chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Peripheral swelling, Rash, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently  with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol.  Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently  with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol.  Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: Tingles two minutes post injection in both arms from elbows down to finger tips, vertigo 24 hours later as well as sore muscles/body aches, headaches and fatigue. Was mostly fine after 48 hours save for the fatigue; however, nausea started again on 03/31/2021
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Tingles two minutes post injection in both arms from elbows down to finger tips, vertigo 24 hours later as well as sore muscles/body aches, headaches and fatigue. Was mostly fine after 48 hours save for the fatigue; however, nausea started again on 03/31/2021
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: Tingles two minutes post injection in both arms from elbows down to finger tips, vertigo 24 hours later as well as sore muscles/body aches, headaches and fatigue. Was mostly fine after 48 hours save for the fatigue; however, nausea started again on 03/31/2021
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Throat irritation
Clinical narrative: I is a 47 year old female who has completed a 50 -minute observation period with the following signs and symptoms of an adverse reaction: diffuse hives or skin rash and sensation of throat swelling or throat closure. Noted redness to rt ear, and pt sts she feels throat dryness irritation and swelling. No wheezing noted. O2 at room air was 98. Elevated bp noted.  Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Consulted with doctor, pt evaluated.  o Solumedrol 125 mg and Benadryl 50 mg ordered. GIVEN.  o  Another drug administered - Solumedrol 125 mg  IM x 1,  Benadryl 50 mg given IM  o Pt felt a little anxious d/t fear of needles, pt reclined in chair and given o2.  o Pt sts this felt better.  o Bp rechecked was wnl.  o Pt sat back up and sts feels better now.  o   o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o   o Patient advised to discuss second dose considerations with a clinician. DOCTOR ADVISED ALLERGY ORDERED.  o   Pt sts she feels a lot better now. Skin  Redness rash has resolved and throat tightness has resolved.  Pt sts she feels a lot better now. Advised if condition worsens, sob, cp, rash, facial swelling,vomiting, abd pain, wheezing, she is to be taken to ED or call emergency responders. Pt verbalized understanding and agrees with plan. Doctor advised allergy ordered.  Documented allergic reaction in allergy activity.  Pt evaluated by the doctor.  Pt in stable condition and discharged home with Daughter.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Anxiety disorder, COVID-19, Dry throat, Erythema
Clinical narrative: I is a 47 year old female who has completed a 50 -minute observation period with the following signs and symptoms of an adverse reaction: diffuse hives or skin rash and sensation of throat swelling or throat closure. Noted redness to rt ear, and pt sts she feels throat dryness irritation and swelling. No wheezing noted. O2 at room air was 98. Elevated bp noted.  Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Consulted with doctor, pt evaluated.  o Solumedrol 125 mg and Benadryl 50 mg ordered. GIVEN.  o  Another drug administered - Solumedrol 125 mg  IM x 1,  Benadryl 50 mg given IM  o Pt felt a little anxious d/t fear of needles, pt reclined in chair and given o2.  o Pt sts this felt better.  o Bp rechecked was wnl.  o Pt sat back up and sts feels better now.  o   o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o   o Patient advised to discuss second dose considerations with a clinician. DOCTOR ADVISED ALLERGY ORDERED.  o   Pt sts she feels a lot better now. Skin  Redness rash has resolved and throat tightness has resolved.  Pt sts she feels a lot better now. Advised if condition worsens, sob, cp, rash, facial swelling,vomiting, abd pain, wheezing, she is to be taken to ED or call emergency responders. Pt verbalized understanding and agrees with plan. Doctor advised allergy ordered.  Documented allergic reaction in allergy activity.  Pt evaluated by the doctor.  Pt in stable condition and discharged home with Daughter.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear of injection, Pharyngeal swelling, Rash, Throat irritation, Throat tightness
Clinical narrative: I is a 47 year old female who has completed a 50 -minute observation period with the following signs and symptoms of an adverse reaction: diffuse hives or skin rash and sensation of throat swelling or throat closure. Noted redness to rt ear, and pt sts she feels throat dryness irritation and swelling. No wheezing noted. O2 at room air was 98. Elevated bp noted.  Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Consulted with doctor, pt evaluated.  o Solumedrol 125 mg and Benadryl 50 mg ordered. GIVEN.  o  Another drug administered - Solumedrol 125 mg  IM x 1,  Benadryl 50 mg given IM  o Pt felt a little anxious d/t fear of needles, pt reclined in chair and given o2.  o Pt sts this felt better.  o Bp rechecked was wnl.  o Pt sat back up and sts feels better now.  o   o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o   o Patient advised to discuss second dose considerations with a clinician. DOCTOR ADVISED ALLERGY ORDERED.  o   Pt sts she feels a lot better now. Skin  Redness rash has resolved and throat tightness has resolved.  Pt sts she feels a lot better now. Advised if condition worsens, sob, cp, rash, facial swelling,vomiting, abd pain, wheezing, she is to be taken to ED or call emergency responders. Pt verbalized understanding and agrees with plan. Doctor advised allergy ordered.  Documented allergic reaction in allergy activity.  Pt evaluated by the doctor.  Pt in stable condition and discharged home with Daughter.