chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysmenorrhoea, Headache, Heavy menstrual bleeding, Pain
Clinical narrative: 30yo female has been on combination oral contraceptive for 15 years, no PMH, no person/family hx of VTE. 2 weeks prior received Johnson & Johnson COVID vaccine, 2 days later develops bilateral calf pain which progressed until 3 days prior to Emergency Dept arrival when PCP ordered ultrasound, showed non-occlusive DVT in the left common femoral vein and no right leg DVT. Non-smoker. D-dimer 0.32  ug/mIFEU, platelets normal at 269k. Treated by starting apixaban and stopping combination oral contraceptive, discharged home from Emergency Dept with follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Thrombosis, Ultrasound scan vagina
Clinical narrative: 30yo female has been on combination oral contraceptive for 15 years, no PMH, no person/family hx of VTE. 2 weeks prior received Johnson & Johnson COVID vaccine, 2 days later develops bilateral calf pain which progressed until 3 days prior to Emergency Dept arrival when PCP ordered ultrasound, showed non-occlusive DVT in the left common femoral vein and no right leg DVT. Non-smoker. D-dimer 0.32  ug/mIFEU, platelets normal at 269k. Treated by starting apixaban and stopping combination oral contraceptive, discharged home from Emergency Dept with follow-up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Fibrin D dimer, Pain in extremity, Platelet count normal, Ultrasound scan abnormal
Clinical narrative: 30yo female has been on combination oral contraceptive for 15 years, no PMH, no person/family hx of VTE. 2 weeks prior received Johnson & Johnson COVID vaccine, 2 days later develops bilateral calf pain which progressed until 3 days prior to Emergency Dept arrival when PCP ordered ultrasound, showed non-occlusive DVT in the left common femoral vein and no right leg DVT. Non-smoker. D-dimer 0.32  ug/mIFEU, platelets normal at 269k. Treated by starting apixaban and stopping combination oral contraceptive, discharged home from Emergency Dept with follow-up.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Laboratory test, Renal embolism
Clinical narrative: Blood clots in both kidneys.  Hospitalized for seven 7 days with series of tests.  High blood pressure, high temperature, kidney infection.   No cause found - but J&J COVID vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram head normal, Hypertension, Investigation, Kidney infection
Clinical narrative: Blood clots in both kidneys.  Hospitalized for seven 7 days with series of tests.  High blood pressure, high temperature, kidney infection.   No cause found - but J&J COVID vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Renal vein thrombosis
Clinical narrative: Blood clots in both kidneys.  Hospitalized for seven 7 days with series of tests.  High blood pressure, high temperature, kidney infection.   No cause found - but J&J COVID vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram abnormal, Pulmonary embolism
Clinical narrative: Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: FN6206), via an unspecified route of administration in the right arm, on 16Mar2021 at 14:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pulmonary embolism on 30Mar2021 at 00:00 (reported as: 12:00 AM), which caused hospitalization. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 30Mar2021. Therapeutic measures were taken as a result of the event, which included apixaban (ELIQUIS). The clinical outcome of pulmonary embolism was recovering.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: FN6206), via an unspecified route of administration in the right arm, on 16Mar2021 at 14:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pulmonary embolism on 30Mar2021 at 00:00 (reported as: 12:00 AM), which caused hospitalization. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative on 30Mar2021. Therapeutic measures were taken as a result of the event, which included apixaban (ELIQUIS). The clinical outcome of pulmonary embolism was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: I was diagnosed with a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 03Mar2021 15:45 (Lot Number: EN6202), at the age of 49-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included none. The patient is not pregnant at the time of vaccination. The patient received dose 1 of the vaccine on 10Feb2021, lot number: EM9810, on 10Feb2021 03:45 PM at right arm. The patient did not have COVID-19 prior vaccination.  The patient's concomitant medications were not reported.  On 04Mar2021 12:00 AM, patient  was diagnosed with a blood clot in her right leg. The event required emergency room visit. The patient was put on Xarelto, a blood thinner for clots. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Electric shock sensation, Electrocardiogram, Feeling hot
