chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: felt weird; sore throat; cold like symptoms; tongue swole up; heart racing fast; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: unknown) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and high cholesterol. The patient had history of known allergies to shellfish, grass, some beans, fur animals and just about everything. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), simvastatin (MANUFACTURER UNKNOWN) and vitamins, all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Apr2021 at 13:00, the patient experienced felt weird, like a sore throat out of no where, cold like symptoms and then on that later evening tongue swole up and her heart was racing fast. The patient underwent lab tests and procedures, which included COVID test on an unknown date, which result was unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with diphenhydramine (BENADRYL). The clinical outcomes of felt weird, sore throat, cold like symptoms, tongue swole up and heart racing fast were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen left lymph nodes under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm left on 31Mar2021 at 12:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient had known allergy to sulfa (sulfonamide).  Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), sertraline (MANUFACTURER UNKNOWN) , gliclazide (CLARITIN) and paracetamol (TYLENOL) all from unknown date, for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00 the patient experienced swollen left lymph nodes under left armpit (swollen lymph nodes). No therapeutic measures were taken as a result of reported event . The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Malaise, Myalgia
Clinical narrative: Fever; Dizziness; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient was not allergic to medications, food, or other products. The patient did not  receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, at 03:00 the patient woke up in middle of the night with fever, dizziness, it progressed to vomiting for the last four hours and chills. Event fever and chills continued. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, dizziness, vomiting and chills was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; Dizziness; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient was not allergic to medications, food, or other products. The patient did not  receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, at 03:00 the patient woke up in middle of the night with fever, dizziness, it progressed to vomiting for the last four hours and chills. Event fever and chills continued. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, dizziness, vomiting and chills was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Pyrexia, Vomiting
Clinical narrative: Fever; Dizziness; Vomiting; Chills; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 14:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient was not allergic to medications, food, or other products. The patient did not  receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, at 03:00 the patient woke up in middle of the night with fever, dizziness, it progressed to vomiting for the last four hours and chills. Event fever and chills continued. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, dizziness, vomiting and chills was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood lactic acid increased, Computerised tomogram, Dyspnoea, Fibrin D dimer increased, Haemoglobin decreased
Clinical narrative: PULMONARY EMBOLISM; DID NOT FEEL GOOD; This spontaneous report received from a health care professional (nurse) concerned a 54 year old unspecified race and ethnic origin female. 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, and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: Hizentra (immunoglobulin human normal), (infusion, subcutaneous, batch number: Unknown and expiry; Unknown) 10 gram of weekly infusion, from 28-MAR-2021 for primary immunodeficiency. Concomitant medications included Tylenol (paracetamol) for unknown indication.  Earlier this year (unspecified date), after receiving Covid-19 vaccine (Johnson and Johnson), per patient, things started to spiral down. On 25-JUN-2021, the patient took previous infusion Hizentra. The patient did not feel good after the infusion but ignored these symptoms, which tends to be her state post infusion. On 27-JUN-2021, the patient was having mucus and started coughing blood. On the same day, she was sitting on her couch, and her watch alerted her of a tachycardia rhythm. The spouse took the patient to the emergency room (ER), where a computerised tomogram (CT) scan was ordered, and a blood clot (pulmonary embolism) in the lungs was confirmed. The patient did not confirm any hospital admission. Still, the physician for Hizentra decided to hold her infusions for four weeks to monitor the patient and let the new medication, Eliquis (anticoagulant), settle in the system. The patient adds that on the brighter side, her IgG levels were in the ideal range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and did not feel good was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210738853-covid-19 vaccine ad26.cov2.s -pulmonary embolism. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Impaired work ability, Injection site induration, Injection site mass, Injection site pain, Laboratory test
