chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Sensory disturbance, Skin discolouration, Skin swelling
Clinical narrative: 12/27/2021- at 4:00pm I noticed raised skin on the back of my neck and behind my ears.  12/28/2021- at 3:00am I awoke and soon after began experiencing a constant severe shooting sensation going from the bottom of my rib cage to the top of my throat. When I awoke again that morning at 7:00am that sensation was still there & continued on until approximately 7:00pm that night. I also began feeling my skin itching and noticed the bumps and welts were now going throughout my body and felt warm. I almost through up twice and my body was going in and out extreme heat and chills at 9:30am. After driving around to different urgent cares, I was finally seen around 2:00pm that day where the doctor witnessed my skin reaction worsening by the minutes. I was prescribed steroids and didn?t mention the vaccine as it didn?t cross my mind. That evening, my feet began to really hurt to walk on and my right foot swelled up.  12/29/2021- my feet began looking purple by the toes and the pain worsened. My skin continued breaking out everywhere but my throat wasn?t constantly having the shooting pain. 12/30/2021- I had a teladoc apt at which point the doctor pointed out this was an internal foreign body that entered my body approximately ten days before symptoms began presenting themselves. The Covid vaccine booster was exactly 10 days and 23 hours before my symptoms began and she said it is definitely a possibility for my reactions.  TODAY- my skin is still reacting but it?s mostly red rashes with raises skin and some tiny bumps.  It?s still happening across my body. My throat still isn?t healed yet and is uncomfortable and has a very faded version of the shooting sensation going up it during the day. I was also wheezing early on from this.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: 12/27/2021- at 4:00pm I noticed raised skin on the back of my neck and behind my ears.  12/28/2021- at 3:00am I awoke and soon after began experiencing a constant severe shooting sensation going from the bottom of my rib cage to the top of my throat. When I awoke again that morning at 7:00am that sensation was still there & continued on until approximately 7:00pm that night. I also began feeling my skin itching and noticed the bumps and welts were now going throughout my body and felt warm. I almost through up twice and my body was going in and out extreme heat and chills at 9:30am. After driving around to different urgent cares, I was finally seen around 2:00pm that day where the doctor witnessed my skin reaction worsening by the minutes. I was prescribed steroids and didn?t mention the vaccine as it didn?t cross my mind. That evening, my feet began to really hurt to walk on and my right foot swelled up.  12/29/2021- my feet began looking purple by the toes and the pain worsened. My skin continued breaking out everywhere but my throat wasn?t constantly having the shooting pain. 12/30/2021- I had a teladoc apt at which point the doctor pointed out this was an internal foreign body that entered my body approximately ten days before symptoms began presenting themselves. The Covid vaccine booster was exactly 10 days and 23 hours before my symptoms began and she said it is definitely a possibility for my reactions.  TODAY- my skin is still reacting but it?s mostly red rashes with raises skin and some tiny bumps.  It?s still happening across my body. My throat still isn?t healed yet and is uncomfortable and has a very faded version of the shooting sensation going up it during the day. I was also wheezing early on from this.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Paraesthesia, Peripheral swelling, Swelling
Clinical narrative: swelling in hands and ankles.  tingling in hands arms feet. swelling on and off
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant, Thrombosis
Clinical narrative: blood clotting cancer; blood clotting cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), THROMBOSIS (medically significant), outcome "unknown" and all described as "blood clotting cancer". The reporter stated that one of her relatives, who received the vaccine developed blood clotting cancer but still took the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sick with covid; sick with covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome unknown. The patient was in clinical trial for the covid vaccine and was not yet eligible for the booster within the trial. It prevented patient from getting a booster and patient was now sick with covid. Reporter questioned will patient be helped for treatment.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Immunisation, Off label use, Weight
