chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Death, Dyspnoea, Thrombosis, Ultrasound scan abnormal
Clinical narrative: The patient had blood clots in arms that went to lung; The patient had blood clots in arms that went to lung; stopped breathing; This is a spontaneous report from a contactable consumer (patient's wife). A 38-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 22Sep2021 (Lot Number: 30135DA) as dose 2, single at the age of 38 years old for COVID-19 immunization. Medical history included ongoing asthma diagnosed as a kid. There were no concomitant medications. Historic vaccine was bnt162b2 administered in right arm on 25Aug2021 (lot: FC3183) as dose 1, single at the age of 37 years old for COVID-19 Immunization. The patient worked and was on the do not vaccinate list. Someone mandated all employees to be vaccinated. The patient was on the do not vaccinate list but was denied by his workplace. The patient's workplace approved others to not be vaccinated. The patient told the workplace receiving the vaccine was against his religious beliefs and the workplace denied the patient. Before the patient received the Pfizer Vaccine, the caller told her husband not to get the Pfizer Vaccine. The caller was also going to get the Pfizer Vaccine. Cause of death: The patient had blood clots in arms that went to lung. The blood clots formed a cluster when the paramedic was doing CPR, when the patient stopped breathing. The patient had fresh blood clots in the arms. Autopsy details available: The caller stated the autopsy details will be available in a few days. Someone told the caller, someone believed the patient's death was a reaction to the Pfizer Vaccine. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient died on 27Sep2021. An autopsy was performed and results were not provided. The outcome of events was fatal.; Reported Cause(s) of Death: The patient had blood clots in arms that went to lung; The patient had blood clots in arms that went to lung; stopped breathing
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Respiratory arrest, Thrombosis
Clinical narrative: The patient had blood clots in arms that went to lung; The patient had blood clots in arms that went to lung; stopped breathing; This is a spontaneous report from a contactable consumer (patient's wife). A 38-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 22Sep2021 (Lot Number: 30135DA) as dose 2, single at the age of 38 years old for COVID-19 immunization. Medical history included ongoing asthma diagnosed as a kid. There were no concomitant medications. Historic vaccine was bnt162b2 administered in right arm on 25Aug2021 (lot: FC3183) as dose 1, single at the age of 37 years old for COVID-19 Immunization. The patient worked and was on the do not vaccinate list. Someone mandated all employees to be vaccinated. The patient was on the do not vaccinate list but was denied by his workplace. The patient's workplace approved others to not be vaccinated. The patient told the workplace receiving the vaccine was against his religious beliefs and the workplace denied the patient. Before the patient received the Pfizer Vaccine, the caller told her husband not to get the Pfizer Vaccine. The caller was also going to get the Pfizer Vaccine. Cause of death: The patient had blood clots in arms that went to lung. The blood clots formed a cluster when the paramedic was doing CPR, when the patient stopped breathing. The patient had fresh blood clots in the arms. Autopsy details available: The caller stated the autopsy details will be available in a few days. Someone told the caller, someone believed the patient's death was a reaction to the Pfizer Vaccine. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient died on 27Sep2021. An autopsy was performed and results were not provided. The outcome of events was fatal.; Reported Cause(s) of Death: The patient had blood clots in arms that went to lung; The patient had blood clots in arms that went to lung; stopped breathing
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling hot, Hypoaesthesia oral, Pharyngeal swelling, Pruritus
Clinical narrative: Tremors and body shaking; itching; numbness in the mouth; flushing; localizing or generalized urticaria; swelling of the mouth and throat; swelling of the mouth and throat; abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (pregnant no) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 39-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: 30135BA) as SINGLE for covid-19 immunisation. Medical history included Sjogrens Syndrome, Fibromyalgia and hypoglicemic, Allergies Sulfa. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; tizanidine taken for an unspecified indication, start and stop date were not reported. The patient previously took acyclovir, valtrex and prozac and all experienced allergy. The patient experienced Tremors and body shaking, itching, numbness in the mouth, flushing, localizing or generalized urticaria, swelling of the mouth and throat, abdominal pain, headache, all on 08Oct2021 14:15 with outcome of recovering. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was Benadryl 25mg (2 pills). Serious: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rhinorrhoea, Tremor, Urticaria
