chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Common side effects for 5 days following second dose: headache, muscle aches, joint pain, fever, chills.  Joint pain has continued ever since.  Developed aloepecia areata shortly after receiving second dose, dermatologist suggests it may be direct side effect of vaccine, permanence unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia areata, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Common side effects for 5 days following second dose: headache, muscle aches, joint pain, fever, chills.  Joint pain has continued ever since.  Developed aloepecia areata shortly after receiving second dose, dermatologist suggests it may be direct side effect of vaccine, permanence unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Common side effects for 5 days following second dose: headache, muscle aches, joint pain, fever, chills.  Joint pain has continued ever since.  Developed aloepecia areata shortly after receiving second dose, dermatologist suggests it may be direct side effect of vaccine, permanence unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Unevaluable event
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year old male. Initial information was processed along with additional information received on 03-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, alcohol use occasionally 2-3 drinks a week, gout, and hypercholesterolemia, and other pre-existing medical conditions included patient had no known allergies and was not allergic to any medication. patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: unknown) frequency 1 total, dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included allopurinol for gout, atorvastatin for hypercholesterolemia, magnesium, Tamsulosin, and vitamins nos. On 23-APR-2021, the patient experienced suspected immunological vaccine failure. Patient did not experience any side effects. Three weeks later (23-APR-2021) after the vaccination, patient decided to get the antibody test, they found no antibody and he did a regular blood test on 24-APR-2021 and still they did not find antibodies. On the day of vaccination, he did not take any Tylenol or Advil and he did not develop any side effects.  On 23-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative, and SARS-CoV-2 IgM antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210504060-Covid-19 vaccine ad26.cov2.s-suspected immunological vaccination failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 61 year old male. Initial information was processed along with additional information received on 03-MAY-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, alcohol use occasionally 2-3 drinks a week, gout, and hypercholesterolemia, and other pre-existing medical conditions included patient had no known allergies and was not allergic to any medication. patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: unknown) frequency 1 total, dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included allopurinol for gout, atorvastatin for hypercholesterolemia, magnesium, Tamsulosin, and vitamins nos. On 23-APR-2021, the patient experienced suspected immunological vaccine failure. Patient did not experience any side effects. Three weeks later (23-APR-2021) after the vaccination, patient decided to get the antibody test, they found no antibody and he did a regular blood test on 24-APR-2021 and still they did not find antibodies. On the day of vaccination, he did not take any Tylenol or Advil and he did not develop any side effects.  On 23-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative, and SARS-CoV-2 IgM antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210504060-Covid-19 vaccine ad26.cov2.s-suspected immunological vaccination failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest X-ray, Chest pain, Fibrin D dimer, Full blood count
Clinical narrative: sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung.  CT with radioactive dye ruled out Pulmonary Embolism. Swollen lymph nodes also noted in left armpit
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Liver function test, Musculoskeletal chest pain, Pleural effusion
Clinical narrative: sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung.  CT with radioactive dye ruled out Pulmonary Embolism. Swollen lymph nodes also noted in left armpit
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Computerised tomogram normal, Electrocardiogram
Clinical narrative: sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung.  CT with radioactive dye ruled out Pulmonary Embolism. Swollen lymph nodes also noted in left armpit
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pleural effusion
Clinical narrative: sharp pain left chest. chest x-ray revealed pulmonary effusion in left lung.  CT with radioactive dye ruled out Pulmonary Embolism. Swollen lymph nodes also noted in left armpit
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia, Immunology test, Platelet factor 4
