chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient recieved the Moderna Vaccine in her right arm around 9:15am. A couple hours later patient started to experience numbness up her right arm to her neck which traveled to the right side of her face. Patient described it as a heavy sensation in her face that lasted 24 hours. Numbness has not returned after 24 hours
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Hypoaesthesia
Clinical narrative: Patient recieved the Moderna Vaccine in her right arm around 9:15am. A couple hours later patient started to experience numbness up her right arm to her neck which traveled to the right side of her face. Patient described it as a heavy sensation in her face that lasted 24 hours. Numbness has not returned after 24 hours
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blister, Mobility decreased, Pain in extremity, Urticaria
Clinical narrative: patient states the day after vaccination she developed hard, blister like white bumps on her shoulder of her left arm.  They were not itchy and stayed present for several days later.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site rash, Injection site vesicles
Clinical narrative: patient states the day after vaccination she developed hard, blister like white bumps on her shoulder of her left arm.  They were not itchy and stayed present for several days later.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Bell's palsy, Computerised tomogram head, Full blood count, Metabolic function test
Clinical narrative: Acute onset of Bell's Palsy three weeks after receiving the Moderna COVID vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: Acute onset of Bell's Palsy three weeks after receiving the Moderna COVID vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral pruritus
Clinical narrative: Within 15 min had oral itchiness and puffy lips. Was given 25mg of benadryl. Within 48 hours had full body itchiness
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Oral disorder, Pruritus
Clinical narrative: Within 15 min had oral itchiness and puffy lips. Was given 25mg of benadryl. Within 48 hours had full body itchiness
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Brain death, Coma, Spinal artery thrombosis
Clinical narrative: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP; SLURRED SPEECH; MIGRAINES; FLU-LIKE SYMPTOMS; HEADACHES; This spontaneous report received from a consumer concerned his mother in law, 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) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the following day of vaccination the patient had flu-like symptoms and was feeling unwell. She began having headaches, migraines, slurred speech and was feeling more unwell. On 05-APR-2021, she could not keep her head up so she was taken to the Emergency room (ER) and once in the ER she was unable to talk, slurred words. Magnetic resonance imaging (MRI) completed on 05-APR-2021 in which a blood clot in spine was reported. Laboratory data included: MRI (NR: not provided) Blood clot in spine She was flown out to see a specialist and upon arrival specialist confirmed that they could not do anything to treat the blood clot. She was discharged from hospital to home to rest until she passed away two days later on 09-APR-2021 and no autopsy was completed at this time. On 09-APR-2021, the patient died from blood clot in spine, and difficulty keeping head up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Reporter stated events were all related to the vaccine. The patient had not recovered from blood clot in spine, flu-like symptoms, headaches, migraines and slurred speech. This report was serious (Death, Hospitalization and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who developed a blood clot in the spine 2 days after receiving the Janssen COVID-19 vaccine; she died due to the blood clot 4 days later.  No medical history or concomitant medications were reported. The patient developed flu-like symptoms, headache/migraine and slurred speech the day following vaccine administration, and could not keep her head up the next day.  She was brought to an ER, where an MRI revealed a blood clot in the spine.  She was transported to another hospital, and the family was told nothing could be done to treat the blood clot.  She was discharged and passed away at home due to the blood clot, 6 days after receiving the vaccine. There are insufficient details to make a meaningful medical assessment at this time.  Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Dysarthria, Headache, Influenza like illness, Magnetic resonance imaging, Migraine
