chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Troponin normal
Clinical narrative: Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night.  Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved.  COVID was not tested post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Dyskinesia, Insomnia, Magnetic resonance imaging spinal
Clinical narrative: Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night.  Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved.  COVID was not tested post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle contractions involuntary, Muscle fatigue, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night.  Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved.  COVID was not tested post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myoclonus, Pain in extremity, Palpitations, Paraesthesia, Tic
Clinical narrative: Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night.  Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved.  COVID was not tested post vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Extreme muscle fatigue when walking; Weakness in left leg; Frequent muscle spasms; tremors; stabbing muscle pain; "pins and needles" all over body; chest tightness; heart palpitations; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk."; Sharp, stabbing pain in legs; Thousands of fasciculations in all parts of the body, except for the head; inability to sleep; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 10Apr2021 at 14:30, at patient age of 46-year-old, as single dose (Lot number EW0158) for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's medical history included vestibular migraines, hypothyroidism. The patient's known allergies included multiple environmental allergies, but nor drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included levothyroxine sodium (SYNTROID) for hypothyroidism, sertraline hydrochloride (ZOLOFT) for vestibular migraine. The patient experienced the adverse events from 11Apr2021 at 02:15 AM. Symptoms started 12 hours after vaccine, 2:15 at night with sharp, stabbing pain in legs. Thousands of fasciculations in all parts of the body, except for the head. During the day: extreme muscle fatigue when walking, weakness in left leg, frequent muscle spasms, tremors, stabbing muscle pain, "pins and needles" all over body, heart palpitations and chest tightness, tremors upon waking up. 7 weeks later, myoclonus started and facial tics and fasciculations - different parts of the body would randomly "jerk." Heart palpitations are still very strong, inability to sleep - being awaken by the muscle "jerks" numerous times per night.  Blood work and MRI of the spine are normal in Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Clonazepam (CLONOPIN) was prescribed with little effect. The outcome of the events was not resolved.  COVID was not tested post vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Electrocardiogram, Headache, Nausea
Clinical narrative: high blood pressure; nausea; severe headaches; severe night sweats; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number FW0151) via an unspecified route of administration on 16Apr2021 at 11:45 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included obesity without hypertension, arthritis, and psoriasis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination. Concomitant medications included "ibu," cinnamon, and beet root from unknown dates for unknown indications. The patient was not sure if she had any allergies. The patient previously received dose 1 of BNT162B2 (lot number ER8730) on 25Mar2021 at 11:45 as a single dose in the right arm for COVID-19 immunization. On 17Apr2021 at 12:00, the patient experienced severe headaches and continued. On 17Apr2021 PM the patient started severe night sweats and continued. On 18Apr2021, the patient experienced "nausea one time event." On 27Apr2021 in the afternoon the patient had high blood pressure. On 28Apr2021 she had severe high blood pressure, 198/98 at home. At the ER over 200. The patient visited the emergency room as a result of the events. The patient received treatment with blood pressure medications (BP meds) in ER and took home a prescription for continued BP "ME." The outcome of headaches was decreased but not completely gone. The outcome of nausea was recovered. The outcome of increased blood pressures and night sweats was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pain in extremity, Urine analysis
Clinical narrative: high blood pressure; nausea; severe headaches; severe night sweats; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number FW0151) via an unspecified route of administration on 16Apr2021 at 11:45 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included obesity without hypertension, arthritis, and psoriasis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination. Concomitant medications included "ibu," cinnamon, and beet root from unknown dates for unknown indications. The patient was not sure if she had any allergies. The patient previously received dose 1 of BNT162B2 (lot number ER8730) on 25Mar2021 at 11:45 as a single dose in the right arm for COVID-19 immunization. On 17Apr2021 at 12:00, the patient experienced severe headaches and continued. On 17Apr2021 PM the patient started severe night sweats and continued. On 18Apr2021, the patient experienced "nausea one time event." On 27Apr2021 in the afternoon the patient had high blood pressure. On 28Apr2021 she had severe high blood pressure, 198/98 at home. At the ER over 200. The patient visited the emergency room as a result of the events. The patient received treatment with blood pressure medications (BP meds) in ER and took home a prescription for continued BP "ME." The outcome of headaches was decreased but not completely gone. The outcome of nausea was recovered. The outcome of increased blood pressures and night sweats was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Nausea, Night sweats
Clinical narrative: high blood pressure; nausea; severe headaches; severe night sweats; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number FW0151) via an unspecified route of administration on 16Apr2021 at 11:45 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included obesity without hypertension, arthritis, and psoriasis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination. Concomitant medications included "ibu," cinnamon, and beet root from unknown dates for unknown indications. The patient was not sure if she had any allergies. The patient previously received dose 1 of BNT162B2 (lot number ER8730) on 25Mar2021 at 11:45 as a single dose in the right arm for COVID-19 immunization. On 17Apr2021 at 12:00, the patient experienced severe headaches and continued. On 17Apr2021 PM the patient started severe night sweats and continued. On 18Apr2021, the patient experienced "nausea one time event." On 27Apr2021 in the afternoon the patient had high blood pressure. On 28Apr2021 she had severe high blood pressure, 198/98 at home. At the ER over 200. The patient visited the emergency room as a result of the events. The patient received treatment with blood pressure medications (BP meds) in ER and took home a prescription for continued BP "ME." The outcome of headaches was decreased but not completely gone. The outcome of nausea was recovered. The outcome of increased blood pressures and night sweats was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parosmia
