chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dysphagia, Eye swelling, Mouth swelling, Oropharyngeal pain
Clinical narrative: Almost immediately after having the shot had feeling of tightness of the throat and some redness of the face. Refused an epipen shot but did take benadryl. Paramedics were called but did not go to the Emergency Room.  At all times could breath, just a tightness of the throat. Continued to take benadryl until I fell asleep that night, still had tightness of throat until I went to sleep. Woke up with a slight sore throat and some pain at injection site.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue, Tachycardia, Throat tightness
Clinical narrative: Almost immediately after having the shot had feeling of tightness of the throat and some redness of the face. Refused an epipen shot but did take benadryl. Paramedics were called but did not go to the Emergency Room.  At all times could breath, just a tightness of the throat. Continued to take benadryl until I fell asleep that night, still had tightness of throat until I went to sleep. Woke up with a slight sore throat and some pain at injection site.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Erythema, Injection site pain, Oropharyngeal pain, Throat tightness
Clinical narrative: Almost immediately after having the shot had feeling of tightness of the throat and some redness of the face. Refused an epipen shot but did take benadryl. Paramedics were called but did not go to the Emergency Room.  At all times could breath, just a tightness of the throat. Continued to take benadryl until I fell asleep that night, still had tightness of throat until I went to sleep. Woke up with a slight sore throat and some pain at injection site.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Nervousness, Respiratory distress
Clinical narrative: Within a minute of receiving vaccine short of breath, racing heart, dizziness. On-site nurse administered epi-pen and Benadryl called paramedic when heart rate and breathing could not be returned to normal. Additional Benadryl provided via injection. Taken by ambulance to ER.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Dizziness, Dyspnoea, Exercise electrocardiogram abnormal, Palpitations
Clinical narrative: Within a minute of receiving vaccine short of breath, racing heart, dizziness. On-site nurse administered epi-pen and Benadryl called paramedic when heart rate and breathing could not be returned to normal. Additional Benadryl provided via injection. Taken by ambulance to ER.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Communication disorder, Cyanosis, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE (Anaphylactic reaction, Anaphylactic reaction) 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction described as severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Gait inability, Malaise, Metamorphopsia, Nausea
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE (Anaphylactic reaction, Anaphylactic reaction) 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction described as severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cyanosis, Dizziness, Dyspnoea, Nausea
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE (Anaphylactic reaction, Anaphylactic reaction) 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction described as severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE (Anaphylactic reaction, Anaphylactic reaction) 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction described as severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE (Anaphylactic reaction, Anaphylactic reaction) 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction described as severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition) .
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Limb discomfort
Clinical narrative: This spontaneous report received from a pharmacist and concerned a patient of unspecified age and gender. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that, on 11-MAR-2021, after receiving the Janssen COVID19 vaccine the patient had blue coloured hands. Pharmacy staff was monitoring the patient and, the patient was further instructed to go to ER if condition worsened. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient had not recovered from blue coloured hands. The reporter considered the causality between COVID-19 vaccine AD26.COV2.S and blue coloured hands as related. Company causality between COVID-19 vaccine AD26.COV2.S and blue coloured hands was possible. This report was serious (Other Medically Important Condition).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: This spontaneous report received from a pharmacist and concerned a patient of unspecified age and gender. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that, on 11-MAR-2021, after receiving the Janssen COVID19 vaccine the patient had blue coloured hands. Pharmacy staff was monitoring the patient and, the patient was further instructed to go to ER if condition worsened. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient had not recovered from blue coloured hands. The reporter considered the causality between COVID-19 vaccine AD26.COV2.S and blue coloured hands as related. Company causality between COVID-19 vaccine AD26.COV2.S and blue coloured hands was possible. This report was serious (Other Medically Important Condition).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Fatigue, Influenza like illness, Joint swelling