Clinical narrative: NUMBNESS ON RIGHT SIDE INCLUDING FACE; RECURRENT FEELING OF ELECTRIC SHOCK; RECURRENT EPISODES OF ARRHYTHMIA; RECURRENT FEELING OF WAVE OF WARM LIQUID COME OVER WHOLE BODY; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021,15 minutes post-vaccination the patient experienced warm liquid feeling over whole body and happened 3 more times on same day. On 25-MAR-2021, the patient experienced electric shock feeling and arrhythmia twice on a same day. It was reported that, the patient experienced electric shock feeling and arrhythmia again on 26-MAR-2021, 27-MAR- 2021 and 30-MAR-2021 then patient was taken to hospital. She continued having symptoms and went back to emergency room with an Magnetic resonance imaging (MRI) on 13-APR-2021. She was now having numbness on right side including her face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on right side including face, and the outcome of warm liquid feeling over whole body, electric shock feeling and arrhythmia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: : 20210438273-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia 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: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging, Ocular discomfort, Paraesthesia
Clinical narrative: NUMBNESS ON RIGHT SIDE INCLUDING FACE; RECURRENT FEELING OF ELECTRIC SHOCK; RECURRENT EPISODES OF ARRHYTHMIA; RECURRENT FEELING OF WAVE OF WARM LIQUID COME OVER WHOLE BODY; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021,15 minutes post-vaccination the patient experienced warm liquid feeling over whole body and happened 3 more times on same day. On 25-MAR-2021, the patient experienced electric shock feeling and arrhythmia twice on a same day. It was reported that, the patient experienced electric shock feeling and arrhythmia again on 26-MAR-2021, 27-MAR- 2021 and 30-MAR-2021 then patient was taken to hospital. She continued having symptoms and went back to emergency room with an Magnetic resonance imaging (MRI) on 13-APR-2021. She was now having numbness on right side including her face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on right side including face, and the outcome of warm liquid feeling over whole body, electric shock feeling and arrhythmia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: : 20210438273-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia 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: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles, Visual impairment
Clinical narrative: NUMBNESS ON RIGHT SIDE INCLUDING FACE; RECURRENT FEELING OF ELECTRIC SHOCK; RECURRENT EPISODES OF ARRHYTHMIA; RECURRENT FEELING OF WAVE OF WARM LIQUID COME OVER WHOLE BODY; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021,15 minutes post-vaccination the patient experienced warm liquid feeling over whole body and happened 3 more times on same day. On 25-MAR-2021, the patient experienced electric shock feeling and arrhythmia twice on a same day. It was reported that, the patient experienced electric shock feeling and arrhythmia again on 26-MAR-2021, 27-MAR- 2021 and 30-MAR-2021 then patient was taken to hospital. She continued having symptoms and went back to emergency room with an Magnetic resonance imaging (MRI) on 13-APR-2021. She was now having numbness on right side including her face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on right side including face, and the outcome of warm liquid feeling over whole body, electric shock feeling and arrhythmia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: : 20210438273-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia 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: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Electric shock sensation, Feeling hot, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: NUMBNESS ON RIGHT SIDE INCLUDING FACE; RECURRENT FEELING OF ELECTRIC SHOCK; RECURRENT EPISODES OF ARRHYTHMIA; RECURRENT FEELING OF WAVE OF WARM LIQUID COME OVER WHOLE BODY; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021,15 minutes post-vaccination the patient experienced warm liquid feeling over whole body and happened 3 more times on same day. On 25-MAR-2021, the patient experienced electric shock feeling and arrhythmia twice on a same day. It was reported that, the patient experienced electric shock feeling and arrhythmia again on 26-MAR-2021, 27-MAR- 2021 and 30-MAR-2021 then patient was taken to hospital. She continued having symptoms and went back to emergency room with an Magnetic resonance imaging (MRI) on 13-APR-2021. She was now having numbness on right side including her face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on right side including face, and the outcome of warm liquid feeling over whole body, electric shock feeling and arrhythmia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: : 20210438273-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Arrhythmia 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest X-ray, Eye haemorrhage