Clinical narrative: Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Chills, Diarrhoea, Dysarthria
Clinical narrative: Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Nausea, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan, Sneezing, Taste disorder, Thinking abnormal
Clinical narrative: Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pain in extremity, Pruritus, Rash
Clinical narrative: NEEDLE AND PIN SENSATION ON ENTIRE BODY; HOT BURNING; RASH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced needle and pin sensation on entire body, hot burning, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot burning, rash, and needle and pin sensation on entire body. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Paraesthesia, Rash
Clinical narrative: NEEDLE AND PIN SENSATION ON ENTIRE BODY; HOT BURNING; RASH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced needle and pin sensation on entire body, hot burning, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot burning, rash, and needle and pin sensation on entire body. This report was non-serious.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Dizziness
Clinical narrative: Advanced coronary artery disease, Arteriovascular risk factors, Chronic obstructive lung disease.COVID-19 2/10/2021, Recurrent GI bleed with iron deficiency
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiopathy, Chronic obstructive pulmonary disease, Coronary artery disease
Clinical narrative: Advanced coronary artery disease, Arteriovascular risk factors, Chronic obstructive lung disease.COVID-19 2/10/2021, Recurrent GI bleed with iron deficiency
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better.   (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Aphasia, Blindness, Chest X-ray normal, Chest discomfort
Clinical narrative: Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better.   (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram normal, Deafness, Disturbance in attention, Dizziness
Clinical narrative: Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better.   (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Hypoaesthesia, Hypotension, Loss of consciousness
Clinical narrative: Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better.   (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Syncope, Throat tightness, Vision blurred, Vomiting
Clinical narrative: Sat down to wait for 15 minutes like they usually ask after a new vaccine, thought I felt fine then next thing I know the pharmacist is waking me up telling me I went unconscious and I?m puking. I don?t remember where I am or what happened while this was happening, then my whole body goes numb and my vision goes extremely blurry and my chest is tight, then apparently I pass out again because I have EMTs waking me up after. My bp dropped extremely low, my chest and throat was tight, it was hard to breathe, my tongue felt weird, I was anxious, could hardly see for a while and it was hard to hear. I was so out of it for a while it was hard to talk. EMTs took me to the hospital. Was released that evening, but had continuing dizziness, body numbness, chest pain etc for several days before it got better.   (Doctor at ER said he couldn?t fully say if it was an allergic reaction because it?s so new he didn?t have that information, but the paperwork I have from the Walgreens RX lists Several of the events I experienced as allergic reactions)
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Catheter directed thrombolysis, Dyspnoea, Myocardial strain, Pulmonary embolism
Clinical narrative: Patient stated that she received her 2nd COVID vaccine on April 23rd and since then has had progressive shortness of breath with exertion. She said that the shortness of breath was so bad she had to come to ED for further evaluation.  Found to have pulmonary embolisms.  Treated with heparin drip at outside ER and then transitioned to enoxaparin 1 mg/kg BID.  On day 2 of admission, patient transferred to a tertiary center for possible catheter directed TPA/Thrombectomy due to her right heart strain and patient feeling dizzy when she moves.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Dizziness, Dyspnoea, Pulmonary embolism
Clinical narrative: Patient stated that she received her 2nd COVID vaccine on April 23rd and since then has had progressive shortness of breath with exertion. She said that the shortness of breath was so bad she had to come to ED for further evaluation.  Found to have pulmonary embolisms.  Treated with heparin drip at outside ER and then transitioned to enoxaparin 1 mg/kg BID.  On day 2 of admission, patient transferred to a tertiary center for possible catheter directed TPA/Thrombectomy due to her right heart strain and patient feeling dizzy when she moves.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Right ventricular dysfunction
Clinical narrative: Patient stated that she received her 2nd COVID vaccine on April 23rd and since then has had progressive shortness of breath with exertion. She said that the shortness of breath was so bad she had to come to ED for further evaluation.  Found to have pulmonary embolisms.  Treated with heparin drip at outside ER and then transitioned to enoxaparin 1 mg/kg BID.  On day 2 of admission, patient transferred to a tertiary center for possible catheter directed TPA/Thrombectomy due to her right heart strain and patient feeling dizzy when she moves.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister infected, Fatigue, Genital blister, Genital erythema, Genital herpes