Clinical narrative: extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain in extremity, Syncope
Clinical narrative: extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Erythema, Fatigue
Clinical narrative: extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gout, Headache, Hypokinesia, Joint swelling, Neck pain
Clinical narrative: extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Syncope, Tremor, Visual impairment
Clinical narrative: extreme pain in left side of neck with difficulty moving; fainted; dizziness; Extreme pain in left side of neck with difficulty moving; gout-like reaction in feet; arm pain; fatigue; weakness; body aches; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; left hand knuckles swelled turned red stiff and painful; headache; vision disturbances; shakiness; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old female patient (non-pregnant) received first dose BNT162B2 (Solution for injection, COVID 19, Pfizer, lot number: EN6198) via Intramuscular in Left arm on 04Mar2021 at 10: 45 at single dose for COVID-19 immunisation. Patient medical history included Gluten allergy. Concomitant medications included Phentermine, hydrochlorothiazide, ibuprofen. On 04Mar2021 at 16:00, patient had extreme pain in left side of neck with difficulty moving, gout-like reaction in feet, arm pain, fatigue, weakness, body aches, left hand knuckles swelled turned red stiff and painful, fainted, headache, vision disturbances, shakiness, dizziness. Adverse events was not resulted in Emergency room/department or urgent care. treatment was not given. No covid prior vaccination and no covid tested post vaccination. Outcome of events were not recovered.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the serious event, syncope cannot be completely ruled out.The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: I had gone to see my Dermatologist and showed her the injection site where it spread. The Dr. told me they have seen a lot of these, and stated it was an allergic reaction to the vaccine. She have me steroid cream to put on it, also told me it would take  about 6 weeks to heal.  It's still read and very itchy.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: I had gone to see my Dermatologist and showed her the injection site where it spread. The Dr. told me they have seen a lot of these, and stated it was an allergic reaction to the vaccine. She have me steroid cream to put on it, also told me it would take  about 6 weeks to heal.  It's still read and very itchy.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: On the day of getting the shot it burned badly. About an hour later a knot formed at the injection site and my skinned turned red. On March 12, my arm was still red, feverish and the knot was still present. I went to the doctor on March 15 where he examined the knot. It was still feverish sore to touch and starting to turn the color similar to a bruise. He put me on an antibiotic because it seemed infected. I finished the antibiotic and as of today March 30, the knot is still present. It doesn't hurt to touch it anymore but I still have a hard mass a little bigger than a quarter at the injection site and the bruising color is still present. I go for an ultra sound of the knot on tomorrow, March 31.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Erythema, Injection site nodule, Injection site pain, Pain of skin
Clinical narrative: On the day of getting the shot it burned badly. About an hour later a knot formed at the injection site and my skinned turned red. On March 12, my arm was still red, feverish and the knot was still present. I went to the doctor on March 15 where he examined the knot. It was still feverish sore to touch and starting to turn the color similar to a bruise. He put me on an antibiotic because it seemed infected. I finished the antibiotic and as of today March 30, the knot is still present. It doesn't hurt to touch it anymore but I still have a hard mass a little bigger than a quarter at the injection site and the bruising color is still present. I go for an ultra sound of the knot on tomorrow, March 31.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin warm, Ultrasound scan