Clinical narrative: RUPTURED BLOOD VESSEL IN  EYE; BLOOD PRESSURE HIGH; This spontaneous report received from a patient via a company representative concerned a 52 year old female. 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 was not reported, 1 total administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced an increased blood pressure (185/90) and a ruptured blood vessel in one of the eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure high, and ruptured blood vessel in eye on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210427953-Covid-19 vaccine ad26.cov2.s-Ruptured blood vessel in eye. This events is considered unassessable. The events 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 events.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Eye haemorrhage, Hypertension
Clinical narrative: RUPTURED BLOOD VESSEL IN  EYE; BLOOD PRESSURE HIGH; This spontaneous report received from a patient via a company representative concerned a 52 year old female. 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 was not reported, 1 total administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 29-MAR-2021, the patient experienced an increased blood pressure (185/90) and a ruptured blood vessel in one of the eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure high, and ruptured blood vessel in eye on 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210427953-Covid-19 vaccine ad26.cov2.s-Ruptured blood vessel in eye. This events is considered unassessable. The events 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 events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood count, Cerebral infarction, Cerebrovascular accident, Computerised tomogram, Echocardiogram
Clinical narrative: STROKE; LOSS OF SENSATION IN RIGHT LEG, LOSS OF SENSATION IN RIGHT ARM; This spontaneous report received from a parent concerned female of unspecified age. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the patient experienced loss of sensation in right leg, loss of sensation in right arm, and suffered a stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of sensation in right leg, loss of sensation in right arm and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210424592-covid-19 vaccine ad26.cov2. s- stroke, loss of sensation in right arm and right leg... This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Hypoaesthesia, Impaired work ability, Magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: STROKE; LOSS OF SENSATION IN RIGHT LEG, LOSS OF SENSATION IN RIGHT ARM; This spontaneous report received from a parent concerned female of unspecified age. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the patient experienced loss of sensation in right leg, loss of sensation in right arm, and suffered a stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of sensation in right leg, loss of sensation in right arm and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210424592-covid-19 vaccine ad26.cov2. s- stroke, loss of sensation in right arm and right leg... This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Sensory loss
Clinical narrative: STROKE; LOSS OF SENSATION IN RIGHT LEG, LOSS OF SENSATION IN RIGHT ARM; This spontaneous report received from a parent concerned female of unspecified age. 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the patient experienced loss of sensation in right leg, loss of sensation in right arm, and suffered a stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of sensation in right leg, loss of sensation in right arm and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210424592-covid-19 vaccine ad26.cov2. s- stroke, loss of sensation in right arm and right leg... This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash, Rash pruritic, Urticaria
Clinical narrative: Generalized rash noted 3 days after vaccination per patient. Denies any other s/s.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Generalized rash noted 3 days after vaccination per patient. Denies any other s/s.
Age: 72.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Lip swelling, Swelling face
Clinical narrative: Difficulty breathing; shortness of breath; swollen lips, tongue, eyes or face.
Age: 72.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Difficulty breathing; shortness of breath; swollen lips, tongue, eyes or face.