Clinical narrative: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP; SLURRED SPEECH; MIGRAINES; FLU-LIKE SYMPTOMS; HEADACHES; This spontaneous report received from a consumer concerned his mother in law, 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) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the following day of vaccination the patient had flu-like symptoms and was feeling unwell. She began having headaches, migraines, slurred speech and was feeling more unwell. On 05-APR-2021, she could not keep her head up so she was taken to the Emergency room (ER) and once in the ER she was unable to talk, slurred words. Magnetic resonance imaging (MRI) completed on 05-APR-2021 in which a blood clot in spine was reported. Laboratory data included: MRI (NR: not provided) Blood clot in spine She was flown out to see a specialist and upon arrival specialist confirmed that they could not do anything to treat the blood clot. She was discharged from hospital to home to rest until she passed away two days later on 09-APR-2021 and no autopsy was completed at this time. On 09-APR-2021, the patient died from blood clot in spine, and difficulty keeping head up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Reporter stated events were all related to the vaccine. The patient had not recovered from blood clot in spine, flu-like symptoms, headaches, migraines and slurred speech. This report was serious (Death, Hospitalization and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who developed a blood clot in the spine 2 days after receiving the Janssen COVID-19 vaccine; she died due to the blood clot 4 days later.  No medical history or concomitant medications were reported. The patient developed flu-like symptoms, headache/migraine and slurred speech the day following vaccine administration, and could not keep her head up the next day.  She was brought to an ER, where an MRI revealed a blood clot in the spine.  She was transported to another hospital, and the family was told nothing could be done to treat the blood clot.  She was discharged and passed away at home due to the blood clot, 6 days after receiving the vaccine. There are insufficient details to make a meaningful medical assessment at this time.  Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Musculoskeletal disorder, Thrombosis
Clinical narrative: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP; SLURRED SPEECH; MIGRAINES; FLU-LIKE SYMPTOMS; HEADACHES; This spontaneous report received from a consumer concerned his mother in law, 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) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the following day of vaccination the patient had flu-like symptoms and was feeling unwell. She began having headaches, migraines, slurred speech and was feeling more unwell. On 05-APR-2021, she could not keep her head up so she was taken to the Emergency room (ER) and once in the ER she was unable to talk, slurred words. Magnetic resonance imaging (MRI) completed on 05-APR-2021 in which a blood clot in spine was reported. Laboratory data included: MRI (NR: not provided) Blood clot in spine She was flown out to see a specialist and upon arrival specialist confirmed that they could not do anything to treat the blood clot. She was discharged from hospital to home to rest until she passed away two days later on 09-APR-2021 and no autopsy was completed at this time. On 09-APR-2021, the patient died from blood clot in spine, and difficulty keeping head up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Reporter stated events were all related to the vaccine. The patient had not recovered from blood clot in spine, flu-like symptoms, headaches, migraines and slurred speech. This report was serious (Death, Hospitalization and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who developed a blood clot in the spine 2 days after receiving the Janssen COVID-19 vaccine; she died due to the blood clot 4 days later.  No medical history or concomitant medications were reported. The patient developed flu-like symptoms, headache/migraine and slurred speech the day following vaccine administration, and could not keep her head up the next day.  She was brought to an ER, where an MRI revealed a blood clot in the spine.  She was transported to another hospital, and the family was told nothing could be done to treat the blood clot.  She was discharged and passed away at home due to the blood clot, 6 days after receiving the vaccine. There are insufficient details to make a meaningful medical assessment at this time.  Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Asthenia, Death, Dysarthria, Fatigue, Gait disturbance
Clinical narrative: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP; SLURRED SPEECH; MIGRAINES; FLU-LIKE SYMPTOMS; HEADACHES; This spontaneous report received from a consumer concerned his mother in law, 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) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the following day of vaccination the patient had flu-like symptoms and was feeling unwell. She began having headaches, migraines, slurred speech and was feeling more unwell. On 05-APR-2021, she could not keep her head up so she was taken to the Emergency room (ER) and once in the ER she was unable to talk, slurred words. Magnetic resonance imaging (MRI) completed on 05-APR-2021 in which a blood clot in spine was reported. Laboratory data included: MRI (NR: not provided) Blood clot in spine She was flown out to see a specialist and upon arrival specialist confirmed that they could not do anything to treat the blood clot. She was discharged from hospital to home to rest until she passed away two days later on 09-APR-2021 and no autopsy was completed at this time. On 09-APR-2021, the patient died from blood clot in spine, and difficulty keeping head up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Reporter stated events were all related to the vaccine. The patient had not recovered from blood clot in spine, flu-like symptoms, headaches, migraines and slurred speech. This report was serious (Death, Hospitalization and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who developed a blood clot in the spine 2 days after receiving the Janssen COVID-19 vaccine; she died due to the blood clot 4 days later.  