Clinical narrative: PAIN; RASH; WEAKNESS; THROMBOCYTOPENIA; VEIN ENLARGEMENT; This spontaneous report received from a health care professional concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's past medical history included previous liver disease/unknown etiology, and concurrent conditions included poorly controlled diabetic, and hyperlipemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 13:20 for prophylactic vaccination. No concomitant medications were reported.  on 26-APR-2021, the patient came to hospital with complaint of rash and medical team noticed bruising in her legs and found she had thrombocytopenia. Additionally, the rash was noted along with vein enlargement and she had weakness. The patient was referred to intensive case unit (ICU) and hospitalized. On an unspecified date, the patient experienced pain. She was on Motrin and now  switched on Mobic for the treatment of pain. The patient was hospitalized from 4 days and still in critical care unit. Laboratory data included: Antinuclear antibody: Negative, COVID-19 virus test: Negative, Fibrin D dimer: 0.50 (range is <0.50 mg/L), Heparin-induced platelet antibody: Antiplatelet factor 4, Heparin-induced thrombocytopenia: negative, and Platelet factor 4: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombocytopenia, and the outcome of pain, rash, weakness and vein enlargement was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0- 20210456582-COVID-19 VACCINE AD26.CCOVID-19 VACCINE AD26.COV2.SOV2.S-Thrombocytopenia,Pain,Vein enlargement. This event(s) is considered  unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 - 20210456582-COVID-19 VACCINE AD26.COV2.S-rash,weakness. This event(s) is labelled per RSI and is therefore considered potentially related.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Asthenia, Fibrin D dimer, Heparin-induced thrombocytopenia, Heparin-induced thrombocytopenia test
Clinical narrative: PAIN; RASH; WEAKNESS; THROMBOCYTOPENIA; VEIN ENLARGEMENT; This spontaneous report received from a health care professional concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's past medical history included previous liver disease/unknown etiology, and concurrent conditions included poorly controlled diabetic, and hyperlipemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 13:20 for prophylactic vaccination. No concomitant medications were reported.  on 26-APR-2021, the patient came to hospital with complaint of rash and medical team noticed bruising in her legs and found she had thrombocytopenia. Additionally, the rash was noted along with vein enlargement and she had weakness. The patient was referred to intensive case unit (ICU) and hospitalized. On an unspecified date, the patient experienced pain. She was on Motrin and now  switched on Mobic for the treatment of pain. The patient was hospitalized from 4 days and still in critical care unit. Laboratory data included: Antinuclear antibody: Negative, COVID-19 virus test: Negative, Fibrin D dimer: 0.50 (range is <0.50 mg/L), Heparin-induced platelet antibody: Antiplatelet factor 4, Heparin-induced thrombocytopenia: negative, and Platelet factor 4: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombocytopenia, and the outcome of pain, rash, weakness and vein enlargement was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0- 20210456582-COVID-19 VACCINE AD26.CCOVID-19 VACCINE AD26.COV2.SOV2.S-Thrombocytopenia,Pain,Vein enlargement. This event(s) is considered  unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 - 20210456582-COVID-19 VACCINE AD26.COV2.S-rash,weakness. This event(s) is labelled per RSI and is therefore considered potentially related.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Platelet factor 4, Rash, SARS-CoV-2 test negative, Thrombocytopenia
Clinical narrative: PAIN; RASH; WEAKNESS; THROMBOCYTOPENIA; VEIN ENLARGEMENT; This spontaneous report received from a health care professional concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's past medical history included previous liver disease/unknown etiology, and concurrent conditions included poorly controlled diabetic, and hyperlipemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 13:20 for prophylactic vaccination. No concomitant medications were reported.  on 26-APR-2021, the patient came to hospital with complaint of rash and medical team noticed bruising in her legs and found she had thrombocytopenia. Additionally, the rash was noted along with vein enlargement and she had weakness. The patient was referred to intensive case unit (ICU) and hospitalized. On an unspecified date, the patient experienced pain. She was on Motrin and now  switched on Mobic for the treatment of pain. The patient was hospitalized from 4 days and still in critical care unit. Laboratory data included: Antinuclear antibody: Negative, COVID-19 virus test: Negative, Fibrin D dimer: 0.50 (range is <0.50 mg/L), Heparin-induced platelet antibody: Antiplatelet factor 4, Heparin-induced thrombocytopenia: negative, and Platelet factor 4: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombocytopenia, and the outcome of pain, rash, weakness and vein enlargement was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0- 20210456582-COVID-19 VACCINE AD26.CCOVID-19 VACCINE AD26.COV2.SOV2.S-Thrombocytopenia,Pain,Vein enlargement. This event(s) is considered  unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 - 20210456582-COVID-19 VACCINE AD26.COV2.S-rash,weakness. This event(s) is labelled per RSI and is therefore considered potentially related.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vasodilatation
Clinical narrative: PAIN; RASH; WEAKNESS; THROMBOCYTOPENIA; VEIN ENLARGEMENT; This spontaneous report received from a health care professional concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's past medical history included previous liver disease/unknown etiology, and concurrent conditions included poorly controlled diabetic, and hyperlipemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 13:20 for prophylactic vaccination. No concomitant medications were reported.  on 26-APR-2021, the patient came to hospital with complaint of rash and medical team noticed bruising in her legs and found she had thrombocytopenia. Additionally, the rash was noted along with vein enlargement and she had weakness. The patient was referred to intensive case unit (ICU) and hospitalized. On an unspecified date, the patient experienced pain. She was on Motrin and now  switched on Mobic for the treatment of pain. The patient was hospitalized from 4 days and still in critical care unit. Laboratory data included: Antinuclear antibody: Negative, COVID-19 virus test: Negative, Fibrin D dimer: 0.50 (range is <0.50 mg/L), Heparin-induced platelet antibody: Antiplatelet factor 4, Heparin-induced thrombocytopenia: negative, and Platelet factor 4: Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thrombocytopenia, and the outcome of pain, rash, weakness and vein enlargement was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: V0- 20210456582-COVID-19 VACCINE AD26.CCOVID-19 VACCINE AD26.COV2.SOV2.S-Thrombocytopenia,Pain,Vein enlargement. This event(s) is considered  unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 - 20210456582-COVID-19 VACCINE AD26.COV2.S-rash,weakness. This event(s) is labelled per RSI and is therefore considered potentially related.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Cardiac ventricular thrombosis, Catheterisation cardiac, Cerebellar stroke, Echocardiogram