Clinical narrative: Tremors and body shaking; itching; numbness in the mouth; flushing; localizing or generalized urticaria; swelling of the mouth and throat; swelling of the mouth and throat; abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (pregnant no) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 39-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: 30135BA) as SINGLE for covid-19 immunisation. Medical history included Sjogrens Syndrome, Fibromyalgia and hypoglicemic, Allergies Sulfa. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; tizanidine taken for an unspecified indication, start and stop date were not reported. The patient previously took acyclovir, valtrex and prozac and all experienced allergy. The patient experienced Tremors and body shaking, itching, numbness in the mouth, flushing, localizing or generalized urticaria, swelling of the mouth and throat, abdominal pain, headache, all on 08Oct2021 14:15 with outcome of recovering. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was Benadryl 25mg (2 pills). Serious: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Flushing, Headache, Hypoaesthesia oral, Mouth swelling
Clinical narrative: Tremors and body shaking; itching; numbness in the mouth; flushing; localizing or generalized urticaria; swelling of the mouth and throat; swelling of the mouth and throat; abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (pregnant no) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 39-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: 30135BA) as SINGLE for covid-19 immunisation. Medical history included Sjogrens Syndrome, Fibromyalgia and hypoglicemic, Allergies Sulfa. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; tizanidine taken for an unspecified indication, start and stop date were not reported. The patient previously took acyclovir, valtrex and prozac and all experienced allergy. The patient experienced Tremors and body shaking, itching, numbness in the mouth, flushing, localizing or generalized urticaria, swelling of the mouth and throat, abdominal pain, headache, all on 08Oct2021 14:15 with outcome of recovering. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was Benadryl 25mg (2 pills). Serious: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Tremor, Urticaria
Clinical narrative: Tremors and body shaking; itching; numbness in the mouth; flushing; localizing or generalized urticaria; swelling of the mouth and throat; swelling of the mouth and throat; abdominal pain; headache; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (pregnant no) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 39-years-old, dose 1 via an unspecified route of administration, administered in Arm Left on 08Oct2021 13:00 (Lot Number: 30135BA) as SINGLE for covid-19 immunisation. Medical history included Sjogrens Syndrome, Fibromyalgia and hypoglicemic, Allergies Sulfa. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; tizanidine taken for an unspecified indication, start and stop date were not reported. The patient previously took acyclovir, valtrex and prozac and all experienced allergy. The patient experienced Tremors and body shaking, itching, numbness in the mouth, flushing, localizing or generalized urticaria, swelling of the mouth and throat, abdominal pain, headache, all on 08Oct2021 14:15 with outcome of recovering. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment was Benadryl 25mg (2 pills). Serious: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt admitted to the hospital with confusion, fatigue, "rattling breath sounds"; test for COVID is position; started on 2L O2 and steroids, pt's O2 requirements continued to increase while in the hospital; palliative care and eventually comfort measures only were instituted; pt died in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Breath sounds abnormal, COVID-19, Confusional state, Death, Fatigue
Clinical narrative: pt admitted to the hospital with confusion, fatigue, "rattling breath sounds"; test for COVID is position; started on 2L O2 and steroids, pt's O2 requirements continued to increase while in the hospital; palliative care and eventually comfort measures only were instituted; pt died in the hospital
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: pt admitted to the hospital with confusion, fatigue, "rattling breath sounds"; test for COVID is position; started on 2L O2 and steroids, pt's O2 requirements continued to increase while in the hospital; palliative care and eventually comfort measures only were instituted; pt died in the hospital