Clinical narrative: HBP controlled with medication and on a statin; I received my 3rd Pfizer booster dose 4 months ago; I received my 3rd Pfizer booster dose 4 months ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "kidney cancer" (unspecified if ongoing), notes: 2 time cancer survivor, 1 kidney due to removal of kidney due to kidney cancer; "removal of kidney" (unspecified if ongoing), notes: 2 time cancer survivor, 1 kidney due to removal of kidney due to kidney cancer. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Aug2021, outcome "unknown" and all described as "I received my 3rd Pfizer booster dose 4 months ago"; HYPERTENSION (non-serious), outcome "recovering", described as "HBP controlled with medication and on a statin". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid infection; Breakthrough Covid infection; Sore throat; slight cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jun2021 (Lot number: EW0181) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose: 01, Lot No EN0217), administration date: 08Jun2021, when the patient was 18 years old, for Covid-19 immunization. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome recovering; OROPHARYNGEAL PAIN (non-serious) with onset 26Dec2021, outcome recovering; COUGH (non-serious) with onset 26Dec2021, outcome recovering. The patient underwent the following laboratory tests and procedures sars-cov-2 test (27Dec2021) positive, Nasal Swab. Advil was taken as the Therapeutic measures as a result of vaccination failure, covid-19, oropharyngeal pain, cough.  Patient was detected Covid positive on 28Dec2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Immunisation, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: enlarged heart; booster; his oxygen level this morning was in the 80's and is on oxygen now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1,Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for covid-19 immunization. The following information was reported: CARDIOMEGALY (hospitalization), outcome "unknown", described as "enlarged heart"; IMMUNISATION (hospitalization) with onset 27Sep2021, outcome "unknown", described as "booster"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "his oxygen level this morning was in the 80's and is on oxygen now". The event "enlarged heart" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: 80. Therapeutic measures were taken as a result of oxygen saturation decreased.  Additional Information: Caller reported her husband started to have issues at 12:01 AM this morning. Caller reported she took her husband to the clinic and he was taken to the hospital from the clinic by ambulance. Caller reported her husband is in the hospital now. Caller reported he was tested and found he has an enlarged heart. Caller reported his oxygen level this morning was in the 80's and is on oxygen now. Caller stated she first did not think it was related to the vaccine but found out her sister that got her booster around the same time had  similar issues and also had an enlarged heart after the vaccine so she thought it might be related to the vaccine. Caller asked are there reports of occurrences 3 months after the booster. Caller asked is this a common occurrence for anyone else.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Idiopathic pulmonary fibrosis, Immunisation, Rheumatoid arthritis
Clinical narrative: I have idiopathic pulmonary fibrosis; rheumatoid arthritis; heart problems; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation.  The following information was reported: IDIOPATHIC PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "I have idiopathic pulmonary fibrosis"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "rheumatoid arthritis"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster". It was reported the patient was waiting to have a procedure for a vein that has a little puncture. Therapeutic measures were taken as a result of idiopathic pulmonary fibrosis, rheumatoid arthritis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism
Clinical narrative: Thyroid function decreased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Celiac disease" (ongoing); "Soy allergy" (unspecified if ongoing); "Milk allergy" (unspecified if ongoing); "Thyroid function abnormal" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown", described as "Thyroid function decreased".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Rash macular, Scleroderma
Clinical narrative: lilac and bright red spots of 0.5 centimeters - 7 centimeters appeared in  the abdomen, under the arms, and between the legs; I began to feel unwell; dizziness; weakness; was diagnosed with Scleroderma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 13Sep2021, for Covid-19 immunization, reaction(s): "didn't feel any negative reactions". The following information was reported: SCLERODERMA (medically significant) with onset 2021, outcome "unknown", described as "was diagnosed with Scleroderma"; RASH MACULAR (non-serious) with onset 18Oct2021, outcome "unknown", described as "lilac and bright red spots of 0.5 centimeters - 7 centimeters appeared in the abdomen, under the arms, and between the legs"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "I began to feel unwell"; DIZZINESS (non-serious) with onset 18Oct2021, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 18Oct2021, outcome "unknown", described as "weakness". The events "was diagnosed with scleroderma", "i began to feel unwell", "dizziness" and "weakness" were evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included covid, start date: Feb2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), IMMUNISATION (medically significant) all with onset 2021, outcome unknown. Patient reported Covid went right into lungs and the shots had provided zero protection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: He had PCR +; He had PCR + with covid symptoms; dose_number=3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Nov2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single, and intramuscular, administered in arm left, administration date 01Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported IMMUNISATION (medically significant) with onset 23Nov2021, outcome unknown; VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome unknown; COVID-19 (medically significant) with onset 28Dec2021, outcome unknown. The event he had pcr + with covid symptoms was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (28Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The case was reported as serious.  