Age: 72.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Eye swelling, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Difficulty breathing; shortness of breath; swollen lips, tongue, eyes or face.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Decreased appetite, Feeling abnormal, Nausea, Pain of skin
Clinical narrative: joint pain; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest/painful sensation / it hurts when he touches it; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; parts of his left side have a rash / small rashes on head, shoulder, neck and chest; 3 quarter size areas on his left shoulder that look like poison oak or acne; 3 quarter size areas on his left shoulder that look like poison oak or acne; sore throat; is tired/ Fatigue; does not fell 100percent; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 7th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th April 2021, less than a day after receiving Shingrix, the patient experienced joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell. On 11th April 2021, the outcome of the joint pain was recovered/resolved. On an unknown date, the outcome of the stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient completed Covid vaccine series 2 months ago from the date of reporting. The patient received Shingrix in left arm. After receiving Shingrix, the patient had joint pain that went away.  He returned to the doctor however because he had and till the time of reporting, still had a stinging, burning painful sensation on left side.  Some parts of his left side have a rash, and some had no rash, but it hurt when he touched it.  The patient had small rashes on head, shoulder, neck and chest.  He had 3 quarter size areas on his left shoulder that looked like poison oak or acne.  The patient also had a sore throat that had not gone away.   The patient was tired and did not feel 100 percent. The doctor referred him to an allergist. The patient yet to follow up with allergist. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin burning sensation
Clinical narrative: joint pain; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest/painful sensation / it hurts when he touches it; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; parts of his left side have a rash / small rashes on head, shoulder, neck and chest; 3 quarter size areas on his left shoulder that look like poison oak or acne; 3 quarter size areas on his left shoulder that look like poison oak or acne; sore throat; is tired/ Fatigue; does not fell 100percent; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 7th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th April 2021, less than a day after receiving Shingrix, the patient experienced joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell. On 11th April 2021, the outcome of the joint pain was recovered/resolved. On an unknown date, the outcome of the stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient completed Covid vaccine series 2 months ago from the date of reporting. The patient received Shingrix in left arm. After receiving Shingrix, the patient had joint pain that went away.  He returned to the doctor however because he had and till the time of reporting, still had a stinging, burning painful sensation on left side.  Some parts of his left side have a rash, and some had no rash, but it hurt when he touched it.  The patient had small rashes on head, shoulder, neck and chest.  He had 3 quarter size areas on his left shoulder that looked like poison oak or acne.  The patient also had a sore throat that had not gone away.   The patient was tired and did not feel 100 percent. The doctor referred him to an allergist. The patient yet to follow up with allergist. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Arthralgia, Burning sensation, Chest pain, Dermatitis contact
Clinical narrative: joint pain; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest/painful sensation / it hurts when he touches it; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; parts of his left side have a rash / small rashes on head, shoulder, neck and chest; 3 quarter size areas on his left shoulder that look like poison oak or acne; 3 quarter size areas on his left shoulder that look like poison oak or acne; sore throat; is tired/ Fatigue; does not fell 100percent; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 7th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th April 2021, less than a day after receiving Shingrix, the patient experienced joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell. On 11th April 2021, the outcome of the joint pain was recovered/resolved. On an unknown date, the outcome of the stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient completed Covid vaccine series 2 months ago from the date of reporting. The patient received Shingrix in left arm. After receiving Shingrix, the patient had joint pain that went away.  He returned to the doctor however because he had and till the time of reporting, still had a stinging, burning painful sensation on left side.  Some parts of his left side have a rash, and some had no rash, but it hurt when he touched it.  The patient had small rashes on head, shoulder, neck and chest.  He had 3 quarter size areas on his left shoulder that looked like poison oak or acne.  The patient also had a sore throat that had not gone away.   The patient was tired and did not feel 100 percent. The doctor referred him to an allergist. The patient yet to follow up with allergist. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Malaise, Oropharyngeal pain, Pain, Rash