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Extra dose administered, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: a fever of 101.8 for 48 hours post injection; pain on the arm; Severe under arm swelling (lymph nodes); This is a spontaneous report from a contactable Other Health Professional (patient). A non-pregnant 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 intramuscular, administered in right arm on 08Oct2021 (at age of 28 years old, no pregnant at time of vaccination, Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included known allergies: penicillin. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose of via intramuscular administered in right arm on 18Dec2020 (at age of 27 years old), the second dose via intramuscular administered in left arm on 08Jan2021 (at age of 28 years old) as single dose for covid-19 immunization. On 08Oct2021 at 21:00, the patient experienced severe under arm swelling (lymphnodes) and pain on the arm given the injection, this reaction was singular only to the booster shot received in addition a fever of 101.8 for 48 hours post injection on 10Oct2021. The patient underwent lab tests and procedures which included Covid test Nasal Swab: negative on 09Oct2021. The patient not received treatment. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: a fever of 101.8 for 48 hours post injection; pain on the arm; Severe under arm swelling (lymph nodes); This is a spontaneous report from a contactable Other Health Professional (patient). A non-pregnant 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 intramuscular, administered in right arm on 08Oct2021 (at age of 28 years old, no pregnant at time of vaccination, Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included known allergies: penicillin. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose of via intramuscular administered in right arm on 18Dec2020 (at age of 27 years old), the second dose via intramuscular administered in left arm on 08Jan2021 (at age of 28 years old) as single dose for covid-19 immunization. On 08Oct2021 at 21:00, the patient experienced severe under arm swelling (lymphnodes) and pain on the arm given the injection, this reaction was singular only to the booster shot received in addition a fever of 101.8 for 48 hours post injection on 10Oct2021. The patient underwent lab tests and procedures which included Covid test Nasal Swab: negative on 09Oct2021. The patient not received treatment. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Lymphadenopathy, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: a fever of 101.8 for 48 hours post injection; pain on the arm; Severe under arm swelling (lymph nodes); This is a spontaneous report from a contactable Other Health Professional (patient). A non-pregnant 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 intramuscular, administered in right arm on 08Oct2021 (at age of 28 years old, no pregnant at time of vaccination, Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included known allergies: penicillin. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) the first dose of via intramuscular administered in right arm on 18Dec2020 (at age of 27 years old), the second dose via intramuscular administered in left arm on 08Jan2021 (at age of 28 years old) as single dose for covid-19 immunization. On 08Oct2021 at 21:00, the patient experienced severe under arm swelling (lymphnodes) and pain on the arm given the injection, this reaction was singular only to the booster shot received in addition a fever of 101.8 for 48 hours post injection on 10Oct2021. The patient underwent lab tests and procedures which included Covid test Nasal Swab: negative on 09Oct2021. The patient not received treatment. The outcome of the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Urticaria
Clinical narrative: I have been using this since the beginning of summer and I have psoriasis and I thought it was that at first then I recieved my second covid vaccine and had a flu shot along with my first one I have had the worst symptoms after second vaccination I was at death's door and back but the hives or rash seems to stay the same I can't get rid of it peeling and itching on my entire face neck all the way down to my breast now and 2 new spots show up on the back of my thighs this has been getting worse for over a month and I contacted Pharmacy and was told if my breathing was not compromised just take benadryl and that doesn't seem to help just makes me sleep all day and I keep doing a back and forth thing where I'm fine and then I'm sick again my appetite is not near what it was I can't handle anything sweet and I just want to know if it's the spray or the vaccine or both or the combination of all 3. I have a doctor appointment on the third and I need to know what I should do when I go there to fix this situation I look like a monster and I am afraid it's going to scar for life.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Malaise, Pruritus, Rash, Skin exfoliation
Clinical narrative: I have been using this since the beginning of summer and I have psoriasis and I thought it was that at first then I recieved my second covid vaccine and had a flu shot along with my first one I have had the worst symptoms after second vaccination I was at death's door and back but the hives or rash seems to stay the same I can't get rid of it peeling and itching on my entire face neck all the way down to my breast now and 2 new spots show up on the back of my thighs this has been getting worse for over a month and I contacted Pharmacy and was told if my breathing was not compromised just take benadryl and that doesn't seem to help just makes me sleep all day and I keep doing a back and forth thing where I'm fine and then I'm sick again my appetite is not near what it was I can't handle anything sweet and I just want to know if it's the spray or the vaccine or both or the combination of all 3. I have a doctor appointment on the third and I need to know what I should do when I go there to fix this situation I look like a monster and I am afraid it's going to scar for life.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram thorax, Lung opacity, Oxygen saturation decreased
