chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Dizziness, Hallucination, visual, Hypopnoea
Clinical narrative: visual hallucinations; cough; shallow breathing; rash on neck, rash in left abdomen; feeling dizzy like too much oxygen to brain; panic attacks; symptoms of mania; lack of sleep; pressured speech; Temp 101.2; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ek6730, Intramuscular in left arm on 26Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included Autoimmune hypothyroidism, autoimmune ulcerative colitis, Raynauds phenomenon, mitral valve prolapse mild, right sided kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID), mesalamine, folic acid (FOLATE) and curcuma longa (TURMERIC). The patient previously received Sulfa and experienced rash. The patient had Temp 101.2, cough, shallow breathing, rash on neck, rash in left abdomen, feeling dizzy like too much oxygen to brain, panic attacks, visual hallucinations, symptoms of mania (lack of sleep, pressured speech) on 02Jan2021 07:30. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Lamictal, Zyprexa, clonazepam, propranolol, Norvasc. The patient had no Covid prior vaccination. The patient had covid tested post vaccination. Lab data included Nasal Swab Negative on 07Jan2021. The outcome of all events was resolving.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of visual hallucinations cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Mania, Panic attack, Pressure of speech, Pyrexia
Clinical narrative: visual hallucinations; cough; shallow breathing; rash on neck, rash in left abdomen; feeling dizzy like too much oxygen to brain; panic attacks; symptoms of mania; lack of sleep; pressured speech; Temp 101.2; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ek6730, Intramuscular in left arm on 26Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included Autoimmune hypothyroidism, autoimmune ulcerative colitis, Raynauds phenomenon, mitral valve prolapse mild, right sided kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID), mesalamine, folic acid (FOLATE) and curcuma longa (TURMERIC). The patient previously received Sulfa and experienced rash. The patient had Temp 101.2, cough, shallow breathing, rash on neck, rash in left abdomen, feeling dizzy like too much oxygen to brain, panic attacks, visual hallucinations, symptoms of mania (lack of sleep, pressured speech) on 02Jan2021 07:30. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Lamictal, Zyprexa, clonazepam, propranolol, Norvasc. The patient had no Covid prior vaccination. The patient had covid tested post vaccination. Lab data included Nasal Swab Negative on 07Jan2021. The outcome of all events was resolving.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of visual hallucinations cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: visual hallucinations; cough; shallow breathing; rash on neck, rash in left abdomen; feeling dizzy like too much oxygen to brain; panic attacks; symptoms of mania; lack of sleep; pressured speech; Temp 101.2; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ek6730, Intramuscular in left arm on 26Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included Autoimmune hypothyroidism, autoimmune ulcerative colitis, Raynauds phenomenon, mitral valve prolapse mild, right sided kidney stones. Concomitant medications included levothyroxine sodium (SYNTHROID), mesalamine, folic acid (FOLATE) and curcuma longa (TURMERIC). The patient previously received Sulfa and experienced rash. The patient had Temp 101.2, cough, shallow breathing, rash on neck, rash in left abdomen, feeling dizzy like too much oxygen to brain, panic attacks, visual hallucinations, symptoms of mania (lack of sleep, pressured speech) on 02Jan2021 07:30. All events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the events included Lamictal, Zyprexa, clonazepam, propranolol, Norvasc. The patient had no Covid prior vaccination. The patient had covid tested post vaccination. Lab data included Nasal Swab Negative on 07Jan2021. The outcome of all events was resolving.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of visual hallucinations cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood glucose normal, Blood pressure increased, Blood pressure measurement, Depressed level of consciousness
Clinical narrative: not aware of her surroundings; Rise in Blood Pressure to 215/92/133; During injection felt buring going in; body weakness; nausea; This is a spontaneous report from a contactable consumer (patient).  A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at left arm on 30Jan2021 13:00 at single dose for COVID-19 immunization. Facility where the COVID-19 vaccine was administered: Other. The patient's medical history included diabetes ("disabites"), high blood pressure, high cholesterol and old age ailments. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included alendronate sodium (ALENDRONATE), atorvastatin, clonidine, and clopidogrel. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril, amlodipine and, aspirin and experienced drug allergy (allergies to medications, food, or other products: Lisinopril, amlodipine, aspirin). On 30Jan2021 13:30, the patient experienced during injection felt burning ("buring") going in, rise in blood pressure (BP) to 215/92/133, body weakness, nausea and not aware of her surroundings. Ambulance available to monitor BP. The outcome of the events was recovered (in Jan2021). The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: not aware of her surroundings; Rise in Blood Pressure to 215/92/133; During injection felt buring going in; body weakness; nausea; This is a spontaneous report from a contactable consumer (patient).  A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at left arm on 30Jan2021 13:00 at single dose for COVID-19 immunization. Facility where the COVID-19 vaccine was administered: Other. The patient's medical history included diabetes ("disabites"), high blood pressure, high cholesterol and old age ailments. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included alendronate sodium (ALENDRONATE), atorvastatin, clonidine, and clopidogrel. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril, amlodipine and, aspirin and experienced drug allergy (allergies to medications, food, or other products: Lisinopril, amlodipine, aspirin). On 30Jan2021 13:30, the patient experienced during injection felt burning ("buring") going in, rise in blood pressure (BP) to 215/92/133, body weakness, nausea and not aware of her surroundings. Ambulance available to monitor BP. The outcome of the events was recovered (in Jan2021). The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Asthenia, Blood pressure measurement, Hypertension, Nausea