Clinical narrative: On the day of getting the shot it burned badly. About an hour later a knot formed at the injection site and my skinned turned red. On March 12, my arm was still red, feverish and the knot was still present. I went to the doctor on March 15 where he examined the knot. It was still feverish sore to touch and starting to turn the color similar to a bruise. He put me on an antibiotic because it seemed infected. I finished the antibiotic and as of today March 30, the knot is still present. It doesn't hurt to touch it anymore but I still have a hard mass a little bigger than a quarter at the injection site and the bruising color is still present. I go for an ultra sound of the knot on tomorrow, March 31.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site nodule, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: On the day of getting the shot it burned badly. About an hour later a knot formed at the injection site and my skinned turned red. On March 12, my arm was still red, feverish and the knot was still present. I went to the doctor on March 15 where he examined the knot. It was still feverish sore to touch and starting to turn the color similar to a bruise. He put me on an antibiotic because it seemed infected. I finished the antibiotic and as of today March 30, the knot is still present. It doesn't hurt to touch it anymore but I still have a hard mass a little bigger than a quarter at the injection site and the bruising color is still present. I go for an ultra sound of the knot on tomorrow, March 31.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging head normal
Clinical narrative: Bell's Palsy
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: Day1- Cold sensation, felt tight throat when trying to swallow liquids; day 2- went to er at Regional Medical Center for chest pain, sob; went to PCP, reports that she has been having cold arms and leg (raynaud's like presentation) went to Hospital er twice,  now is in Regional Medical Center er with chest pain, headache, generalized weakness, reports that the cold sensations continue, patient was started on hctz after the vaccine for high BP, then amlodipine, patient was then taken off amlodipine and hctz and started on bystolic; tight senstions in the throat continue along with cold sensations; intermittent chest pains, headache
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Chest pain, Dyspnoea, Feeling cold
Clinical narrative: Day1- Cold sensation, felt tight throat when trying to swallow liquids; day 2- went to er at Regional Medical Center for chest pain, sob; went to PCP, reports that she has been having cold arms and leg (raynaud's like presentation) went to Hospital er twice,  now is in Regional Medical Center er with chest pain, headache, generalized weakness, reports that the cold sensations continue, patient was started on hctz after the vaccine for high BP, then amlodipine, patient was then taken off amlodipine and hctz and started on bystolic; tight senstions in the throat continue along with cold sensations; intermittent chest pains, headache
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Peripheral coldness, Throat tightness
Clinical narrative: Day1- Cold sensation, felt tight throat when trying to swallow liquids; day 2- went to er at Regional Medical Center for chest pain, sob; went to PCP, reports that she has been having cold arms and leg (raynaud's like presentation) went to Hospital er twice,  now is in Regional Medical Center er with chest pain, headache, generalized weakness, reports that the cold sensations continue, patient was started on hctz after the vaccine for high BP, then amlodipine, patient was then taken off amlodipine and hctz and started on bystolic; tight senstions in the throat continue along with cold sensations; intermittent chest pains, headache
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Culture urine negative, Dizziness, Dysgeusia
Clinical narrative: Pt passed out 5 min post vaccine. EMS was called and pt. transported to ED.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Laboratory test normal, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Pt passed out 5 min post vaccine. EMS was called and pt. transported to ED.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out 5 min post vaccine. EMS was called and pt. transported to ED.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiomegaly, Death, Headache, Hepatomegaly
Clinical narrative: Death - found dead at home
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Death, Toxicologic test, Tryptase
Clinical narrative: Death - found dead at home
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, IIIrd nerve paralysis
Clinical narrative: After vaccine, headache, sandy eyes, eventually blurred vision, drooping eyelids, eye closed and I was diagnosed with 3rd nerve ocular palsy of my left eye.  Referred to Ocular Neurologist.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Eyelid ptosis, Foreign body sensation in eyes, Headache, IIIrd nerve paralysis
Clinical narrative: After vaccine, headache, sandy eyes, eventually blurred vision, drooping eyelids, eye closed and I was diagnosed with 3rd nerve ocular palsy of my left eye.  Referred to Ocular Neurologist.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: After vaccine, headache, sandy eyes, eventually blurred vision, drooping eyelids, eye closed and I was diagnosed with 3rd nerve ocular palsy of my left eye.  Referred to Ocular Neurologist.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Foreign body sensation in eyes, Headache