Clinical narrative: PULMONARY EMBOLISM; DID NOT FEEL GOOD; This spontaneous report received from a health care professional (nurse) concerned a 54 year old unspecified race and ethnic origin female. 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, and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: Hizentra (immunoglobulin human normal), (infusion, subcutaneous, batch number: Unknown and expiry; Unknown) 10 gram of weekly infusion, from 28-MAR-2021 for primary immunodeficiency. Concomitant medications included Tylenol (paracetamol) for unknown indication.  Earlier this year (unspecified date), after receiving Covid-19 vaccine (Johnson and Johnson), per patient, things started to spiral down. On 25-JUN-2021, the patient took previous infusion Hizentra. The patient did not feel good after the infusion but ignored these symptoms, which tends to be her state post infusion. On 27-JUN-2021, the patient was having mucus and started coughing blood. On the same day, she was sitting on her couch, and her watch alerted her of a tachycardia rhythm. The spouse took the patient to the emergency room (ER), where a computerised tomogram (CT) scan was ordered, and a blood clot (pulmonary embolism) in the lungs was confirmed. The patient did not confirm any hospital admission. Still, the physician for Hizentra decided to hold her infusions for four weeks to monitor the patient and let the new medication, Eliquis (anticoagulant), settle in the system. The patient adds that on the brighter side, her IgG levels were in the ideal range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and did not feel good was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210738853-covid-19 vaccine ad26.cov2.s -pulmonary embolism. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Laboratory test abnormal, Lactic acidosis, Liver function test decreased, Pain, Pain in extremity
Clinical narrative: PULMONARY EMBOLISM; DID NOT FEEL GOOD; This spontaneous report received from a health care professional (nurse) concerned a 54 year old unspecified race and ethnic origin female. 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, and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: Hizentra (immunoglobulin human normal), (infusion, subcutaneous, batch number: Unknown and expiry; Unknown) 10 gram of weekly infusion, from 28-MAR-2021 for primary immunodeficiency. Concomitant medications included Tylenol (paracetamol) for unknown indication.  Earlier this year (unspecified date), after receiving Covid-19 vaccine (Johnson and Johnson), per patient, things started to spiral down. On 25-JUN-2021, the patient took previous infusion Hizentra. The patient did not feel good after the infusion but ignored these symptoms, which tends to be her state post infusion. On 27-JUN-2021, the patient was having mucus and started coughing blood. On the same day, she was sitting on her couch, and her watch alerted her of a tachycardia rhythm. The spouse took the patient to the emergency room (ER), where a computerised tomogram (CT) scan was ordered, and a blood clot (pulmonary embolism) in the lungs was confirmed. The patient did not confirm any hospital admission. Still, the physician for Hizentra decided to hold her infusions for four weeks to monitor the patient and let the new medication, Eliquis (anticoagulant), settle in the system. The patient adds that on the brighter side, her IgG levels were in the ideal range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and did not feel good was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210738853-covid-19 vaccine ad26.cov2.s -pulmonary embolism. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pyrexia, Renal impairment, White blood cell count increased
Clinical narrative: PULMONARY EMBOLISM; DID NOT FEEL GOOD; This spontaneous report received from a health care professional (nurse) concerned a 54 year old unspecified race and ethnic origin female. 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, and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: Hizentra (immunoglobulin human normal), (infusion, subcutaneous, batch number: Unknown and expiry; Unknown) 10 gram of weekly infusion, from 28-MAR-2021 for primary immunodeficiency. Concomitant medications included Tylenol (paracetamol) for unknown indication.  Earlier this year (unspecified date), after receiving Covid-19 vaccine (Johnson and Johnson), per patient, things started to spiral down. On 25-JUN-2021, the patient took previous infusion Hizentra. The patient did not feel good after the infusion but ignored these symptoms, which tends to be her state post infusion. On 27-JUN-2021, the patient was having mucus and started coughing blood. On the same day, she was sitting on her couch, and her watch alerted her of a tachycardia rhythm. The spouse took the patient to the emergency room (ER), where a computerised tomogram (CT) scan was ordered, and a blood clot (pulmonary embolism) in the lungs was confirmed. The patient did not confirm any hospital admission. Still, the physician for Hizentra decided to hold her infusions for four weeks to monitor the patient and let the new medication, Eliquis (anticoagulant), settle in the system. The patient adds that on the brighter side, her IgG levels were in the ideal range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and did not feel good was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210738853-covid-19 vaccine ad26.cov2.s -pulmonary embolism. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood immunoglobulin G, Computerised tomogram, Malaise, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; DID NOT FEEL GOOD; This spontaneous report received from a health care professional (nurse) concerned a 54 year old unspecified race and ethnic origin female. 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, and batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: Hizentra (immunoglobulin human normal), (infusion, subcutaneous, batch number: Unknown and expiry; Unknown) 10 gram of weekly infusion, from 28-MAR-2021 for primary immunodeficiency. Concomitant medications included Tylenol (paracetamol) for unknown indication.  Earlier this year (unspecified date), after receiving Covid-19 vaccine (Johnson and Johnson), per patient, things started to spiral down. On 25-JUN-2021, the patient took previous infusion Hizentra. The patient did not feel good after the infusion but ignored these symptoms, which tends to be her state post infusion. On 27-JUN-2021, the patient was having mucus and started coughing blood. On the same day, she was sitting on her couch, and her watch alerted her of a tachycardia rhythm. The spouse took the patient to the emergency room (ER), where a computerised tomogram (CT) scan was ordered, and a blood clot (pulmonary embolism) in the lungs was confirmed. The patient did not confirm any hospital admission. Still, the physician for Hizentra decided to hold her infusions for four weeks to monitor the patient and let the new medication, Eliquis (anticoagulant), settle in the system. The patient adds that on the brighter side, her IgG levels were in the ideal range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and did not feel good was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210738853-covid-19 vaccine ad26.cov2.s -pulmonary embolism. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lacrimation increased