No medical history or concomitant medications were reported. The patient developed flu-like symptoms, headache/migraine and slurred speech the day following vaccine administration, and could not keep her head up the next day.  She was brought to an ER, where an MRI revealed a blood clot in the spine.  She was transported to another hospital, and the family was told nothing could be done to treat the blood clot.  She was discharged and passed away at home due to the blood clot, 6 days after receiving the vaccine. There are insufficient details to make a meaningful medical assessment at this time.  Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Headache, Loss of personal independence in daily activities, Magnetic resonance imaging spinal abnormal, Malaise, Nausea
Clinical narrative: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP; SLURRED SPEECH; MIGRAINES; FLU-LIKE SYMPTOMS; HEADACHES; This spontaneous report received from a consumer concerned his mother in law, 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) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the following day of vaccination the patient had flu-like symptoms and was feeling unwell. She began having headaches, migraines, slurred speech and was feeling more unwell. On 05-APR-2021, she could not keep her head up so she was taken to the Emergency room (ER) and once in the ER she was unable to talk, slurred words. Magnetic resonance imaging (MRI) completed on 05-APR-2021 in which a blood clot in spine was reported. Laboratory data included: MRI (NR: not provided) Blood clot in spine She was flown out to see a specialist and upon arrival specialist confirmed that they could not do anything to treat the blood clot. She was discharged from hospital to home to rest until she passed away two days later on 09-APR-2021 and no autopsy was completed at this time. On 09-APR-2021, the patient died from blood clot in spine, and difficulty keeping head up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Reporter stated events were all related to the vaccine. The patient had not recovered from blood clot in spine, flu-like symptoms, headaches, migraines and slurred speech. This report was serious (Death, Hospitalization and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who developed a blood clot in the spine 2 days after receiving the Janssen COVID-19 vaccine; she died due to the blood clot 4 days later.  No medical history or concomitant medications were reported. The patient developed flu-like symptoms, headache/migraine and slurred speech the day following vaccine administration, and could not keep her head up the next day.  She was brought to an ER, where an MRI revealed a blood clot in the spine.  She was transported to another hospital, and the family was told nothing could be done to treat the blood clot.  She was discharged and passed away at home due to the blood clot, 6 days after receiving the vaccine. There are insufficient details to make a meaningful medical assessment at this time.  Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Posture abnormal, Spinal artery embolism
Clinical narrative: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP; SLURRED SPEECH; MIGRAINES; FLU-LIKE SYMPTOMS; HEADACHES; This spontaneous report received from a consumer concerned his mother in law, 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) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the following day of vaccination the patient had flu-like symptoms and was feeling unwell. She began having headaches, migraines, slurred speech and was feeling more unwell. On 05-APR-2021, she could not keep her head up so she was taken to the Emergency room (ER) and once in the ER she was unable to talk, slurred words. Magnetic resonance imaging (MRI) completed on 05-APR-2021 in which a blood clot in spine was reported. Laboratory data included: MRI (NR: not provided) Blood clot in spine She was flown out to see a specialist and upon arrival specialist confirmed that they could not do anything to treat the blood clot. She was discharged from hospital to home to rest until she passed away two days later on 09-APR-2021 and no autopsy was completed at this time. On 09-APR-2021, the patient died from blood clot in spine, and difficulty keeping head up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Reporter stated events were all related to the vaccine. The patient had not recovered from blood clot in spine, flu-like symptoms, headaches, migraines and slurred speech. This report was serious (Death, Hospitalization and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who developed a blood clot in the spine 2 days after receiving the Janssen COVID-19 vaccine; she died due to the blood clot 4 days later.  No medical history or concomitant medications were reported. The patient developed flu-like symptoms, headache/migraine and slurred speech the day following vaccine administration, and could not keep her head up the next day.  She was brought to an ER, where an MRI revealed a blood clot in the spine.  She was transported to another hospital, and the family was told nothing could be done to treat the blood clot.  She was discharged and passed away at home due to the blood clot, 6 days after receiving the vaccine. There are insufficient details to make a meaningful medical assessment at this time.  Additional information has been requested.  The case will be assessed further when additional information is received.; Reported Cause(s) of Death: BLOOD CLOT IN SPINE; DIFFICULTY KEEPING HEAD UP