Clinical narrative: This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care.   Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia.   Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath.   While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care.   Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia.   Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath.   While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Cardiac ventricular thrombosis, Catheterisation cardiac, Cerebrovascular accident, Chest pain
Clinical narrative: This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care.   Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia.   Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath.   While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Dyspnoea, Ejection fraction decreased, Fine motor skill dysfunction, Haematoma
Clinical narrative: This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care.   Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia.   Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath.   While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypokinesia, Magnetic resonance imaging head abnormal, Muscular weakness, Nausea, Neurological symptom
Clinical narrative: This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care.   Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia.   Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath.   While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: This is a 52 Y female with past medical history of GERD, seasonal allergy and maybe early onset of pre-diabetic (A1c of 5.7) who was transferred from the hospital for continuation of care.   Patient was initially presented to hospital on 4/25 for chest pain, shortness of breath and TIA symptoms and patient was transferred to after patient was found to have NSTEMI, LV thrombus and sub-acute stroke and r/o pneumonia.   Patient was in her usual state of health (was able to do elliptical machine with low resident for 14 mins without feeling any chest pain or shortness of breath) till 4/18 where patient received her 2nd Moderna shot. 1 day after the vaccine, patient developed N/V and then intermittent slurred speech, trouble spelling in her texts, L arm weakness was noted 4/23. + chest pain and shortness of breath.   While in hospital, MRI of the brain confirmed sub-acute stroke at R cerebrum, patient was noted to have trop of 20, echo showed EF of 25%, hypokinesis of mid-apical myocardium, large 3.8cm x 2.3cm mural apical thrombus. Patient underwent cardiac cath on 4/26, s/p PCI with DES on proximal LAD, post-cath small hematoma noted on R groin site.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Inappropriate schedule of product administration, Off label use
Clinical narrative: My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulseless.  Her medical history is non-contributory for a sudden cardiac death.  A full autopsy is pending.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Sudden death, Unresponsive to stimuli
Clinical narrative: My wife (age 47) died on 14Apr2021 of a sudden death. She was found at home unresponsive and pulseless.  Her medical history is non-contributory for a sudden cardiac death.  A full autopsy is pending.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: allergic reaction; tingling in his tongue; slight tingling on the left side of his face.; numbness in lips; tingling in his tongue and slight tingling on the left side of his face.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER2613) on 10Apr2021 10:00 AM at right deltoid (Right shoulder) at single dose for COVID-19 immunisation (to prevent COVID) in a church that had a partnership with (Facility name) in a breakroom area. Medical history included ongoing Barrett's esophagus and allergic to penicillin. No Prior Vaccinations (within 4 weeks). he states that he had a similar reaction to penicillin, and he let the people know that he was allergic to penicillin at the facility. NO Family Medical History Relevant to event. No Relevant Tests. Concomitant medication included pantoprazole from unspecified date in 2021 (He states he started taking it about 3 months ago) and ongoing for Barrett's esophagus. The patient stated he just reported an allergic reaction to the first dose of the vaccine that he took last Saturday. About an hour after he had an allergic reaction to it where he had tingling in his tongue and slight tingling on the left side of his face. He took Benadryl and it cleared up. However, the symptoms have not subsided and they have been persistent since last Saturday. He had been taking Benadryl since Saturday and then went to the Emergency Room on Wednesday and they put him on Zyrtec and a steroid. He asked if he should take the second dose. He then mentioned there are alternatives if you don't get the second dose where you wait a certain amount of time and can take a different vaccine. Patient further states that he received vaccine last Saturday, and about an