Clinical narrative: not aware of her surroundings; Rise in Blood Pressure to 215/92/133; During injection felt buring going in; body weakness; nausea; This is a spontaneous report from a contactable consumer (patient).  A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at left arm on 30Jan2021 13:00 at single dose for COVID-19 immunization. Facility where the COVID-19 vaccine was administered: Other. The patient's medical history included diabetes ("disabites"), high blood pressure, high cholesterol and old age ailments. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included alendronate sodium (ALENDRONATE), atorvastatin, clonidine, and clopidogrel. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril, amlodipine and, aspirin and experienced drug allergy (allergies to medications, food, or other products: Lisinopril, amlodipine, aspirin). On 30Jan2021 13:30, the patient experienced during injection felt burning ("buring") going in, rise in blood pressure (BP) to 215/92/133, body weakness, nausea and not aware of her surroundings. Ambulance available to monitor BP. The outcome of the events was recovered (in Jan2021). The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: not aware of her surroundings; Rise in Blood Pressure to 215/92/133; During injection felt buring going in; body weakness; nausea; This is a spontaneous report from a contactable consumer (patient).  A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at left arm on 30Jan2021 13:00 at single dose for COVID-19 immunization. Facility where the COVID-19 vaccine was administered: Other. The patient's medical history included diabetes ("disabites"), high blood pressure, high cholesterol and old age ailments. Concomitant medication (list of any other medications the patient received within 2 weeks of vaccination) included alendronate sodium (ALENDRONATE), atorvastatin, clonidine, and clopidogrel. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril, amlodipine and, aspirin and experienced drug allergy (allergies to medications, food, or other products: Lisinopril, amlodipine, aspirin). On 30Jan2021 13:30, the patient experienced during injection felt burning ("buring") going in, rise in blood pressure (BP) to 215/92/133, body weakness, nausea and not aware of her surroundings. Ambulance available to monitor BP. The outcome of the events was recovered (in Jan2021). The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: Immediate onset back tingling.  Later that day had sense of throat fullness.  2 days after vaccination had worsening throat fullness such that could not swallow.  Seen at outside ED and got epinephrine with prompt improvement
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Pyrexia, Throat irritation, Urticaria
Clinical narrative: Immediate onset back tingling.  Later that day had sense of throat fullness.  2 days after vaccination had worsening throat fullness such that could not swallow.  Seen at outside ED and got epinephrine with prompt improvement
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Paraesthesia, Pharyngeal swelling
Clinical narrative: Immediate onset back tingling.  Later that day had sense of throat fullness.  2 days after vaccination had worsening throat fullness such that could not swallow.  Seen at outside ED and got epinephrine with prompt improvement
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Impaired work ability, Throat tightness
Clinical narrative: Moderna COVID-19 Vaccine EUA
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, No adverse event
Clinical narrative: Moderna COVID-19 Vaccine EUA
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Electrocardiogram normal, Fatigue, Heart rate increased, Laboratory test normal
Clinical narrative: rash all over body; Low grade fever; fatigue; dizziness; increased heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Lot number: EL9262), intramuscular at the left arm on 26Jan2021 00:45 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included allergies: penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol (YASMIN), echinacea, dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), guaifenesin (ROBITUSSIN). The patient previously took amoxicillin and experienced allergies. Historical vaccine includes first dose of bnt162b2, lot number: EL0142, on 05Jan2021 10: 45 AM, intramuscular at the left arm for COVID-19 immunization at the age of 41 years. On 27Jan2021 at 12:00 pm, the patient experienced low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body. The events resulted to Emergency room/department or urgent care visit. IV fluids were given as treatment. Tests done with unknown results on Jan2021: Blood draw, ECG. The events were assessed by the reporter as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body was not recovered.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body, and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Urine analysis normal