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dizziness, Heart rate increased, Nausea
Clinical narrative: Nausea, vomting, palpitations starting 10 minutes after vaccine administration.  Generalized Tonic Seizure 2 days after vaccine.  CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8.  MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Vomiting
Clinical narrative: Nausea, vomting, palpitations starting 10 minutes after vaccine administration.  Generalized Tonic Seizure 2 days after vaccine.  CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8.  MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Dysstasia, Electroencephalogram abnormal, Epilepsy, Generalised tonic-clonic seizure
Clinical narrative: Nausea, vomting, palpitations starting 10 minutes after vaccine administration.  Generalized Tonic Seizure 2 days after vaccine.  CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8.  MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Myoclonus, Nausea, Palpitations, Seizure prophylaxis
Clinical narrative: Nausea, vomting, palpitations starting 10 minutes after vaccine administration.  Generalized Tonic Seizure 2 days after vaccine.  CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8.  MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Nausea, vomting, palpitations starting 10 minutes after vaccine administration.  Generalized Tonic Seizure 2 days after vaccine.  CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8.  MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Immediate post-injection reaction, Respiratory distress
Clinical narrative: ANAPHYLACTIC REACTION; LIGHT HEADED; SYNCOPE/LOST CONSCIOUSNESS; STOPPED BREATHING; VOMITING/PERSISTENT EMESIS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and anaphylaxis to peanuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, after vaccination patient experienced an anaphylactic reaction. The patient was at her local pharmacy and was waiting in chairs as instructed; then she walked to her vehicle and began to feel light-headed and lost consciousness. Her husband was with her and was able to administer life saving measures, the local pharmacist was able to administer an epi-pen to her right thigh. On 02-APR-2021, the patient stopped breathing and was then transported to the local ER(emergency room) where she was treated. She regained consciousness and had persistent emesis and the patient was kept in hospital for 24 hours before being discharged. The patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/lost consciousness, and was recovering from light headed, vomiting/persistent emesis, and anaphylactic reaction, stopped breathing. This report was serious (Hospitalization Caused/ Prolonged, and Life Threatening).; Sender's Comments: v0 A 52-year-old female patient with the past medical history remarkable for anaphylaxis to peanuts experienced anaphylactic reaction the same day the Janssen COVID-19 Vaccine Ad26.COV2 was administered. The patient began to feel light-headed and lost consciousness, an epi-pen was administered. The next day the patient stopped breathing and was treated in the local ER (emergency room). Later she had persistent emesis. Given the close temporal relationship and history of anaphylaxis to peanuts the events are considered related.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Respiratory failure, Syncope
Clinical narrative: ANAPHYLACTIC REACTION; LIGHT HEADED; SYNCOPE/LOST CONSCIOUSNESS; STOPPED BREATHING; VOMITING/PERSISTENT EMESIS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and anaphylaxis to peanuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, after vaccination patient experienced an anaphylactic reaction. The patient was at her local pharmacy and was waiting in chairs as instructed; then she walked to her vehicle and began to feel light-headed and lost consciousness. Her husband was with her and was able to administer life saving measures, the local pharmacist was able to administer an epi-pen to her right thigh. On 02-APR-2021, the patient stopped breathing and was then transported to the local ER(emergency room) where she was treated. She regained consciousness and had persistent emesis and the patient was kept in hospital for 24 hours before being discharged. The patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/lost consciousness, and was recovering from light headed, vomiting/persistent emesis, and anaphylactic reaction, stopped breathing. This report was serious (Hospitalization Caused/ Prolonged, and Life Threatening).; Sender's Comments: v0 A 52-year-old female patient with the past medical history remarkable for anaphylaxis to peanuts experienced anaphylactic reaction the same day the Janssen COVID-19 Vaccine Ad26.COV2 was administered. The patient began to feel light-headed and lost consciousness, an epi-pen was administered. The next day the patient stopped breathing and was treated in the local ER (emergency room). Later she had persistent emesis. Given the close temporal relationship and history of anaphylaxis to peanuts the events are considered related.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Respiratory arrest, Syncope, Vomiting