Clinical narrative: Previously submitted data on this patient, E report #679858 submitting f/u information.  Pt expired 10/28/2021  PRINCIPAL DIAGNOSIS COVID-19 Infection   SECONDARY DIAGNOSES Principal Problem:   COVID-19 Infection Active Problems:   Pneumonia Due To COVID-19   Leukemia Lymphocytic Chronic Not Having Achieved Remission (HCC)   Acute Respiratory Failure With Hypoxia (HCC)   Leukemia Lymphocytic Chronic In Relapse (HCC)   Chronic Kidney Disease (CKD), Stage 3b Glomerular Filtration Rate (GFR) 30 To 44 (HCC)   Thrombocytopenia (HCC)   Depression Major Recurrent Partial Remission (HCC)   PreDiabetes   Hypertension Essential Primary   Hypogammaglobulinemia (HCC)   Decline Functional Status   Depression Major Recurrent (HCC)   Shortness Of Breath
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Previously submitted data on this patient, E report #679858 submitting f/u information.  Pt expired 10/28/2021  PRINCIPAL DIAGNOSIS COVID-19 Infection   SECONDARY DIAGNOSES Principal Problem:   COVID-19 Infection Active Problems:   Pneumonia Due To COVID-19   Leukemia Lymphocytic Chronic Not Having Achieved Remission (HCC)   Acute Respiratory Failure With Hypoxia (HCC)   Leukemia Lymphocytic Chronic In Relapse (HCC)   Chronic Kidney Disease (CKD), Stage 3b Glomerular Filtration Rate (GFR) 30 To 44 (HCC)   Thrombocytopenia (HCC)   Depression Major Recurrent Partial Remission (HCC)   PreDiabetes   Hypertension Essential Primary   Hypogammaglobulinemia (HCC)   Decline Functional Status   Depression Major Recurrent (HCC)   Shortness Of Breath
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Glomerular filtration rate decreased
Clinical narrative: Previously submitted data on this patient, E report #679858 submitting f/u information.  Pt expired 10/28/2021  PRINCIPAL DIAGNOSIS COVID-19 Infection   SECONDARY DIAGNOSES Principal Problem:   COVID-19 Infection Active Problems:   Pneumonia Due To COVID-19   Leukemia Lymphocytic Chronic Not Having Achieved Remission (HCC)   Acute Respiratory Failure With Hypoxia (HCC)   Leukemia Lymphocytic Chronic In Relapse (HCC)   Chronic Kidney Disease (CKD), Stage 3b Glomerular Filtration Rate (GFR) 30 To 44 (HCC)   Thrombocytopenia (HCC)   Depression Major Recurrent Partial Remission (HCC)   PreDiabetes   Hypertension Essential Primary   Hypogammaglobulinemia (HCC)   Decline Functional Status   Depression Major Recurrent (HCC)   Shortness Of Breath
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Client complained of itchy, red bumps on left arm after vaccine administration. Benadryl administered. No other symptoms observed. Client felt better after 30 minutes observation period.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Client complained of itchy, red bumps on left arm after vaccine administration. Benadryl administered. No other symptoms observed. Client felt better after 30 minutes observation period.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: 4 hours later in the morning "my" temperature was 99.7; All "my" bones and muscles were aching; All "my" bones and muscles were aching; Within 2 hours of receiving "my" second dose of vaccine "I" started getting headache; General body ache; That night "I" woke after 3hours of sleep feeling cold and checking "my" temperature it was 96.8; And now a week later "I" still hurt in my joints. It isworry some and painful.; This is a spontaneous report from a contactable consumer, the patient. A male patient of (18-64 Years) unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 13:15 as a single dose for COVID-19 immunisation. Medical history was not report. The patient had known allergies to aspirin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included certalene (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 as a single dose for COVID-19 immunisation. On 04May2021 at 15:30 (reported as within 2 hours), the patient experienced getting headache and general body ache. On the same day at night, he woke up after 3 hours of sleep feeling cold and checking his body temperature which was found to be 96.8 (units unspecified). On 05May2021, 4 hours later in the morning, the patient again checked his body temperature test and result was found to be 99.7 (units unspecified). On the same day, the patient also experienced all his bones and muscle were aching. The patient reported that he checked to see if he should be alarm and found out the second dose does cause some reactions. The patient also reported that 48 hours after the shot most of his aches subsided but bone aches persisted. On an unknown date in May2021, the patient also experienced joint ache which were still hurting a week later and were worry some and painful. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, generalised aching, feeling cold, body temperature increased, bone pain, muscle ache and joint pain and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and general body ache, feeling cold, body temperature increased, bone pain and muscle pain were recovered/resolved with sequelae; whereas joint pain was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Bone pain, Feeling cold