Clinical narrative: After vaccine, headache, sandy eyes, eventually blurred vision, drooping eyelids, eye closed and I was diagnosed with 3rd nerve ocular palsy of my left eye.  Referred to Ocular Neurologist.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: Swollen face with pain and itching Ic Famotidine 20mg  twice a day Treatment Ic Cetirizine 10 mg once a day Benadryl 50 mg once a day
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Pruritus, Swelling face
Clinical narrative: Swollen face with pain and itching Ic Famotidine 20mg  twice a day Treatment Ic Cetirizine 10 mg once a day Benadryl 50 mg once a day
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Evening of 23 Mar 2021 felt a burning sensation in my joints.  Morning of 24 Mar 2021 had two brief instances of dizziness.  From 23-24 Mar 2021 left arm ached at injection sight.  On 25 & 26 Mar 2021 on left arm, approximately 4 inches below injection sight, and toward inside of arm there was a spot about 2 inches in diameter that was swollen, reddish, and ached and pulsed.  At 10:43 pm on 26 Mar 2021 I called my insurance provider's advice nurse.  She thought it could be an infection from getting the vaccine and recommended I visit an Urgent Care facility within 24 to 48 hours to have a medical professional check out the area.  The next day I went to an Urgent Care facility and the Nurse Practioner  didn't think it was anything to worry about.  Today, 30 Mar 2021 that area does not hurt, it is not swollen or discolored, but I can still feel a lump in that area on my left arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Evening of 23 Mar 2021 felt a burning sensation in my joints.  Morning of 24 Mar 2021 had two brief instances of dizziness.  From 23-24 Mar 2021 left arm ached at injection sight.  On 25 & 26 Mar 2021 on left arm, approximately 4 inches below injection sight, and toward inside of arm there was a spot about 2 inches in diameter that was swollen, reddish, and ached and pulsed.  At 10:43 pm on 26 Mar 2021 I called my insurance provider's advice nurse.  She thought it could be an infection from getting the vaccine and recommended I visit an Urgent Care facility within 24 to 48 hours to have a medical professional check out the area.  The next day I went to an Urgent Care facility and the Nurse Practioner  didn't think it was anything to worry about.  Today, 30 Mar 2021 that area does not hurt, it is not swollen or discolored, but I can still feel a lump in that area on my left arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Erythema, Injection site pain, Pain
Clinical narrative: Evening of 23 Mar 2021 felt a burning sensation in my joints.  Morning of 24 Mar 2021 had two brief instances of dizziness.  From 23-24 Mar 2021 left arm ached at injection sight.  On 25 & 26 Mar 2021 on left arm, approximately 4 inches below injection sight, and toward inside of arm there was a spot about 2 inches in diameter that was swollen, reddish, and ached and pulsed.  At 10:43 pm on 26 Mar 2021 I called my insurance provider's advice nurse.  She thought it could be an infection from getting the vaccine and recommended I visit an Urgent Care facility within 24 to 48 hours to have a medical professional check out the area.  The next day I went to an Urgent Care facility and the Nurse Practioner  didn't think it was anything to worry about.  Today, 30 Mar 2021 that area does not hurt, it is not swollen or discolored, but I can still feel a lump in that area on my left arm.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Evening of 23 Mar 2021 felt a burning sensation in my joints.  Morning of 24 Mar 2021 had two brief instances of dizziness.  From 23-24 Mar 2021 left arm ached at injection sight.  On 25 & 26 Mar 2021 on left arm, approximately 4 inches below injection sight, and toward inside of arm there was a spot about 2 inches in diameter that was swollen, reddish, and ached and pulsed.  At 10:43 pm on 26 Mar 2021 I called my insurance provider's advice nurse.  She thought it could be an infection from getting the vaccine and recommended I visit an Urgent Care facility within 24 to 48 hours to have a medical professional check out the area.  The next day I went to an Urgent Care facility and the Nurse Practioner  didn't think it was anything to worry about.  Today, 30 Mar 2021 that area does not hurt, it is not swollen or discolored, but I can still feel a lump in that area on my left arm.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Oral blood blister, Petechiae
Clinical narrative: Developed bruising and petechiae day after vaccine.  Found to have platelets of 9.  Concern for ITP
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Full blood count abnormal, Petechiae, Platelet count decreased
Clinical narrative: Developed bruising and petechiae day after vaccine.  Found to have platelets of 9.  Concern for ITP