Clinical narrative: ANAPHYLACTIC REACTION; LIGHT HEADED; SYNCOPE/LOST CONSCIOUSNESS; STOPPED BREATHING; VOMITING/PERSISTENT EMESIS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and anaphylaxis to peanuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 02-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, after vaccination patient experienced an anaphylactic reaction. The patient was at her local pharmacy and was waiting in chairs as instructed; then she walked to her vehicle and began to feel light-headed and lost consciousness. Her husband was with her and was able to administer life saving measures, the local pharmacist was able to administer an epi-pen to her right thigh. On 02-APR-2021, the patient stopped breathing and was then transported to the local ER(emergency room) where she was treated. She regained consciousness and had persistent emesis and the patient was kept in hospital for 24 hours before being discharged. The patient was hospitalized for one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope/lost consciousness, and was recovering from light headed, vomiting/persistent emesis, and anaphylactic reaction, stopped breathing. This report was serious (Hospitalization Caused/ Prolonged, and Life Threatening).; Sender's Comments: v0 A 52-year-old female patient with the past medical history remarkable for anaphylaxis to peanuts experienced anaphylactic reaction the same day the Janssen COVID-19 Vaccine Ad26.COV2 was administered. The patient began to feel light-headed and lost consciousness, an epi-pen was administered. The next day the patient stopped breathing and was treated in the local ER (emergency room). Later she had persistent emesis. Given the close temporal relationship and history of anaphylaxis to peanuts the events are considered related.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: MUSCLE SPASM; MUSCLE TREMORS; INCREASE BLOOD PRESSURE; HEART RAISING; LIGHT HEADED; RIGHT EYE TWITCHING; UNABLE TO EAT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced muscle tremors. On APR-2021, the subject experienced increase blood pressure. On APR-2021, the subject experienced heart raising. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced right eye twitching. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Increased, and Heart rate (NR: not provided) Increased. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle spasm, increase blood pressure, heart raising, headache, light headed, right eye twitching, nausea, unable to eat and muscle tremors was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: MUSCLE SPASM; MUSCLE TREMORS; INCREASE BLOOD PRESSURE; HEART RAISING; LIGHT HEADED; RIGHT EYE TWITCHING; UNABLE TO EAT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced muscle tremors. On APR-2021, the subject experienced increase blood pressure. On APR-2021, the subject experienced heart raising. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced right eye twitching. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Increased, and Heart rate (NR: not provided) Increased. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle spasm, increase blood pressure, heart raising, headache, light headed, right eye twitching, nausea, unable to eat and muscle tremors was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Blood pressure increased, Blood pressure measurement, Dizziness, Feeding disorder
Clinical narrative: MUSCLE SPASM; MUSCLE TREMORS; INCREASE BLOOD PRESSURE; HEART RAISING; LIGHT HEADED; RIGHT EYE TWITCHING; UNABLE TO EAT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced muscle tremors. On APR-2021, the subject experienced increase blood pressure. On APR-2021, the subject experienced heart raising. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced right eye twitching. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Increased, and Heart rate (NR: not provided) Increased. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle spasm, increase blood pressure, heart raising, headache, light headed, right eye twitching, nausea, unable to eat and muscle tremors was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Muscle spasms, Nausea
Clinical narrative: MUSCLE SPASM; MUSCLE TREMORS; INCREASE BLOOD PRESSURE; HEART RAISING; LIGHT HEADED; RIGHT EYE TWITCHING; UNABLE TO EAT; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced muscle tremors. On APR-2021, the subject experienced increase blood pressure. On APR-2021, the subject experienced heart raising. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced right eye twitching. On APR-2021, the subject experienced unable to eat. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Blood pressure (NR: not provided) Increased, and Heart rate (NR: not provided) Increased. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle spasm, increase blood pressure, heart raising, headache, light headed, right eye twitching, nausea, unable to eat and muscle tremors was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This is a case of a 44 yo female, previously in excellent health with no chronic medical problems, no maintenance medications or use of herbal or supplementary medications.  She has a previous allergy to Cipro and has recently been advised that she should consider herself to be allergic to all sulfa products.    