No follow-up attempts are possible. No further information is expected. Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure is expected. The case will be reassessed further upon receipt of additional information.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: currently infecting Omicron variant; currently infecting Omicron variant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a program (005570), other case identifier(s) US-PFIZER INC-202101882352.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown. It was reported that, the patient currently infecting Omicron variant and wondering how long should the patient had to wait to get the booster shot once the patient get out of it. Enquired, can the patient get vaccinated right away or the patient had to wait.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 19.; Tested positive for COVID 19.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 5 years as dose 2 (tris), single and administered in arm left (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included FLU taken for immunisation. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome recovering. The patient underwent the following laboratory tests and procedures sars-cov-2 test (24Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Device Date 29Dec2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain assessment, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe pain on left arm, reaching 10/10; cannot sleep more; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jun2021 (Lot number: EW0180) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Dilated cardiomyopathy" (unspecified if ongoing); "Known allergies Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. Concomitant medication(s) included: CARVEDILOL; ENTRESTO. Vaccination history included: Bnt162b2 (Dose Number: 1, vaccine location=Left arm, prev dose lot number: EW0177), administration date: 15May2021, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 04Jun2021, outcome "not recovered", described as "Severe pain on left arm, reaching 10/10"; INSOMNIA (medically significant) with onset 04Jun2021, outcome "not recovered", described as "cannot sleep more". The events "severe pain on left arm, reaching 10/10" and "cannot sleep more" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: pain assessment: (04Jun2021) 10/10; sars-cov-2 test: (11Dec2021) negative, notes: Nasal swab. Therapeutic measures were taken as a result of pain in extremity, insomnia. Clinical course: The patient had severe pain on left arm, reaching 10/10, she cannot sleep more than 4-5 hours without being awakened by intense pain. AE resulted in Doctor or other healthcare professional office/clinic visit. AE treatment: Steroid shot into left sub acromial bursa. The patient had no covid prior vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pneumonia, SARS-CoV-2 test
Clinical narrative: pneumonia; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A-80-year-old male patient received BNT162B2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "all kinds of pulmonary problems" (unspecified if ongoing), notes: Verbatim: all kinds of pulmonary problems. The patient concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose:1), administration date: Jan2021, for COVID-19 Immunization. The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "pneumonia"; ILLNESS (hospitalization) with onset 2021, outcome "unknown", described as "sick". The patient was hospitalized for pneumonia, illness (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Covid tests and both were negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy
Clinical narrative: Recently diagnosed with cardiomyopathy a couple months after vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 47 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown", described as "Recently diagnosed with cardiomyopathy a couple months after vaccine".  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Cold; Chest Pain; Coughing; Sore Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization.  The following information was reported: NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "Cold"; CHEST PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Chest Pain"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "Coughing"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Sore Throat".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Fall, Loss of control of legs, Nervous system disorder
Clinical narrative: loss of control of lower body; neurological disorder; fell a couple of times; Potassium level very low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONTROL OF LEGS (medically significant), outcome "unknown", described as "loss of control of lower body"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological disorder"; FALL (non-serious), outcome "unknown", described as "fell a couple of times"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium level very low". The patient underwent the following laboratory tests and procedures: blood potassium: very low; scan: nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Scan