Clinical narrative: joint pain; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest/painful sensation / it hurts when he touches it; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; stinging, burning painful sensation on left side/ on head, neck, shoulders and chest; parts of his left side have a rash / small rashes on head, shoulder, neck and chest; 3 quarter size areas on his left shoulder that look like poison oak or acne; 3 quarter size areas on his left shoulder that look like poison oak or acne; sore throat; is tired/ Fatigue; does not fell 100percent; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 7th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th April 2021, less than a day after receiving Shingrix, the patient experienced joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell. On 11th April 2021, the outcome of the joint pain was recovered/resolved. On an unknown date, the outcome of the stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, stinging, burning sensation, chest burning, painful rash, poison oak rash, acne, sore throat, fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient completed Covid vaccine series 2 months ago from the date of reporting. The patient received Shingrix in left arm. After receiving Shingrix, the patient had joint pain that went away.  He returned to the doctor however because he had and till the time of reporting, still had a stinging, burning painful sensation on left side.  Some parts of his left side have a rash, and some had no rash, but it hurt when he touched it.  The patient had small rashes on head, shoulder, neck and chest.  He had 3 quarter size areas on his left shoulder that looked like poison oak or acne.  The patient also had a sore throat that had not gone away.   The patient was tired and did not feel 100 percent. The doctor referred him to an allergist. The patient yet to follow up with allergist. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient had dizziness. Did not eat or drink water since breakfast before 9AM. Waited in line over 2 hours. Gave 2 8-oz bottles of water. Stable, released from vaccination site.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Patient had dizziness. Did not eat or drink water since breakfast before 9AM. Waited in line over 2 hours. Gave 2 8-oz bottles of water. Stable, released from vaccination site.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Hypoaesthesia, Lip swelling, Paraesthesia
Clinical narrative: On April 5th, patient received the J&J covid vaccine from her PCP and admits to perioral itching approximately 10-15 minutes after receiving the vaccine. She believed her symptoms were secondary to eczema and went home after getting the vaccine. When she arrived home, she had developed both lip and tongue swelling. She called her primary care doctor and was recommended to take Benadryl 25mg and head to the ER. She felt very tired and instead of going to the ER she fell asleep. The next morning, she continued to experience perioral itching, lip swelling, and tongue swelling and went to a local emergency room where she was treated with IM epinephrine and discharged on pepsid/prednisone/benadryl. She noted improvement in her symptoms at this point and continued on Prednisone 40mg. However, one day later, she noticed the lip swelling and tongue swelling return and developed shortness of breath. She returned to the ER and was given IM epinephrine which helped her symptoms significantly. She was continued on Pepcid/Prednisone/Benadryl and discharged from the ER. Ultimately this continued for the last two weeks and last Friday, she was hospitalized at from April 16 to April 19. She was given racemic epinephrine and felt that was the most helpful in terms of alleviating her shortness of breath. While at hospital, she was started on Singulair, Zyrtec, Pepcid, and Benadryl.  She was evaluated by an Allergist on 4/19/21 and underwent an autoimmune workup (ANA, RF, ESR, CRP) and angioedema workup (C3, C4, C1INH, tryptase) which was reported as being unremarkable. She was also given a shot of Xolair however she has not noticed any improvement in her symptoms.  She came to the hospital yesterday due to continued symptoms and return of shortness of breath. She additionally began experiencing headaches and double vision consistent with her migraines but definitely worse than her past headaches. She was admitted to the the ICU and evaluated by ENT with laryngoscopy (unremarkable). She was started on Methylprednisolone with racemic epinephrine. She has been started on treatment with Firazyr (icatibant) 30mg which has helped with tongue swelling.