Clinical narrative: Within an hour eye lids swoll upalmost completely shut; Around 30 minute mark vision becameblurred; eyes began tearing up; eyes are still swollen; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021(at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as not applicable. The patient had no known allergies. The concomitant medications were reported as  allergy injections (MANUFACTURER UNKNOWN) for unspecified indication within two weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Apr2021, 15 minutes after the vaccination there was zero side effects. Around 30 minutes at 11:00, the patient experienced blurred vision and eyes began tearing up. Within an hour eye lids had swollen up and almost completely shut. On an unknown date in Apr2021, the patient experienced swollen eyes. The adverse events did not result in a visit to the doctors or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with Benadryl after contacting the pharmacy. The clinical outcome of the events blurred vision, eyes tearing up and swollen eye lids was recovering, while that of swollen eyes was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lacrimation increased, Swelling of eyelid, Vision blurred
Clinical narrative: Within an hour eye lids swoll upalmost completely shut; Around 30 minute mark vision becameblurred; eyes began tearing up; eyes are still swollen; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021(at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as not applicable. The patient had no known allergies. The concomitant medications were reported as  allergy injections (MANUFACTURER UNKNOWN) for unspecified indication within two weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Apr2021, 15 minutes after the vaccination there was zero side effects. Around 30 minutes at 11:00, the patient experienced blurred vision and eyes began tearing up. Within an hour eye lids had swollen up and almost completely shut. On an unknown date in Apr2021, the patient experienced swollen eyes. The adverse events did not result in a visit to the doctors or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with Benadryl after contacting the pharmacy. The clinical outcome of the events blurred vision, eyes tearing up and swollen eye lids was recovering, while that of swollen eyes was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Guillain Barre; losing feeling in half of her body; feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck; Arm soreness; feeling achy/body aches; chills; 103.7 fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre) and HYPOAESTHESIA (losing feeling in half of her body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included EBV hepatitis in 2001. Concurrent medical conditions included Food allergy (Severe Anaphylaxis) since 05-Oct-1972, Allergy to antibiotic (Mild Anaphylaxis and Bad rash) since 04-Mar-2020, Allergy to antibiotic (Severe anaphyaxis) since 25-Aug-2020, Immune disorder (NOS) and Lyme disease since 1996.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA (losing feeling in half of her body) (seriousness criterion medically significant), PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches), CHILLS (chills) and PYREXIA (103.7 fever). On 16-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criterion medically significant). On 14-Apr-2021 at 1:00 PM, PYREXIA (103.7 fever) had resolved. On 01-Jun-2021, GUILLAIN-BARRE SYNDROME (Guillain Barre) had resolved with sequelae. At the time of the report, HYPOAESTHESIA (losing feeling in half of her body), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches) and CHILLS (chills) had resolved and PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 103.7 (High) 103.7 - fever.         Concomitant medication not provided by reporter. Treatment information not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow Up Appended-patient demography case was upgraded to serious with event (Guillain Barre); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Guillain Barre; losing feeling in half of her body; feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck; Arm soreness; feeling achy/body aches; chills; 103.7 fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre) and HYPOAESTHESIA (losing feeling in half of her body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included EBV hepatitis in 2001. Concurrent medical conditions included Food allergy (Severe Anaphylaxis) since 05-Oct-1972, Allergy to antibiotic (Mild Anaphylaxis and Bad rash) since 04-Mar-2020, Allergy to antibiotic (Severe anaphyaxis) since 25-Aug-2020, Immune disorder (NOS) and Lyme disease since 1996.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA (losing feeling in half of her body) (seriousness criterion medically significant), PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches), CHILLS (chills) and PYREXIA (103.7 fever). On 16-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criterion medically significant). On 14-Apr-2021 at 1:00 PM, PYREXIA (103.7 fever) had resolved. On 01-Jun-2021, GUILLAIN-BARRE SYNDROME (Guillain Barre) had resolved with sequelae. At the time of the report, HYPOAESTHESIA (losing feeling in half of her body), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches) and CHILLS (chills) had resolved and PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 103.7 (High) 103.7 - fever.         Concomitant medication not provided by reporter. Treatment information not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow Up Appended-patient demography case was upgraded to serious with event (Guillain Barre); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Guillain-Barre syndrome, Hypoaesthesia, Pain