hour after receiving the vaccine he was having tingling sensation in his tongue. He states that it was an allergic reaction. He says that he also had slight numbness in lips and on the side of his face. He states he took Benadryl (22May lot smf011). He states that the Benadryl helped him out for 4 hours. He states that the symptoms went away for 4 hours and then started reoccurring. He states that it was happening like that, that cycle, since last Saturday. He states that he went to the hospital on Wednesday and they prescribed him a steroid which he has been taking for a 4 day cycle. He states that he just ran out of the steroid yesterday. He states that the steroid was Prednisone, and he takes 20 mg, two tablets by mouth daily. Caller states that the numbness is progressive. He states that if he doesn't take the medicine on time then it progresses. He states as long as he is taking his medication on time than the symptoms are mild. events require a visit Emergency Room and Physician Office. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: allergic reaction; tingling in his tongue; slight tingling on the left side of his face.; numbness in lips; tingling in his tongue and slight tingling on the left side of his face.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER2613) on 10Apr2021 10:00 AM at right deltoid (Right shoulder) at single dose for COVID-19 immunisation (to prevent COVID) in a church that had a partnership with (Facility name) in a breakroom area. Medical history included ongoing Barrett's esophagus and allergic to penicillin. No Prior Vaccinations (within 4 weeks). he states that he had a similar reaction to penicillin, and he let the people know that he was allergic to penicillin at the facility. NO Family Medical History Relevant to event. No Relevant Tests. Concomitant medication included pantoprazole from unspecified date in 2021 (He states he started taking it about 3 months ago) and ongoing for Barrett's esophagus. The patient stated he just reported an allergic reaction to the first dose of the vaccine that he took last Saturday. About an hour after he had an allergic reaction to it where he had tingling in his tongue and slight tingling on the left side of his face. He took Benadryl and it cleared up. However, the symptoms have not subsided and they have been persistent since last Saturday. He had been taking Benadryl since Saturday and then went to the Emergency Room on Wednesday and they put him on Zyrtec and a steroid. He asked if he should take the second dose. He then mentioned there are alternatives if you don't get the second dose where you wait a certain amount of time and can take a different vaccine. Patient further states that he received vaccine last Saturday, and about an hour after receiving the vaccine he was having tingling sensation in his tongue. He states that it was an allergic reaction. He says that he also had slight numbness in lips and on the side of his face. He states he took Benadryl (22May lot smf011). He states that the Benadryl helped him out for 4 hours. He states that the symptoms went away for 4 hours and then started reoccurring. He states that it was happening like that, that cycle, since last Saturday. He states that he went to the hospital on Wednesday and they prescribed him a steroid which he has been taking for a 4 day cycle. He states that he just ran out of the steroid yesterday. He states that the steroid was Prednisone, and he takes 20 mg, two tablets by mouth daily. Caller states that the numbness is progressive. He states that if he doesn't take the medicine on time then it progresses. He states as long as he is taking his medication on time than the symptoms are mild. events require a visit Emergency Room and Physician Office. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Limb discomfort, Pain in extremity, Ultrasound Doppler
Clinical narrative: DEEP VEIN THROMBOSIS IN LEGS; This spontaneous report received from a patient concerned a female patient of unspecified age.   The patient's height, and weight were not reported. The patient's concomitant medical conditions included non smoker.  The patient is a Zumba teacher. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041821A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, reported as several days after vaccination, the patient felt some discomfort in the leg. The patient took Tylenol and rested for two weeks, however it did not improve. The patient went to the doctor for a follow up and physical and the doctor ordered a doppler, which showed blood clots in both legs. The doctor immediately placed the patient on Eliquis 5mg.  Patient reported that she needs to see a cardiologist and hematologist because she now has a DVT (deep vein thrombosis).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the DVT was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210505469-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: DEEP VEIN THROMBOSIS IN LEGS; This spontaneous report received from a patient concerned a female patient of unspecified age.   The patient's height, and weight were not reported. The patient's concomitant medical conditions included non smoker.  The patient is a Zumba teacher. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041821A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, reported as several days after vaccination, the patient felt some discomfort in the leg. The patient took Tylenol and rested for two weeks, however it did not improve. The patient went to the doctor for a follow up and physical and the doctor ordered a doppler, which showed blood clots in both legs. The doctor immediately placed the patient on Eliquis 5mg.  Patient reported that she needs to see a cardiologist and hematologist because she now has a DVT (deep vein thrombosis).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the DVT was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210505469-Covid-19 vaccine ad26.cov2.s-Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler
Clinical narrative: BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Feeling abnormal, Joint swelling, Muscle spasms, Pain
Clinical narrative: BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Thrombosis, Ultrasound Doppler
Clinical narrative: BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Muscle spasms, Swelling, Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT LEG; DIFFICULTY SLEEPING; SOME LEG CRAMPS; SWELLING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, 1 total on an unknown date in APR-2021 (reported as about three weeks ago from the date of reporting) on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Since an unknown date in APR-2021 (reported as about a week ago), the patient experienced swelling and some leg cramps. It was reported that nothing (swelling and leg cramps) was dramatic initially, however, they worsened. On 28-APR-2021 (reported as last night), the patient had difficulty in sleeping. On 29-APR-2021, the patient was diagnosed with blood clot in left leg by his doctor. At the time of report (reported as currently), the patient was in transport to a hospital for further evaluation. The patient further mentioned that he did not have possession of the vaccination card, but his wife had it and she would be arriving at hospital later. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg, swelling, and some leg cramps, and the outcome of difficulty sleeping was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Blood Clot in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Anticoagulant therapy, Cavernous sinus thrombosis, Headache, Magnetic resonance imaging head abnormal
Clinical narrative: Cerebral venous thrombosis on 4/29/2021. Note this had likely occurred prior. I had a headache off and on throughout April but it was never severe until the week of April 26.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Superior sagittal sinus thrombosis, Venogram normal
Clinical narrative: Cerebral venous thrombosis on 4/29/2021. Note this had likely occurred prior. I had a headache off and on throughout April but it was never severe until the week of April 26.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous thrombosis, Computerised tomogram head abnormal, Headache, Magnetic resonance imaging head abnormal
Clinical narrative: Cerebral venous thrombosis on 4/29/2021. Note this had likely occurred prior. I had a headache off and on throughout April but it was never severe until the week of April 26.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin reaction, Skin warm, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Patient had Johnson & Johnson vacccine and  18 days later had  red right calf and was diagnosed in ED with partial thrombus DVT right leg,  peroneal vein with no proximal ascension. She is taking Xarelto now.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Erythema, Ultrasound Doppler abnormal
Clinical narrative: Patient had Johnson & Johnson vacccine and  18 days later had  red right calf and was diagnosed in ED with partial thrombus DVT right leg,  peroneal vein with no proximal ascension. She is taking Xarelto now.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: The patient presented to the clinic to receive his 2nd Pfizer vaccine. I incorrectly ordered a Moderna for his 2nd immunization and  it was administered to the patient.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: The patient presented to the clinic to receive his 2nd Pfizer vaccine. I incorrectly ordered a Moderna for his 2nd immunization and  it was administered to the patient.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: MEDICATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a 39 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced incorrect storage of drug. On an unspecified date, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of drug and medication error was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: MEDICATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a 39 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-APR-2021, the subject experienced incorrect storage of drug. On an unspecified date, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of drug and medication error was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Pfizer Vaccine ordered, patient received Moderna vaccination,  patient tolerated the procedure well, patient was discharged after 20 minutes of waiting at stable condition.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer Vaccine ordered, patient received Moderna vaccination,  patient tolerated the procedure well, patient was discharged after 20 minutes of waiting at stable condition.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer vaccine ordered. Moderna vaccine administered. Patient tolerated the procedure well. Patient was discharged after 20 minutes of waiting at stable condition.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Muscle fatigue, Myalgia
Clinical narrative: muscle pain; fatigue; collarbone area pain; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included mass. Patient had a biopsy done due to a prior mass and result came back ok. The patient's concomitant medications were not reported. From 12Feb2021, patient experienced muscle pain and fatigue. On 13Feb2021, everything went away except the collarbone area pain. She stated its kept going worse. She was following up with the ENT doctor and he wanted to prescribe her steroids. Patient wanted to know information about it and what she could do about it. Outcome of events muscle pain and fatigue was resolved, and of event collarbone area pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.