Clinical narrative: loss of control of lower body; neurological disorder; fell a couple of times; Potassium level very low; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONTROL OF LEGS (medically significant), outcome "unknown", described as "loss of control of lower body"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "neurological disorder"; FALL (non-serious), outcome "unknown", described as "fell a couple of times"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium level very low". The patient underwent the following laboratory tests and procedures: blood potassium: very low; scan: nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Headache, Suspected COVID-19
Clinical narrative: I got COVID; it was very mild case; I got COVID; it was very mild case; Headache; I was extremely fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER3732, Expiration Date: 26Mar2021) at the age of 68 years as dose 2, single and administration date 25Feb2021 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included infection (unspecified if ongoing); smoker (unspecified if ongoing), of 54 years; surgery (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Flu shot, for Immunization. The following information was reported DRUG INEFFECTIVE (medically significant) with onset 2021, outcome unknown, SUSPECTED COVID-19 (medically significant) with onset 2021, outcome recovered (2021); it was very mild case; HEADACHE (non-serious) with onset 2021, outcome unknown; FATIGUE (non-serious) with onset 2021, outcome unknown. The patient underwent the following laboratory tests and procedures covid-19 positive. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19, headache, and fatigue.  Consumer further stated, I have something to tell you too. You know I got COVID. But it was very mild case because I had both of the vaccinations and I got it from my son and he got it from my nephew who never had COVID (Further clarifications unknown), but was a carrier and I have an open wound it is been like that for rough six years because I have an infection and they have to do surgery and this was that my weird part and it was a creepy part I got leeches (Further clarifications unknown) and don't ask me how I got leeches because I have no idea. Leeches on my foot and after you know they were there for a while because I do not know they were there and my foot always wrapped. But I think that day wasn't wrapped really tightly and after this the leeches removed some blood, I got rid of my COVID, my COVID symptoms.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Back pain, Cough, Drug ineffective, Fatigue, Nasal congestion
Clinical narrative: On 30 Nov 2021, the patient had Covid-19.; On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days.; Pain in extremity; Low back pain; Sinus pressure; Cold; Fatigue; dry cough; stuffy nose; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4206386-00 (AbbVie).  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19."; SUSPECTED COVID-19 (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Pain in extremity"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Low back pain"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 2021, outcome "recovered", described as "Sinus pressure"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "Cold"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "dry cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "stuffy nose". The patient underwent the following laboratory tests and procedures: pyrexia: (unspecified date) 102.0; sars-cov-2 test: (30Nov2021) unknown. The action taken for risankizumab was unknown.The reporter's causality for the event(s) of COVID-19, pain/soreness in feet, hands and legs, pain/soreness in lower back, sinus pressure, fatigued and cold with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected covid-19, pain in extremity, back pain, paranasal sinus discomfort, nasopharyngitis, fatigue, cough and nasal congestion with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Pain in extremity, Paranasal sinus discomfort, Pyrexia, SARS-CoV-2 test
Clinical narrative: On 30 Nov 2021, the patient had Covid-19.; On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days.; Pain in extremity; Low back pain; Sinus pressure; Cold; Fatigue; dry cough; stuffy nose; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4206386-00 (AbbVie).  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19."; SUSPECTED COVID-19 (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Pain in extremity"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Low back pain"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 2021, outcome "recovered", described as "Sinus pressure"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "Cold"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "dry cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "stuffy nose". The patient underwent the following laboratory tests and procedures: pyrexia: (unspecified date) 102.0; sars-cov-2 test: (30Nov2021) unknown. The action taken for risankizumab was unknown.The reporter's causality for the event(s) of COVID-19, pain/soreness in feet, hands and legs, pain/soreness in lower back, sinus pressure, fatigued and cold with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected covid-19, pain in extremity, back pain, paranasal sinus discomfort, nasopharyngitis, fatigue, cough and nasal congestion with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19