Clinical narrative: Guillain Barre; losing feeling in half of her body; feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck; Arm soreness; feeling achy/body aches; chills; 103.7 fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre) and HYPOAESTHESIA (losing feeling in half of her body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included EBV hepatitis in 2001. Concurrent medical conditions included Food allergy (Severe Anaphylaxis) since 05-Oct-1972, Allergy to antibiotic (Mild Anaphylaxis and Bad rash) since 04-Mar-2020, Allergy to antibiotic (Severe anaphyaxis) since 25-Aug-2020, Immune disorder (NOS) and Lyme disease since 1996.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA (losing feeling in half of her body) (seriousness criterion medically significant), PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches), CHILLS (chills) and PYREXIA (103.7 fever). On 16-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criterion medically significant). On 14-Apr-2021 at 1:00 PM, PYREXIA (103.7 fever) had resolved. On 01-Jun-2021, GUILLAIN-BARRE SYNDROME (Guillain Barre) had resolved with sequelae. At the time of the report, HYPOAESTHESIA (losing feeling in half of her body), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches) and CHILLS (chills) had resolved and PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 103.7 (High) 103.7 - fever.         Concomitant medication not provided by reporter. Treatment information not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow Up Appended-patient demography case was upgraded to serious with event (Guillain Barre); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Guillain Barre; losing feeling in half of her body; feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck; Arm soreness; feeling achy/body aches; chills; 103.7 fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre) and HYPOAESTHESIA (losing feeling in half of her body) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included EBV hepatitis in 2001. Concurrent medical conditions included Food allergy (Severe Anaphylaxis) since 05-Oct-1972, Allergy to antibiotic (Mild Anaphylaxis and Bad rash) since 04-Mar-2020, Allergy to antibiotic (Severe anaphyaxis) since 25-Aug-2020, Immune disorder (NOS) and Lyme disease since 1996.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA (losing feeling in half of her body) (seriousness criterion medically significant), PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches), CHILLS (chills) and PYREXIA (103.7 fever). On 16-Apr-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criterion medically significant). On 14-Apr-2021 at 1:00 PM, PYREXIA (103.7 fever) had resolved. On 01-Jun-2021, GUILLAIN-BARRE SYNDROME (Guillain Barre) had resolved with sequelae. At the time of the report, HYPOAESTHESIA (losing feeling in half of her body), PAIN IN EXTREMITY (Arm soreness), PAIN (feeling achy/body aches) and CHILLS (chills) had resolved and PARAESTHESIA (feeling numbness and pins and needles of her arms, hands, legs, feet, face and neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 103.7 (High) 103.7 - fever.         Concomitant medication not provided by reporter. Treatment information not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow Up Appended-patient demography case was upgraded to serious with event (Guillain Barre); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood pressure increased, Blood pressure measurement, Discomfort
Clinical narrative: -In the first 10 min.       -Started getting a metal taste in my mouth       -Started felling heavy like someone was sitting on me               -Nurses checked my BP which was high        -Then I started shaking                -Nurses laid me down                          -Checked BP again which was then low                                     -Started having more severe convulsions                                                 -Nurses checked my pulse and it was weak, they called for an ambulance and gave me oxygen        -Ambulance arrived continued oxygen and gave me Versed        -Arrived at hospital and had an EKG done        -Left side was then weak and walking was difficult        -Was given fluids at the ER        -Was sent home at 9pm -Continued to have left side weakness and difficulty walking for the next month, started PT, and was told to get the 2nd vaccine despite the reaction.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Fatigue, Muscle spasms, Nausea, Neck pain
Clinical narrative: -In the first 10 min.       -Started getting a metal taste in my mouth       -Started felling heavy like someone was sitting on me               -Nurses checked my BP which was high        -Then I started shaking                -Nurses laid me down                          -Checked BP again which was then low                                     -Started having more severe convulsions                                                 -Nurses checked my pulse and it was weak, they called for an ambulance and gave me oxygen        -Ambulance arrived continued oxygen and gave me Versed        -Arrived at hospital and had an EKG done        -Left side was then weak and walking was difficult        -Was given fluids at the ER        -Was sent home at 9pm -Continued to have left side weakness and difficulty walking for the next month, started PT, and was told to get the 2nd vaccine despite the reaction.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Tremor, Vaccination site pain