Clinical narrative: I felt fatigue for about four weeks after second dose,; outbreak of Herpes ll; genital outbreak; blistering/itchy blistering on her finger; redness; itching/itchy blistering on her finger; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes II from 1991, reported as 30 years ago. The patient had no known allergies and prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included propranolol from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Mar2021 (at the age of 59-years-old) in the right arm for COVID-19 immunisation. The patient reported she felt fatigued for about four weeks after the second dose, especially when having to exert herself, "walking up a hill for example." The patient stated that she seemed better after four weeks and about one week later she got "what seemed to be" an outbreak of herpes II. She stated she had herpes thirty years ago with no additional outbreaks until now. She stated her symptoms where genital outbreak, some blistering, redness, itching and an itchy blistering on her finger. No treatment was received for the events. The clinical outcomes of fatigue for about four weeks after second dose, outbreak of herpes II, genital outbreak, blistering/itchy blistering on her finger, redness, itching/itchy blistering on her finger were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Genital swelling, Pruritus
Clinical narrative: I felt fatigue for about four weeks after second dose,; outbreak of Herpes ll; genital outbreak; blistering/itchy blistering on her finger; redness; itching/itchy blistering on her finger; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes II from 1991, reported as 30 years ago. The patient had no known allergies and prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included propranolol from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Mar2021 (at the age of 59-years-old) in the right arm for COVID-19 immunisation. The patient reported she felt fatigued for about four weeks after the second dose, especially when having to exert herself, "walking up a hill for example." The patient stated that she seemed better after four weeks and about one week later she got "what seemed to be" an outbreak of herpes II. She stated she had herpes thirty years ago with no additional outbreaks until now. She stated her symptoms where genital outbreak, some blistering, redness, itching and an itchy blistering on her finger. No treatment was received for the events. The clinical outcomes of fatigue for about four weeks after second dose, outbreak of herpes II, genital outbreak, blistering/itchy blistering on her finger, redness, itching/itchy blistering on her finger were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Fatigue, Genital herpes, Herpes simplex
Clinical narrative: I felt fatigue for about four weeks after second dose,; outbreak of Herpes ll; genital outbreak; blistering/itchy blistering on her finger; redness; itching/itchy blistering on her finger; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes II from 1991, reported as 30 years ago. The patient had no known allergies and prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included propranolol from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Mar2021 (at the age of 59-years-old) in the right arm for COVID-19 immunisation. The patient reported she felt fatigued for about four weeks after the second dose, especially when having to exert herself, "walking up a hill for example." The patient stated that she seemed better after four weeks and about one week later she got "what seemed to be" an outbreak of herpes II. She stated she had herpes thirty years ago with no additional outbreaks until now. She stated her symptoms where genital outbreak, some blistering, redness, itching and an itchy blistering on her finger. No treatment was received for the events. The clinical outcomes of fatigue for about four weeks after second dose, outbreak of herpes II, genital outbreak, blistering/itchy blistering on her finger, redness, itching/itchy blistering on her finger were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: I felt fatigue for about four weeks after second dose,; outbreak of Herpes ll; genital outbreak; blistering/itchy blistering on her finger; redness; itching/itchy blistering on her finger; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes II from 1991, reported as 30 years ago. The patient had no known allergies and prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in four weeks. Concomitant medications included propranolol from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Mar2021 (at the age of 59-years-old) in the right arm for COVID-19 immunisation. The patient reported she felt fatigued for about four weeks after the second dose, especially when having to exert herself, "walking up a hill for example." The patient stated that she seemed better after four weeks and about one week later she got "what seemed to be" an outbreak of herpes II. She stated she had herpes thirty years ago with no additional outbreaks until now. She stated her symptoms where genital outbreak, some blistering, redness, itching and an itchy blistering on her finger. No treatment was received for the events. The clinical outcomes of fatigue for about four weeks after second dose, outbreak of herpes II, genital outbreak, blistering/itchy blistering on her finger, redness, itching/itchy blistering on her finger were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram head, Dyspnoea, Echocardiogram
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Functional gastrointestinal disorder, Gastrointestinal disorder, Hypoaesthesia, Injection site pain
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Loss of control of legs, Magnetic resonance imaging head, Migraine, Mobility decreased
Clinical narrative: Guillain-Barre syndrome; Pericarditis; Fainted once; Thought i had a seizure; Chest pain that went away as fast as it came; Gastrointestinal symptoms; Nosebleed; Dizziness; arm hurts; Arm pain in injection arm; Extreme headache; Chills all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once) and SEIZURE (Thought i had a seizure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), SYNCOPE (Fainted once) (seriousness criterion medically significant), SEIZURE (Thought i had a seizure) (seriousness criterion medically significant), CHEST PAIN (Chest pain that went away as fast as it came), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), PERICARDITIS (Pericarditis), SYNCOPE (Fainted once), SEIZURE (Thought i had a seizure), GASTROINTESTINAL DISORDER (Gastrointestinal symptoms), EPISTAXIS (Nosebleed), DIZZINESS (Dizziness), PAIN IN EXTREMITY (arm hurts), VACCINATION SITE PAIN (Arm pain in injection arm), HEADACHE (Extreme headache) and CHILLS (Chills all over the body) outcome was unknown and CHEST PAIN (Chest pain that went away as fast as it came) had resolved.            Concomitant medication and treatment information were not reported.  It was reported that the patient went to the hospital three times. The patient can not walk now and has permanent issues  Action taken with mRNA-1273 in response to the event was Not Applicable  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.