Approximately 1 week after patient received 1st dose of Moderna mRNA vaccine, she experienced a new onset diffuse rash over arms and swelling of right arm around injection site as well as painful oral lesions.  She sought care at a local Urgent Care and was treated with oral prednisone and Septra with no improvement and actually developed worsening symptoms.  She then sought care with her PCM and was placed on another regimen of oral steroids and discontinued from the sulfa meds.   Her PCM diagnosed her with Stevens-Johnson Syndrome and referred her to Dermatologist.  Dermatologist concurred with the diagnosis of SJS and continued her on the steroids and referred her to Rheumatology which is still pending.  According to the patient, she has had an ANA, CMP, CBC  drawn with all normal results.  She is unaware of any other autoimmune studies or inflammatory markers being performed.  No biopsies were collected.  The diagnosis of SJS was made off clinical presentation.    At this time, patient is complaining of swelling of the bilateral upper extremities, especially of the hands.  She is also experiencing diffuse red rash over her upper extremities. sloughing of her oral mucosa with open painful lesions in her mouth and palate, diffuse joint pain and occasional intermittent fevers.  She denies any ocular involvement, nasal mucosa involvement or sloughing of any other dermal tissue.  She continues to take her oral prednisone and is still pending a Rheumatology evaluation.   This provider and clinic was notified of the patients condition on 4/22/2021 when the patients supervisor called to inform the medical department that the employee had been of work since 4/1/2021.  No previous information or contact had been made prior to submission of this report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash macular, Skin irritation, Vaginal infection, Vulvovaginal pain
Clinical narrative: This is a case of a 44 yo female, previously in excellent health with no chronic medical problems, no maintenance medications or use of herbal or supplementary medications.  She has a previous allergy to Cipro and has recently been advised that she should consider herself to be allergic to all sulfa products.    Approximately 1 week after patient received 1st dose of Moderna mRNA vaccine, she experienced a new onset diffuse rash over arms and swelling of right arm around injection site as well as painful oral lesions.  She sought care at a local Urgent Care and was treated with oral prednisone and Septra with no improvement and actually developed worsening symptoms.  She then sought care with her PCM and was placed on another regimen of oral steroids and discontinued from the sulfa meds.   Her PCM diagnosed her with Stevens-Johnson Syndrome and referred her to Dermatologist.  Dermatologist concurred with the diagnosis of SJS and continued her on the steroids and referred her to Rheumatology which is still pending.  According to the patient, she has had an ANA, CMP, CBC  drawn with all normal results.  She is unaware of any other autoimmune studies or inflammatory markers being performed.  No biopsies were collected.  The diagnosis of SJS was made off clinical presentation.    At this time, patient is complaining of swelling of the bilateral upper extremities, especially of the hands.  She is also experiencing diffuse red rash over her upper extremities. sloughing of her oral mucosa with open painful lesions in her mouth and palate, diffuse joint pain and occasional intermittent fevers.  She denies any ocular involvement, nasal mucosa involvement or sloughing of any other dermal tissue.  She continues to take her oral prednisone and is still pending a Rheumatology evaluation.   This provider and clinic was notified of the patients condition on 4/22/2021 when the patients supervisor called to inform the medical department that the employee had been of work since 4/1/2021.  No previous information or contact had been made prior to submission of this report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Arthralgia, Full blood count normal, Injection site swelling, Metabolic function test
Clinical narrative: This is a case of a 44 yo female, previously in excellent health with no chronic medical problems, no maintenance medications or use of herbal or supplementary medications.  She has a previous allergy to Cipro and has recently been advised that she should consider herself to be allergic to all sulfa products.    Approximately 1 week after patient received 1st dose of Moderna mRNA vaccine, she experienced a new onset diffuse rash over arms and swelling of right arm around injection site as well as painful oral lesions.  She sought care at a local Urgent Care and was treated with oral prednisone and Septra with no improvement and actually developed worsening symptoms.  She then sought care with her PCM and was placed on another regimen of oral steroids and discontinued from the sulfa meds.   Her PCM diagnosed her with Stevens-Johnson Syndrome and referred her to Dermatologist.  Dermatologist concurred with the diagnosis of SJS and continued her on the steroids and referred her to Rheumatology which is still pending.  According to the patient, she has had an ANA, CMP, CBC  drawn with all normal results.  She is unaware of any other autoimmune studies or inflammatory markers being performed.  No biopsies were collected.  The diagnosis of SJS was made off clinical presentation.    At this time, patient is complaining of swelling of the bilateral upper extremities, especially of the hands.  