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: On April 5th, patient received the J&J covid vaccine from her PCP and admits to perioral itching approximately 10-15 minutes after receiving the vaccine. She believed her symptoms were secondary to eczema and went home after getting the vaccine. When she arrived home, she had developed both lip and tongue swelling. She called her primary care doctor and was recommended to take Benadryl 25mg and head to the ER. She felt very tired and instead of going to the ER she fell asleep. The next morning, she continued to experience perioral itching, lip swelling, and tongue swelling and went to a local emergency room where she was treated with IM epinephrine and discharged on pepsid/prednisone/benadryl. She noted improvement in her symptoms at this point and continued on Prednisone 40mg. However, one day later, she noticed the lip swelling and tongue swelling return and developed shortness of breath. She returned to the ER and was given IM epinephrine which helped her symptoms significantly. She was continued on Pepcid/Prednisone/Benadryl and discharged from the ER. Ultimately this continued for the last two weeks and last Friday, she was hospitalized at from April 16 to April 19. She was given racemic epinephrine and felt that was the most helpful in terms of alleviating her shortness of breath. While at hospital, she was started on Singulair, Zyrtec, Pepcid, and Benadryl.  She was evaluated by an Allergist on 4/19/21 and underwent an autoimmune workup (ANA, RF, ESR, CRP) and angioedema workup (C3, C4, C1INH, tryptase) which was reported as being unremarkable. She was also given a shot of Xolair however she has not noticed any improvement in her symptoms.  She came to the hospital yesterday due to continued symptoms and return of shortness of breath. She additionally began experiencing headaches and double vision consistent with her migraines but definitely worse than her past headaches. She was admitted to the the ICU and evaluated by ENT with laryngoscopy (unremarkable). She was started on Methylprednisolone with racemic epinephrine. She has been started on treatment with Firazyr (icatibant) 30mg which has helped with tongue swelling.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein normal, C1 esterase inhibitor test normal, Complement factor C3, Complement factor C4
Clinical narrative: On April 5th, patient received the J&J covid vaccine from her PCP and admits to perioral itching approximately 10-15 minutes after receiving the vaccine. She believed her symptoms were secondary to eczema and went home after getting the vaccine. When she arrived home, she had developed both lip and tongue swelling. She called her primary care doctor and was recommended to take Benadryl 25mg and head to the ER. She felt very tired and instead of going to the ER she fell asleep. The next morning, she continued to experience perioral itching, lip swelling, and tongue swelling and went to a local emergency room where she was treated with IM epinephrine and discharged on pepsid/prednisone/benadryl. She noted improvement in her symptoms at this point and continued on Prednisone 40mg. However, one day later, she noticed the lip swelling and tongue swelling return and developed shortness of breath. She returned to the ER and was given IM epinephrine which helped her symptoms significantly. She was continued on Pepcid/Prednisone/Benadryl and discharged from the ER. Ultimately this continued for the last two weeks and last Friday, she was hospitalized at from April 16 to April 19. She was given racemic epinephrine and felt that was the most helpful in terms of alleviating her shortness of breath. While at hospital, she was started on Singulair, Zyrtec, Pepcid, and Benadryl.  She was evaluated by an Allergist on 4/19/21 and underwent an autoimmune workup (ANA, RF, ESR, CRP) and angioedema workup (C3, C4, C1INH, tryptase) which was reported as being unremarkable. She was also given a shot of Xolair however she has not noticed any improvement in her symptoms.  She came to the hospital yesterday due to continued symptoms and return of shortness of breath. She additionally began experiencing headaches and double vision consistent with her migraines but definitely worse than her past headaches. She was admitted to the the ICU and evaluated by ENT with laryngoscopy (unremarkable). She was started on Methylprednisolone with racemic epinephrine. She has been started on treatment with Firazyr (icatibant) 30mg which has helped with tongue swelling.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diplopia, Dyspnoea, Fatigue, Headache, Intensive care
Clinical narrative: On April 5th, patient received the J&J covid vaccine from her PCP and admits to perioral itching approximately 10-15 minutes after receiving the vaccine. She believed her symptoms were secondary to eczema and went home after getting the vaccine. When she arrived home, she had developed both lip and tongue swelling. She called her primary care doctor and was recommended to take Benadryl 25mg and head to the ER. She felt very tired and instead of going to the ER she fell asleep. The next morning, she continued to experience perioral itching, lip swelling, and tongue swelling and went to a local emergency room where she was treated with IM epinephrine and discharged on pepsid/prednisone/benadryl. She noted improvement in her symptoms at this point and continued on Prednisone 40mg. However, one day later, she noticed the lip swelling and tongue swelling return and developed shortness of breath. She returned to the ER and was given IM epinephrine which helped her symptoms significantly. She was continued on Pepcid/Prednisone/Benadryl and discharged from the ER. Ultimately this continued for the last two weeks and last Friday, she was hospitalized at from April 16 to April 19. She was given racemic epinephrine and felt that was the most helpful in terms of alleviating her shortness of breath. While at hospital, she was started on Singulair, Zyrtec, Pepcid, and Benadryl.  