Clinical narrative: 4 hours later in the morning "my" temperature was 99.7; All "my" bones and muscles were aching; All "my" bones and muscles were aching; Within 2 hours of receiving "my" second dose of vaccine "I" started getting headache; General body ache; That night "I" woke after 3hours of sleep feeling cold and checking "my" temperature it was 96.8; And now a week later "I" still hurt in my joints. It isworry some and painful.; This is a spontaneous report from a contactable consumer, the patient. A male patient of (18-64 Years) unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 13:15 as a single dose for COVID-19 immunisation. Medical history was not report. The patient had known allergies to aspirin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included certalene (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 as a single dose for COVID-19 immunisation. On 04May2021 at 15:30 (reported as within 2 hours), the patient experienced getting headache and general body ache. On the same day at night, he woke up after 3 hours of sleep feeling cold and checking his body temperature which was found to be 96.8 (units unspecified). On 05May2021, 4 hours later in the morning, the patient again checked his body temperature test and result was found to be 99.7 (units unspecified). On the same day, the patient also experienced all his bones and muscle were aching. The patient reported that he checked to see if he should be alarm and found out the second dose does cause some reactions. The patient also reported that 48 hours after the shot most of his aches subsided but bone aches persisted. On an unknown date in May2021, the patient also experienced joint ache which were still hurting a week later and were worry some and painful. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, generalised aching, feeling cold, body temperature increased, bone pain, muscle ache and joint pain and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and general body ache, feeling cold, body temperature increased, bone pain and muscle pain were recovered/resolved with sequelae; whereas joint pain was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: 4 hours later in the morning "my" temperature was 99.7; All "my" bones and muscles were aching; All "my" bones and muscles were aching; Within 2 hours of receiving "my" second dose of vaccine "I" started getting headache; General body ache; That night "I" woke after 3hours of sleep feeling cold and checking "my" temperature it was 96.8; And now a week later "I" still hurt in my joints. It isworry some and painful.; This is a spontaneous report from a contactable consumer, the patient. A male patient of (18-64 Years) unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 13:15 as a single dose for COVID-19 immunisation. Medical history was not report. The patient had known allergies to aspirin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included certalene (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Apr2021 at 13:15 as a single dose for COVID-19 immunisation. On 04May2021 at 15:30 (reported as within 2 hours), the patient experienced getting headache and general body ache. On the same day at night, he woke up after 3 hours of sleep feeling cold and checking his body temperature which was found to be 96.8 (units unspecified). On 05May2021, 4 hours later in the morning, the patient again checked his body temperature test and result was found to be 99.7 (units unspecified). On the same day, the patient also experienced all his bones and muscle were aching. The patient reported that he checked to see if he should be alarm and found out the second dose does cause some reactions. The patient also reported that 48 hours after the shot most of his aches subsided but bone aches persisted. On an unknown date in May2021, the patient also experienced joint ache which were still hurting a week later and were worry some and painful. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache, generalised aching, feeling cold, body temperature increased, bone pain, muscle ache and joint pain and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and general body ache, feeling cold, body temperature increased, bone pain and muscle pain were recovered/resolved with sequelae; whereas joint pain was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Injection site pain
Clinical narrative: LEFT ARM STARTED LOSING FEELING AND STRENGTH/LOST AROUND EIGHTY PERCENTAGE OF STRENGTH IN FINGERS; LEFT WRIST FOREARM FEELS NUMB  ALONG WITH REAR DELTOID MIDDLE DELTOID/RIGHT PINKY FEELING A BIT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, Laboratory data included: MRI (NR: not provided) Negative, Negative. On 14-OCT-2021, the patient experienced left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. On 14-OCT-2021, the patient experienced left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb, and left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Injection site pain, Lethargy, Magnetic resonance imaging head, Magnetic resonance imaging neck