Clinical narrative: On 30 Nov 2021, the patient had Covid-19.; On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days.; Pain in extremity; Low back pain; Sinus pressure; Cold; Fatigue; dry cough; stuffy nose; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4206386-00 (AbbVie).  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19."; SUSPECTED COVID-19 (medically significant) with onset 30Nov2021, outcome "unknown", described as "On 30 Nov 2021, the patient had Covid-19.Symptoms of fever 102.0 for three or four days."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Pain in extremity"; BACK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Low back pain"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 2021, outcome "recovered", described as "Sinus pressure"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "not recovered", described as "Cold"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "dry cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "stuffy nose". The patient underwent the following laboratory tests and procedures: pyrexia: (unspecified date) 102.0; sars-cov-2 test: (30Nov2021) unknown. The action taken for risankizumab was unknown.The reporter's causality for the event(s) of COVID-19, pain/soreness in feet, hands and legs, pain/soreness in lower back, sinus pressure, fatigued and cold with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected covid-19, pain in extremity, back pain, paranasal sinus discomfort, nasopharyngitis, fatigue, cough and nasal congestion with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: COVID arm - large red rash at injection site; COVID arm - large red rash at injection site; Warm to the touch and sore; Warm to the touch and sore; Mild nausea; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 27Dec2021 (Lot number: FJ1611) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), all with onset 29Dec2021 at 10:00, outcome "recovering", and all described as "COVID arm - large red rash at injection site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), all with onset 29Dec2021 at 10:00, outcome "recovering", and all described as "Warm to the touch and sore"; NAUSEA (non-serious) with onset 29Dec2021 at 10:00, outcome "recovering", described as "Mild nausea". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site warmth, vaccination site pain and nausea.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included over the counter (OTC) pain relief and antihistamines for vaccination site rash, vaccination site erythema, vaccination site warmth, vaccination site pain and nausea.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: For 4 days - sore left arm; Sore left armpit; Swollen left armpit; 1 day - body aches; Headache; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26Dec2021 at 14:00 (Lot number: FJ8762) at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications included: MICROGESTIN; DAILY VITAMIN; ZINC and VITAMIN C. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0187, Anatomical Location: Left arm, Administration time: 16:00), administration date: 27May2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0181, Anatomical Location: Left arm, Administration time: 16:00), administration date: 17Jun2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (30Dec2021), described as "For 4 days - sore left arm"; AXILLARY PAIN (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (30Dec2021), described as "Sore left armpit"; SWELLING (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (30Dec2021), described as "Swollen left armpit"; PAIN (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (27Dec2021), described as "1 day - body aches"; HEADACHE (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (27Dec2021), described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, axillary pain, swelling, pain and headache.  Additional Information: The duration of the events PAIN and HEADACHE was reported as 1 day while that of the events PAIN IN EXTREMITY, AXILLARY PAIN, SWELLING was reported as 4 days. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: For 4 days - sore left arm; Sore left armpit; Swollen left armpit; 1 day - body aches; Headache; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26Dec2021 at 14:00 (Lot number: FJ8762) at the age of 29 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medications included: MICROGESTIN; DAILY VITAMIN; ZINC and VITAMIN C. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0187, Anatomical Location: Left arm, Administration time: 16:00), administration date: 27May2021, when the patient was 29 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0181, Anatomical Location: Left arm, Administration time: 16:00), administration date: 17Jun2021, when the patient was 29 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (30Dec2021), described as "For 4 days - sore left arm"; AXILLARY PAIN (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (30Dec2021), described as "Sore left armpit"; SWELLING (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (30Dec2021), described as "Swollen left armpit"; PAIN (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (27Dec2021), described as "1 day - body aches"; HEADACHE (non-serious) with onset 26Dec2021 at 22:00, outcome "recovered" (27Dec2021), described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, axillary pain, swelling, pain and headache.  Additional Information: The duration of the events PAIN and HEADACHE was reported as 1 day while that of the events PAIN IN EXTREMITY, AXILLARY PAIN, SWELLING was reported as 4 days. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.