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Contusion, Petechiae, SARS-CoV-2 test
Clinical narrative: Developed bruising and petechiae day after vaccine.  Found to have platelets of 9.  Concern for ITP
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: C/O DIZZINESS
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: C/O PAIN.  CHEST PAIN
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Palatal oedema
Clinical narrative: Angioedema, shortness of breath   Patient administered 50mg IM Benadryl and 0.3mg Epinephrine IM on site.  Ambulance transported stable patient to ED for further evaluation  ED Note: 51 y.o. female with past medical history of DM, GERD, TIA, HTN, migraine, PUD, angioedema, and anaphylaxis to multiple agents who presents with complaints of tongue and throat swelling following first Moderna vaccine.  Patient already received epinephrine and Benadryl at clinic, is having improvement in her symptoms with only slight voice change now, no residual shortness of breath or visualizable swelling.  Patient states she is feeling better.  Patient was provided with Pepcid and corticosteroids, was observed in the department for greater than 4 hours.  Patient had full resolution of her voice change.  Recommended that she follow-up with her primary care doctor, likely should not receive a second Covid shot but she discussed this with them.  Did discharge her on Medrol Dosepak.  Also recommended to the patient that she carry her EpiPen's at all times.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angioedema, Dysphonia, Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: Angioedema, shortness of breath   Patient administered 50mg IM Benadryl and 0.3mg Epinephrine IM on site.  Ambulance transported stable patient to ED for further evaluation  ED Note: 51 y.o. female with past medical history of DM, GERD, TIA, HTN, migraine, PUD, angioedema, and anaphylaxis to multiple agents who presents with complaints of tongue and throat swelling following first Moderna vaccine.  Patient already received epinephrine and Benadryl at clinic, is having improvement in her symptoms with only slight voice change now, no residual shortness of breath or visualizable swelling.  Patient states she is feeling better.  Patient was provided with Pepcid and corticosteroids, was observed in the department for greater than 4 hours.  Patient had full resolution of her voice change.  Recommended that she follow-up with her primary care doctor, likely should not receive a second Covid shot but she discussed this with them.  Did discharge her on Medrol Dosepak.  Also recommended to the patient that she carry her EpiPen's at all times.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Lip swelling
Clinical narrative: Angioedema, shortness of breath   Patient administered 50mg IM Benadryl and 0.3mg Epinephrine IM on site.  Ambulance transported stable patient to ED for further evaluation  ED Note: 51 y.o. female with past medical history of DM, GERD, TIA, HTN, migraine, PUD, angioedema, and anaphylaxis to multiple agents who presents with complaints of tongue and throat swelling following first Moderna vaccine.  Patient already received epinephrine and Benadryl at clinic, is having improvement in her symptoms with only slight voice change now, no residual shortness of breath or visualizable swelling.  Patient states she is feeling better.  Patient was provided with Pepcid and corticosteroids, was observed in the department for greater than 4 hours.  Patient had full resolution of her voice change.  Recommended that she follow-up with her primary care doctor, likely should not receive a second Covid shot but she discussed this with them.  Did discharge her on Medrol Dosepak.  Also recommended to the patient that she carry her EpiPen's at all times.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysphonia, Dyspnoea, Lip swelling, SARS-CoV-2 test negative
Clinical narrative: Angioedema, shortness of breath   Patient administered 50mg IM Benadryl and 0.3mg Epinephrine IM on site.  Ambulance transported stable patient to ED for further evaluation  ED Note: 51 y.o. female with past medical history of DM, GERD, TIA, HTN, migraine, PUD, angioedema, and anaphylaxis to multiple agents who presents with complaints of tongue and throat swelling following first Moderna vaccine.  Patient already received epinephrine and Benadryl at clinic, is having improvement in her symptoms with only slight voice change now, no residual shortness of breath or visualizable swelling.  Patient states she is feeling better.  Patient was provided with Pepcid and corticosteroids, was observed in the department for greater than 4 hours.  Patient had full resolution of her voice change.  Recommended that she follow-up with her primary care doctor, likely should not receive a second Covid shot but she discussed this with them.  Did discharge her on Medrol Dosepak.  Also recommended to the patient that she carry her EpiPen's at all times.