Clinical narrative: rash all over body; Low grade fever; fatigue; dizziness; increased heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Lot number: EL9262), intramuscular at the left arm on 26Jan2021 00:45 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included allergies: penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol (YASMIN), echinacea, dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), guaifenesin (ROBITUSSIN). The patient previously took amoxicillin and experienced allergies. Historical vaccine includes first dose of bnt162b2, lot number: EL0142, on 05Jan2021 10: 45 AM, intramuscular at the left arm for COVID-19 immunization at the age of 41 years. On 27Jan2021 at 12:00 pm, the patient experienced low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body. The events resulted to Emergency room/department or urgent care visit. IV fluids were given as treatment. Tests done with unknown results on Jan2021: Blood draw, ECG. The events were assessed by the reporter as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body was not recovered.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body, and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Fatigue, Heart rate
Clinical narrative: rash all over body; Low grade fever; fatigue; dizziness; increased heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Lot number: EL9262), intramuscular at the left arm on 26Jan2021 00:45 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included allergies: penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol (YASMIN), echinacea, dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), guaifenesin (ROBITUSSIN). The patient previously took amoxicillin and experienced allergies. Historical vaccine includes first dose of bnt162b2, lot number: EL0142, on 05Jan2021 10: 45 AM, intramuscular at the left arm for COVID-19 immunization at the age of 41 years. On 27Jan2021 at 12:00 pm, the patient experienced low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body. The events resulted to Emergency room/department or urgent care visit. IV fluids were given as treatment. Tests done with unknown results on Jan2021: Blood draw, ECG. The events were assessed by the reporter as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body was not recovered.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body, and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pyrexia, Rash
Clinical narrative: rash all over body; Low grade fever; fatigue; dizziness; increased heart rate; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Lot number: EL9262), intramuscular at the left arm on 26Jan2021 00:45 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included allergies: penicillin. The patient was not pregnant at the time of vaccination. Concomitant medication included drospirenone, ethinylestradiol (YASMIN), echinacea, dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), guaifenesin (ROBITUSSIN). The patient previously took amoxicillin and experienced allergies. Historical vaccine includes first dose of bnt162b2, lot number: EL0142, on 05Jan2021 10: 45 AM, intramuscular at the left arm for COVID-19 immunization at the age of 41 years. On 27Jan2021 at 12:00 pm, the patient experienced low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body. The events resulted to Emergency room/department or urgent care visit. IV fluids were given as treatment. Tests done with unknown results on Jan2021: Blood draw, ECG. The events were assessed by the reporter as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body was not recovered.; Sender's Comments: Based on the plausible temporal association and considering lacking alternative explanations, the Company cannot completely exclude the possible causality between the reported events, low-grade fever, fatigue, dizziness, increased heart rate, and rash all over body, and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Chills, Decreased appetite
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Groin pain, Headache, Imaging procedure, Impaired work ability
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Laboratory test, Mobility decreased, Muscle tightness, Musculoskeletal chest pain
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Pulmonary embolism, Pyrexia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chest X-ray, Computerised tomogram, Decreased appetite
Clinical narrative: two pulmonary embolisms in right lung/Found old pulmonary embolism in left lung; pain moved up bilaterally to her arms, neck and jaw; pain in neck; pain moved up bilaterally to her arms, neck and jaw; wasn't able to ambulate independently; Rib pain; temperature of 101.8; significant decrease in appetite; unusual pain in her legs, hips and lower back; A spontaneous report was received from a nurse concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced unusual pain in her legs, hips, lower back, pain in both arms, neck  jaw and ribs, decrease in appetite, fever,  and pulmonary embolism.   The patient's medical history was not provided.  Concomitant medications included levothyroxine, prednisone, tizanidine and apixaban.   On 30-Dec-2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 011J20A) intramuscularly  for prophylaxis of COVID-19 infection and patient had a sore arm, muscle aches and slight headaches.  On 25-Jan-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-Feb-2021 the patient started developing an unusual pain in her legs, hips, and lower back that eventually moved up to her arms, neck and jaw. She reported that she had a significant decrease in appetite that Saturday, 06-Feb-2021, and on  07-Feb-2021, she had a temperature of 101.8.  She reported feeling like she had the flu.  Patient reported having a COVID-19 test that came back negative.  The pain continued to increase between Sunday night and Tuesday morning.  Patient then developed pain in her ribs when she would lay down. She wasn't able to ambulate independently. On 09-Feb-2021, she went to the hospital. They did a chest X-ray and computed tomography (CT) scan. Those tests showed two new pulmonary embolisms in the right lung and an old pulmonary embolism in the left lung. Patient was hospitalized 09-FEb-2021 until 12-Feb-2021.  She reported that her body was still inflamed. In her labs it showed her thyroid levels had doubled from her previously good thyroid levels checked in Oct 2020.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, pain in her legs, hips, lower back, neck, jaw  bilateral arm pain, decrease in appetite, fever, pain in ribs and pulmonary embolism, were considered controlled with medication.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.