She was evaluated by an Allergist on 4/19/21 and underwent an autoimmune workup (ANA, RF, ESR, CRP) and angioedema workup (C3, C4, C1INH, tryptase) which was reported as being unremarkable. She was also given a shot of Xolair however she has not noticed any improvement in her symptoms.  She came to the hospital yesterday due to continued symptoms and return of shortness of breath. She additionally began experiencing headaches and double vision consistent with her migraines but definitely worse than her past headaches. She was admitted to the the ICU and evaluated by ENT with laryngoscopy (unremarkable). She was started on Methylprednisolone with racemic epinephrine. She has been started on treatment with Firazyr (icatibant) 30mg which has helped with tongue swelling.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laryngoscopy normal, Lip swelling, Oral pruritus, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: On April 5th, patient received the J&J covid vaccine from her PCP and admits to perioral itching approximately 10-15 minutes after receiving the vaccine. She believed her symptoms were secondary to eczema and went home after getting the vaccine. When she arrived home, she had developed both lip and tongue swelling. She called her primary care doctor and was recommended to take Benadryl 25mg and head to the ER. She felt very tired and instead of going to the ER she fell asleep. The next morning, she continued to experience perioral itching, lip swelling, and tongue swelling and went to a local emergency room where she was treated with IM epinephrine and discharged on pepsid/prednisone/benadryl. She noted improvement in her symptoms at this point and continued on Prednisone 40mg. However, one day later, she noticed the lip swelling and tongue swelling return and developed shortness of breath. She returned to the ER and was given IM epinephrine which helped her symptoms significantly. She was continued on Pepcid/Prednisone/Benadryl and discharged from the ER. Ultimately this continued for the last two weeks and last Friday, she was hospitalized at from April 16 to April 19. She was given racemic epinephrine and felt that was the most helpful in terms of alleviating her shortness of breath. While at hospital, she was started on Singulair, Zyrtec, Pepcid, and Benadryl.  She was evaluated by an Allergist on 4/19/21 and underwent an autoimmune workup (ANA, RF, ESR, CRP) and angioedema workup (C3, C4, C1INH, tryptase) which was reported as being unremarkable. She was also given a shot of Xolair however she has not noticed any improvement in her symptoms.  She came to the hospital yesterday due to continued symptoms and return of shortness of breath. She additionally began experiencing headaches and double vision consistent with her migraines but definitely worse than her past headaches. She was admitted to the the ICU and evaluated by ENT with laryngoscopy (unremarkable). She was started on Methylprednisolone with racemic epinephrine. She has been started on treatment with Firazyr (icatibant) 30mg which has helped with tongue swelling.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Tryptase
Clinical narrative: On April 5th, patient received the J&J covid vaccine from her PCP and admits to perioral itching approximately 10-15 minutes after receiving the vaccine. She believed her symptoms were secondary to eczema and went home after getting the vaccine. When she arrived home, she had developed both lip and tongue swelling. She called her primary care doctor and was recommended to take Benadryl 25mg and head to the ER. She felt very tired and instead of going to the ER she fell asleep. The next morning, she continued to experience perioral itching, lip swelling, and tongue swelling and went to a local emergency room where she was treated with IM epinephrine and discharged on pepsid/prednisone/benadryl. She noted improvement in her symptoms at this point and continued on Prednisone 40mg. However, one day later, she noticed the lip swelling and tongue swelling return and developed shortness of breath. She returned to the ER and was given IM epinephrine which helped her symptoms significantly. She was continued on Pepcid/Prednisone/Benadryl and discharged from the ER. Ultimately this continued for the last two weeks and last Friday, she was hospitalized at from April 16 to April 19. She was given racemic epinephrine and felt that was the most helpful in terms of alleviating her shortness of breath. While at hospital, she was started on Singulair, Zyrtec, Pepcid, and Benadryl.  She was evaluated by an Allergist on 4/19/21 and underwent an autoimmune workup (ANA, RF, ESR, CRP) and angioedema workup (C3, C4, C1INH, tryptase) which was reported as being unremarkable. She was also given a shot of Xolair however she has not noticed any improvement in her symptoms.  She came to the hospital yesterday due to continued symptoms and return of shortness of breath. She additionally began experiencing headaches and double vision consistent with her migraines but definitely worse than her past headaches. She was admitted to the the ICU and evaluated by ENT with laryngoscopy (unremarkable). She was started on Methylprednisolone with racemic epinephrine. She has been started on treatment with Firazyr (icatibant) 30mg which has helped with tongue swelling.