fluad Quadrivalent and a non-company, co-suspect Pneumovax. Causality is assessed as possibly related for both events due to temporal plausibility, however confounded with reported co-suspect vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Itchy Palm Rash broke out and spread to wrist and arm; This is a spontaneous report from a contactable physician (patient). This report was received via a sales representative. A male patient of an unspecified age received bnt162b2 (COVID 19 vaccine) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced itchy palm rash broke out and spread to wrist and arm on an unspecified date. The adverse event took place after Pfizer product use. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chest X-ray, Chest wall mass, Costochondritis, Electrocardiogram
Clinical narrative: Chest swelling on my right side started 12/27/2020 and I ended up having to go to the ER. Chest swelling, redness, and sensitive to touch on the right side of my chest. Met with a cardiologist on 1/6/2021 due to severe side effects of the vaccine and Dr. said I know have Costochondritis
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Sensitive skin
Clinical narrative: Chest swelling on my right side started 12/27/2020 and I ended up having to go to the ER. Chest swelling, redness, and sensitive to touch on the right side of my chest. Met with a cardiologist on 1/6/2021 due to severe side effects of the vaccine and Dr. said I know have Costochondritis
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Haemophilia, Panic attack, Tremor
Clinical narrative: Immediately following vaccine my entire chest began very hot.  I was having hard time breathing.  I started trembling a little and my vision became blurry. Doctors told me I had bad panic attack.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Immediately following vaccine my entire chest began very hot.  I was having hard time breathing.  I started trembling a little and my vision became blurry. Doctors told me I had bad panic attack.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lymphadenopathy, Neck pain, Pain
Clinical narrative: "12/27/2020 low grade fever, aches and pain . 5:15 next morning  vomiting ,bad headaches for few days, neck pain with swollen glands, dizziness, sore arm to left underarm to  sore ribs"
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: "12/27/2020 low grade fever, aches and pain . 5:15 next morning  vomiting ,bad headaches for few days, neck pain with swollen glands, dizziness, sore arm to left underarm to  sore ribs"
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Pruritus, Rash
Clinical narrative: Hives, rash, itching, nausea, vomiting,  headache, swollen lymph nodes
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives, rash, itching, nausea, vomiting,  headache, swollen lymph nodes
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Exposure to SARS-CoV-2, Pruritus, Rash, Swollen tongue
Clinical narrative: Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Swollen tongue, hives, red rash all over chest/neck/arms, burning and itching. IV of benedryl and Pepcid and observation in ER for 3 hours. Rash, hives, burning and itching continue which worsen when exposed to someone with Covid.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Erythema, Feeling hot, Palpitations
Clinical narrative: On 12/29/2020 I took the 1st Moderna Covid-19 vaccine dose through my employer. Immediately afterward I felt a warm sensation down my left arm and then up my torso into my face. My face and neck turned red. I felt light headed and my chest was heavy feeling. My heart began to race. I waited the 30 minutes they asked me to wait and then asked the medic if these side effects were normal. He said no and gave me a Benadryl because I might be having an allergic reaction. The medical staff performed an EKG because my blood pressure was 160/100 which is not normal for me. The EKG was normal but they called an ambulance to get a better test. My second blood pressure check went down to 140/82. They wanted me to go to the hospital but I did not go.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Dizziness
Clinical narrative: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
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: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Nausea, SARS-CoV-2 test, Urine analysis
Clinical narrative: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Chills, Diarrhoea
Clinical narrative: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
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: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: slight nausea; dizziness; body weakness; 3 types of diarrhea; I have been sick ever since; I am not able to work; chills; 102.9 F/low-grade temperature (99.2-99.8 F); This is a spontaneous report from a contactable nurse. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had side effects that are "fluctuated but up until now". She had 1 episode of chills (102.9 F), slight nausea, low-grade temperature (99.2-99.8 F) almost everyday, dizziness, body weakness, 3 types of diarrhea, starting to resolve, most concerned (lasting almost 11 days now). The patient received the first COVID vaccine on 29Dec2020 and she has been sick ever since. Patient was negative for COVID. She already sought help from doctor and went to the ER last night. She had slight to moderate symptoms and not fully recovered. She was not able to work. She was relating this to the vaccine as she was fine before. She went travelling back in March and became ill. They were not testing for COVID back then and she recovered. I wonder if I had COVID back then. She was glad it is her turn. She has been waiting a long time. It has been a concern. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses are expected for most people. On 30Dec2020 she had chills and temperature of 102.9. That subsided by taking Tylenol and rest. After that she felt sick like headache, dizziness, and low-grade temp until now. She hasn't been back to work. She has already sought advice from her doctor. She went to the ER last night to make sure she is ok because it was not resolving. Her COVID test was negative two days ago. Before the COVID shot she was healthy, working, and no symptoms of anything. After the shot, all this. Patient then asked if anyone else experienced these and if these were vaccine related. She would like to know what to do to confirm it was vaccine, how long will she be off work. The ER doctor said that she could have had the virus before she had the shot or after, but it is a slim chance now that she is COVID negative. Before she knew if she was COVID negative or positive, she went on the website and filled it out. Now that she has confirmed that she is negative what could cause this illness after the shot. She did that before she knew she was COVID negative. When she had her first shot of COVID vaccine on 29Dec2020, she started having side effects, which she guesses is expected for most people. Outcome of the event "102.9 F/low-grade temperature (99.2-99.8 F)" and chills was recovered, while outcome of the other events was unknown.  Information on batch/lot number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: Patient felt hot tingling sensation traveling up her right arm. BP 120/70; HR 80; Lungs clear bilaterally, PERL.  1359 gave benadyl 5 mL Patient declined EMS transport. BP 120/90; HR 84; BBS, PERL per EMT assessment Patient discharged per EMT. Patient left ambulatory to personal vehicle.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry throat, Periorbital swelling, Throat irritation
Clinical narrative: Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Eye swelling, Tachycardia, Throat tightness
Clinical narrative: Dizziness, eye swelling, throat tightness, sense of impending doom, mild tachycardia
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Headache, Impaired work ability
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (HCP) (parent). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The other HCP called on behalf of her 27-year-old daughter requesting an urgent callback. On an unspecified date, the daughter had an anaphylactic reaction, continuing on medications that cannot be tapered and was hospitalized. She has an appointment on 11Jan2021 with a general practitioner. It was asked what happens when you become allergic to the spike protein? How long does it continue to make the spike protein? Do "we" have any ideas if she is exposed to the virus/spike protein would she experience another adverse reaction as she works in healthcare? Is there a way to break the cycle? The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on an implied chronological association and known BNT162B2 vaccine safety profile, a causal relationship between event Anaphylactic reaction and BNT162B2 (PFIZER-BIONTECH COVID-19 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.