Clinical narrative: -In the first 10 min.       -Started getting a metal taste in my mouth       -Started felling heavy like someone was sitting on me               -Nurses checked my BP which was high        -Then I started shaking                -Nurses laid me down                          -Checked BP again which was then low                                     -Started having more severe convulsions                                                 -Nurses checked my pulse and it was weak, they called for an ambulance and gave me oxygen        -Ambulance arrived continued oxygen and gave me Versed        -Arrived at hospital and had an EKG done        -Left side was then weak and walking was difficult        -Was given fluids at the ER        -Was sent home at 9pm -Continued to have left side weakness and difficulty walking for the next month, started PT, and was told to get the 2nd vaccine despite the reaction.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Discomfort, Dysgeusia, Electrocardiogram normal, Gait disturbance
Clinical narrative: -In the first 10 min.       -Started getting a metal taste in my mouth       -Started felling heavy like someone was sitting on me               -Nurses checked my BP which was high        -Then I started shaking                -Nurses laid me down                          -Checked BP again which was then low                                     -Started having more severe convulsions                                                 -Nurses checked my pulse and it was weak, they called for an ambulance and gave me oxygen        -Ambulance arrived continued oxygen and gave me Versed        -Arrived at hospital and had an EKG done        -Left side was then weak and walking was difficult        -Was given fluids at the ER        -Was sent home at 9pm -Continued to have left side weakness and difficulty walking for the next month, started PT, and was told to get the 2nd vaccine despite the reaction.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypertension, Hypotension, Pulse abnormal, Seizure
Clinical narrative: -In the first 10 min.       -Started getting a metal taste in my mouth       -Started felling heavy like someone was sitting on me               -Nurses checked my BP which was high        -Then I started shaking                -Nurses laid me down                          -Checked BP again which was then low                                     -Started having more severe convulsions                                                 -Nurses checked my pulse and it was weak, they called for an ambulance and gave me oxygen        -Ambulance arrived continued oxygen and gave me Versed        -Arrived at hospital and had an EKG done        -Left side was then weak and walking was difficult        -Was given fluids at the ER        -Was sent home at 9pm -Continued to have left side weakness and difficulty walking for the next month, started PT, and was told to get the 2nd vaccine despite the reaction.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: -In the first 10 min.       -Started getting a metal taste in my mouth       -Started felling heavy like someone was sitting on me               -Nurses checked my BP which was high        -Then I started shaking                -Nurses laid me down                          -Checked BP again which was then low                                     -Started having more severe convulsions                                                 -Nurses checked my pulse and it was weak, they called for an ambulance and gave me oxygen        -Ambulance arrived continued oxygen and gave me Versed        -Arrived at hospital and had an EKG done        -Left side was then weak and walking was difficult        -Was given fluids at the ER        -Was sent home at 9pm -Continued to have left side weakness and difficulty walking for the next month, started PT, and was told to get the 2nd vaccine despite the reaction.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, Swelling face
Clinical narrative: heart racing; started having a strange feeling in left cheek.  It felt like had a dental procedure requiring numbing. The area felt warm and immediately spread to left eye and lip. It then spread around left eyebrow and down to chin.; started having a strange feeling in left cheek.  It felt like had a dental procedure requiring numbing. The area felt warm and immediately spread to left eye and lip. It then spread around left eyebrow and down to chin.; high blood pressure; high pulse rate; This is a spontaneous report received from a contactable consumer (patient) via regulatory authority.   A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, right hemicolectomy for colon cancer in 2019. The patient had known allergy to paracetamol (TYLENOL), clarithromycin (BIAXIN), penicillin (MANUFACTURER UNKNOWN) and fluconazole (DIFLUCAN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications received within two weeks of vaccination included lisinopril 5mg (MANUFACTURER UNKNOWN) and unspecified multivitamins.  On 31Mar2021, at 10:00, the patient experienced heart racing.  It felt like had a dental procedure requiring numbing. The area felt warm and immediately spread to left eye and lip. It then spread around left eyebrow and down to chin, high blood pressure, high pulse rate. Details were as follows: On 31Mar2021 at 10:00, right after getting the shot, the patient walked to a chair in the 15-minute waiting area. As soon as she sat down her heart started racing. She raised her hand and several nurses came to aid her. By the time they walked across the room to get to her, she started having a strange feeling in her left cheek. They had laid her down, she felt like she had a dental procedure requiring numbing. The area felt warm and immediately spread to her left eye and lip. It then spread around her left eyebrow and down to her chin. EMS (Emergency Medical Service) on site monitored her high blood pressure, high pulse rate, and checked her heart. The event resulted in visit to emergency room/department or urgent care. On 31Mar2021, therapeutic measures were taken as a result of adverse events; the patient had CT (Computed Tomography) scan, EKG (Electrocardiogram) and bloodwork with unknown results. The clinical outcome of  all the events was resolved with sequelae in Apr2021.  No follow-up attempts are needed. No further information is expected.