Sex: U
Vaccine: COVID19
Symptoms: Eye haemorrhage, Feeling abnormal, Hallucination, Heart rate abnormal, Muscle spasms
Clinical narrative: PROJECTILE BLEEDING FROM EYEBALLS; GRIZZLY SKELETONS PEER BACK; HEART MUSTERS A FAINT BEAT; SALIVA TASTES LIKE SOAPY PENNIES; FEELS LIKE SOMEONE WAS USING A DRILL BIT ON 3 SECTIONS OF THE SPINE.; VOMITED UP SPLEEN; SENDING MY MUSCLES INTO A VIOLENT SPAS; MY BONES FEEL LIKE A THOUSAND SMASHED BOTTLE SHARDS GRINDING AGAINST MY TISSUES, TEARING APART MY INARDS BEFORE LOCKING IN PLACE; TALCUM MERCURY COARSING THROUGH MY VEINS EVERY 2-3 SEC; This spontaneous report received from a patient via a company representative 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: Unknown) dose,1 total, start therapy date were not reported 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 an unspecified date, the subject experienced projectile bleeding from eyeballs, grizzly skeletons peer back, saliva tastes like soapy pennies, feels like someone was using a drill bit on 3 sections of the spine., vomited up spleen, heart musters a faint beat, sending my muscles into a violent spas, my bones feel like a thousand smashed bottle shards grinding against my tissues, tearing apart my inards before locking in place, and talcum mercury coarsing through my veins every 2-3 sec. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the projectile bleeding from eyeballs, saliva tastes like soapy pennies, feels like someone was using a drill bit on 3 sections of the spine., vomited up spleen, heart musters a faint beat, sending my muscles into a violent spas, grizzly skeletons peer back, my bones feel like a thousand smashed bottle shards grinding against my tissues, tearing apart my inards before locking in place and talcum mercury coarsing through my veins every 2-3 sec was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210329150-covid-19 vaccine ad26.cov2.s-projectile bleeding from eyeballs, grizzly skeletons peer bac. 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: U
Vaccine: COVID19
Symptoms: Pain, Spinal pain, Taste disorder, Vomiting
Clinical narrative: PROJECTILE BLEEDING FROM EYEBALLS; GRIZZLY SKELETONS PEER BACK; HEART MUSTERS A FAINT BEAT; SALIVA TASTES LIKE SOAPY PENNIES; FEELS LIKE SOMEONE WAS USING A DRILL BIT ON 3 SECTIONS OF THE SPINE.; VOMITED UP SPLEEN; SENDING MY MUSCLES INTO A VIOLENT SPAS; MY BONES FEEL LIKE A THOUSAND SMASHED BOTTLE SHARDS GRINDING AGAINST MY TISSUES, TEARING APART MY INARDS BEFORE LOCKING IN PLACE; TALCUM MERCURY COARSING THROUGH MY VEINS EVERY 2-3 SEC; This spontaneous report received from a patient via a company representative 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: Unknown) dose,1 total, start therapy date were not reported 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 an unspecified date, the subject experienced projectile bleeding from eyeballs, grizzly skeletons peer back, saliva tastes like soapy pennies, feels like someone was using a drill bit on 3 sections of the spine., vomited up spleen, heart musters a faint beat, sending my muscles into a violent spas, my bones feel like a thousand smashed bottle shards grinding against my tissues, tearing apart my inards before locking in place, and talcum mercury coarsing through my veins every 2-3 sec. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the projectile bleeding from eyeballs, saliva tastes like soapy pennies, feels like someone was using a drill bit on 3 sections of the spine., vomited up spleen, heart musters a faint beat, sending my muscles into a violent spas, grizzly skeletons peer back, my bones feel like a thousand smashed bottle shards grinding against my tissues, tearing apart my inards before locking in place and talcum mercury coarsing through my veins every 2-3 sec was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210329150-covid-19 vaccine ad26.cov2.s-projectile bleeding from eyeballs, grizzly skeletons peer bac. 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).