Clinical narrative: LEFT ARM STARTED LOSING FEELING AND STRENGTH/LOST AROUND EIGHTY PERCENTAGE OF STRENGTH IN FINGERS; LEFT WRIST FOREARM FEELS NUMB  ALONG WITH REAR DELTOID MIDDLE DELTOID/RIGHT PINKY FEELING A BIT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, Laboratory data included: MRI (NR: not provided) Negative, Negative. On 14-OCT-2021, the patient experienced left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. On 14-OCT-2021, the patient experienced left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb, and left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Monoplegia, Muscle atrophy
Clinical narrative: LEFT ARM STARTED LOSING FEELING AND STRENGTH/LOST AROUND EIGHTY PERCENTAGE OF STRENGTH IN FINGERS; LEFT WRIST FOREARM FEELS NUMB  ALONG WITH REAR DELTOID MIDDLE DELTOID/RIGHT PINKY FEELING A BIT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, Laboratory data included: MRI (NR: not provided) Negative, Negative. On 14-OCT-2021, the patient experienced left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. On 14-OCT-2021, the patient experienced left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb, and left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia, Radiculitis brachial
Clinical narrative: LEFT ARM STARTED LOSING FEELING AND STRENGTH/LOST AROUND EIGHTY PERCENTAGE OF STRENGTH IN FINGERS; LEFT WRIST FOREARM FEELS NUMB  ALONG WITH REAR DELTOID MIDDLE DELTOID/RIGHT PINKY FEELING A BIT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, Laboratory data included: MRI (NR: not provided) Negative, Negative. On 14-OCT-2021, the patient experienced left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. On 14-OCT-2021, the patient experienced left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb, and left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: LEFT ARM STARTED LOSING FEELING AND STRENGTH/LOST AROUND EIGHTY PERCENTAGE OF STRENGTH IN FINGERS; LEFT WRIST FOREARM FEELS NUMB  ALONG WITH REAR DELTOID MIDDLE DELTOID/RIGHT PINKY FEELING A BIT NUMB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, Laboratory data included: MRI (NR: not provided) Negative, Negative. On 14-OCT-2021, the patient experienced left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. On 14-OCT-2021, the patient experienced left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left wrist forearm feels numb along with rear deltoid middle deltoid/right pinky feeling a bit numb, and left arm started losing feeling and strength/lost around eighty percentage of strength in fingers. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: swelling up the injection site; redness; lots of soreness; 4x4 discoloration area on her arm and underneath it; The lymph nodes under her arm became rock hard, and was the size of her palm; the symptoms are becoming worse each day; The area itched terribly it was warm and swollen.; This is a spontaneous report from a contactable other HCP (patient). A 79-year-old female patient received bnt162b2 (COMIRNATY), Dose 2 via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included allergy to chemicals from an unknown date and unknown if ongoing (PEG 2000), and a vocal cord issue that makes it hard to understand her. The patient's concomitant medications were not reported.  The patient previously took polysorbate 80 and experienced drug hypersensitivity. The patient previously received Dose 1 of bnt162b2 in Sep2021 for covid-19 immunisation and experienced sore arm for 3 days. The patient experienced swelling up the injection site on 02Oct2021, redness on 02Oct2021, lots of soreness on 02Oct2021, 4x4 discoloration area on her arm and underneath it on 02Oct2021, the lymph nodes under her arm became rock hard, and was the size of her palm (medically significant) in 02Oct2021, the symptoms are becoming worse each day (condition aggravated) (medically significant) in Oct2021, the area itched terribly it was warm and swollen in Oct2021. The patient reported she got the second dose on Friday 01Oct2021 and on Saturday, 02Oct2021, the swelling started at the injection site. By Wednesday 06Oct2021, the swelling had spread to the side. There was increased redness, and lots of soreness. She said there was a 4x4 discoloration area on her arm and underneath it. The lymph nodes under her arm became rock hard and was the size of her palm. She said the symptoms are becoming worse each day. That following Monday 10Oct2021, she saw the doctor and she put her on prednisone 40mg daily and the redness kept spreading. The area itched terribly it was warm and swollen. She is going to ask for an antibody test to see if the prednisone nullified the Covid-19 vaccine. She also mentioned that she got tested to check if she was allergic to PEG 2000, but it came back negative. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, the contributory role of the suspect product bnt162b2 (COMIRNATY), to reported events Lymphadenopathy and condition aggravated is possible. Case will be reassessed upon receipt of follow-up information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: swelling up the injection site; redness; lots of soreness; 4x4 discoloration area on her arm and underneath it; The lymph nodes under her arm became rock hard, and was the size of her palm; the symptoms are becoming worse each day; The area itched terribly it was warm and swollen.; This is a spontaneous report from a contactable other HCP (patient). A 79-year-old female patient received bnt162b2 (COMIRNATY), Dose 2 via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included allergy to chemicals from an unknown date and unknown if ongoing (PEG 2000), and a vocal cord issue that makes it hard to understand her. The patient's concomitant medications were not reported.  The patient previously took polysorbate 80 and experienced drug hypersensitivity. The patient previously received Dose 1 of bnt162b2 in Sep2021 for covid-19 immunisation and experienced sore arm for 3 days. The patient experienced swelling up the injection site on 02Oct2021, redness on 02Oct2021, lots of soreness on 02Oct2021, 4x4 discoloration area on her arm and underneath it on 02Oct2021, the lymph nodes under her arm became rock hard, and was the size of her palm (medically significant) in 02Oct2021, the symptoms are becoming worse each day (condition aggravated) (medically significant) in Oct2021, the area itched terribly it was warm and swollen in Oct2021. The patient reported she got the second dose on Friday 01Oct2021 and on Saturday, 02Oct2021, the swelling started at the injection site. By Wednesday 06Oct2021, the swelling had spread to the side. There was increased redness, and lots of soreness. She said there was a 4x4 discoloration area on her arm and underneath it. The lymph nodes under her arm became rock hard and was the size of her palm. She said the symptoms are becoming worse each day. That following Monday 10Oct2021, she saw the doctor and she put her on prednisone 40mg daily and the redness kept spreading. The area itched terribly it was warm and swollen. She is going to ask for an antibody test to see if the prednisone nullified the Covid-19 vaccine. She also mentioned that she got tested to check if she was allergic to PEG 2000, but it came back negative. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, the contributory role of the suspect product bnt162b2 (COMIRNATY), to reported events Lymphadenopathy and condition aggravated is possible. Case will be reassessed upon receipt of follow-up information.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: swelling up the injection site; redness; lots of soreness; 4x4 discoloration area on her arm and underneath it; The lymph nodes under her arm became rock hard, and was the size of her palm; the symptoms are becoming worse each day; The area itched terribly it was warm and swollen.; This is a spontaneous report from a contactable other HCP (patient). A 79-year-old female patient received bnt162b2 (COMIRNATY), Dose 2 via an unspecified route of administration on 01Oct2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included allergy to chemicals from an unknown date and unknown if ongoing (PEG 2000), and a vocal cord issue that makes it hard to understand her. The patient's concomitant medications were not reported.  The patient previously took polysorbate 80 and experienced drug hypersensitivity. The patient previously received Dose 1 of bnt162b2 in Sep2021 for covid-19 immunisation and experienced sore arm for 3 days. The patient experienced swelling up the injection site on 02Oct2021, redness on 02Oct2021, lots of soreness on 02Oct2021, 4x4 discoloration area on her arm and underneath it on 02Oct2021, the lymph nodes under her arm became rock hard, and was the size of her palm (medically significant) in 02Oct2021, the symptoms are becoming worse each day (condition aggravated) (medically significant) in Oct2021, the area itched terribly it was warm and swollen in Oct2021. The patient reported she got the second dose on Friday 01Oct2021 and on Saturday, 02Oct2021, the swelling started at the injection site. By Wednesday 06Oct2021, the swelling had spread to the side. There was increased redness, and lots of soreness. She said there was a 4x4 discoloration area on her arm and underneath it. The lymph nodes under her arm became rock hard and was the size of her palm. She said the symptoms are becoming worse each day. That following Monday 10Oct2021, she saw the doctor and she put her on prednisone 40mg daily and the redness kept spreading. The area itched terribly it was warm and swollen. She is going to ask for an antibody test to see if the prednisone nullified the Covid-19 vaccine. She also mentioned that she got tested to check if she was allergic to PEG 2000, but it came back negative. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, the contributory role of the suspect product bnt162b2 (COMIRNATY), to reported events Lymphadenopathy and condition aggravated is possible. Case will be reassessed upon receipt of follow-up information.