She is also experiencing diffuse red rash over her upper extremities. sloughing of her oral mucosa with open painful lesions in her mouth and palate, diffuse joint pain and occasional intermittent fevers.  She denies any ocular involvement, nasal mucosa involvement or sloughing of any other dermal tissue.  She continues to take her oral prednisone and is still pending a Rheumatology evaluation.   This provider and clinic was notified of the patients condition on 4/22/2021 when the patients supervisor called to inform the medical department that the employee had been of work since 4/1/2021.  No previous information or contact had been made prior to submission of this report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral disorder, Oral mucosal exfoliation, Oral pain, Peripheral swelling, Pyrexia
Clinical narrative: This is a case of a 44 yo female, previously in excellent health with no chronic medical problems, no maintenance medications or use of herbal or supplementary medications.  She has a previous allergy to Cipro and has recently been advised that she should consider herself to be allergic to all sulfa products.    Approximately 1 week after patient received 1st dose of Moderna mRNA vaccine, she experienced a new onset diffuse rash over arms and swelling of right arm around injection site as well as painful oral lesions.  She sought care at a local Urgent Care and was treated with oral prednisone and Septra with no improvement and actually developed worsening symptoms.  She then sought care with her PCM and was placed on another regimen of oral steroids and discontinued from the sulfa meds.   Her PCM diagnosed her with Stevens-Johnson Syndrome and referred her to Dermatologist.  Dermatologist concurred with the diagnosis of SJS and continued her on the steroids and referred her to Rheumatology which is still pending.  According to the patient, she has had an ANA, CMP, CBC  drawn with all normal results.  She is unaware of any other autoimmune studies or inflammatory markers being performed.  No biopsies were collected.  The diagnosis of SJS was made off clinical presentation.    At this time, patient is complaining of swelling of the bilateral upper extremities, especially of the hands.  She is also experiencing diffuse red rash over her upper extremities. sloughing of her oral mucosa with open painful lesions in her mouth and palate, diffuse joint pain and occasional intermittent fevers.  She denies any ocular involvement, nasal mucosa involvement or sloughing of any other dermal tissue.  She continues to take her oral prednisone and is still pending a Rheumatology evaluation.   This provider and clinic was notified of the patients condition on 4/22/2021 when the patients supervisor called to inform the medical department that the employee had been of work since 4/1/2021.  No previous information or contact had been made prior to submission of this report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Stevens-Johnson syndrome
Clinical narrative: This is a case of a 44 yo female, previously in excellent health with no chronic medical problems, no maintenance medications or use of herbal or supplementary medications.  She has a previous allergy to Cipro and has recently been advised that she should consider herself to be allergic to all sulfa products.    Approximately 1 week after patient received 1st dose of Moderna mRNA vaccine, she experienced a new onset diffuse rash over arms and swelling of right arm around injection site as well as painful oral lesions.  She sought care at a local Urgent Care and was treated with oral prednisone and Septra with no improvement and actually developed worsening symptoms.  She then sought care with her PCM and was placed on another regimen of oral steroids and discontinued from the sulfa meds.   Her PCM diagnosed her with Stevens-Johnson Syndrome and referred her to Dermatologist.  Dermatologist concurred with the diagnosis of SJS and continued her on the steroids and referred her to Rheumatology which is still pending.  According to the patient, she has had an ANA, CMP, CBC  drawn with all normal results.  She is unaware of any other autoimmune studies or inflammatory markers being performed.  No biopsies were collected.  The diagnosis of SJS was made off clinical presentation.    At this time, patient is complaining of swelling of the bilateral upper extremities, especially of the hands.  She is also experiencing diffuse red rash over her upper extremities. sloughing of her oral mucosa with open painful lesions in her mouth and palate, diffuse joint pain and occasional intermittent fevers.  She denies any ocular involvement, nasal mucosa involvement or sloughing of any other dermal tissue.  She continues to take her oral prednisone and is still pending a Rheumatology evaluation.   This provider and clinic was notified of the patients condition on 4/22/2021 when the patients supervisor called to inform the medical department that the employee had been of work since 4/1/2021.  No previous information or contact had been made prior to submission of this report.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gout
Clinical narrative: Continual Gout Flare since day vaccine was given
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood uric acid increased, Gout, X-ray
Clinical narrative: Continual Gout Flare since day vaccine was given