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: I is a 47 year old female who has completed a 50 -minute observation period with the following signs and symptoms of an adverse reaction: diffuse hives or skin rash and sensation of throat swelling or throat closure. Noted redness to rt ear, and pt sts she feels throat dryness irritation and swelling. No wheezing noted. O2 at room air was 98. Elevated bp noted.  Moderna COVID-19 vaccine# 1 in series administered.  o Action(s) taken: Consulted with doctor, pt evaluated.  o Solumedrol 125 mg and Benadryl 50 mg ordered. GIVEN.  o  Another drug administered - Solumedrol 125 mg  IM x 1,  Benadryl 50 mg given IM  o Pt felt a little anxious d/t fear of needles, pt reclined in chair and given o2.  o Pt sts this felt better.  o Bp rechecked was wnl.  o Pt sat back up and sts feels better now.  o   o Allergy to COVID-19 vaccine documented in Allergies activity: Yes o   o Patient advised to discuss second dose considerations with a clinician. DOCTOR ADVISED ALLERGY ORDERED.  o   Pt sts she feels a lot better now. Skin  Redness rash has resolved and throat tightness has resolved.  Pt sts she feels a lot better now. Advised if condition worsens, sob, cp, rash, facial swelling,vomiting, abd pain, wheezing, she is to be taken to ED or call emergency responders. Pt verbalized understanding and agrees with plan. Doctor advised allergy ordered.  Documented allergic reaction in allergy activity.  Pt evaluated by the doctor.  Pt in stable condition and discharged home with Daughter.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Feeling abnormal, Hallucination
Clinical narrative: Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then severe joint pain, O2 sat 91-94% on Room air, Went to bed, the next AM same symptoms but also experienced increased weakness unable to stand feeling like she was blacking out, almost had a fall, layed down then had involuntary muscle spasms, very weak and then headache. This lasted through the day 3/26/2021. Better the following day 3/27 but still felt some weakness through 3/28.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of consciousness, Movement disorder, Pain in extremity, Restlessness
Clinical narrative: Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then severe joint pain, O2 sat 91-94% on Room air, Went to bed, the next AM same symptoms but also experienced increased weakness unable to stand feeling like she was blacking out, almost had a fall, layed down then had involuntary muscle spasms, very weak and then headache. This lasted through the day 3/26/2021. Better the following day 3/27 but still felt some weakness through 3/28.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then severe joint pain, O2 sat 91-94% on Room air, Went to bed, the next AM same symptoms but also experienced increased weakness unable to stand feeling like she was blacking out, almost had a fall, layed down then had involuntary muscle spasms, very weak and then headache. This lasted through the day 3/26/2021. Better the following day 3/27 but still felt some weakness through 3/28.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Headache, Muscle spasms
Clinical narrative: Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then severe joint pain, O2 sat 91-94% on Room air, Went to bed, the next AM same symptoms but also experienced increased weakness unable to stand feeling like she was blacking out, almost had a fall, layed down then had involuntary muscle spasms, very weak and then headache. This lasted through the day 3/26/2021. Better the following day 3/27 but still felt some weakness through 3/28.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Presyncope
Clinical narrative: Patient reports symptoms starting a few hours after vaccination, started with chest heaviness, then severe joint pain, O2 sat 91-94% on Room air, Went to bed, the next AM same symptoms but also experienced increased weakness unable to stand feeling like she was blacking out, almost had a fall, layed down then had involuntary muscle spasms, very weak and then headache. This lasted through the day 3/26/2021. Better the following day 3/27 but still felt some weakness through 3/28.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Bilevel positive airway pressure, Blood culture, Brain natriuretic peptide increased, Bronchoscopy
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure acute, Chest X-ray, Computerised tomogram abnormal, Computerised tomogram head, Condition aggravated
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Culture urine, Death, Diarrhoea, Differential white blood cell count, Dyspnoea
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Hypotension, Intensive care, International normalised ratio
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipase, Mechanical ventilation, Metabolic function test, Nausea, Pneumonitis
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polyuria, Red blood cell sedimentation rate, SARS-CoV-2 antibody test, SARS-CoV-2 test, Scan with contrast
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory distress syndrome
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME (LOWER RESPIRATORY SYMPTOMS, PNEUMONITIS ON IMAGING AND BRONCHOSCOPY, FLUID IN THE LUNGS, HYPOXIA SPO2 IN THE 80S, COUGH AND NAUSEA); This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced acute respiratory distress syndrome, fluid in the lungs, and hypoxia spo2 in the 80s. On 10-MAR-2021, the patient experienced lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, cough and nausea. On 11-MAR-2021, the patient was presented to emergency room. On 11-MAR-2021, the patient was hospitalized. The patient was hospitalized for 14 days. It was reported that the patient had been intubated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory distress syndrome (lower respiratory symptoms, pneumonitis on imaging and bronchoscopy, fluid in the lungs, hypoxia spo2 in the 80s, cough and nausea). This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210348785-covid-19 vaccine ad26.cov2.s -Acute respiratory distress syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash pustular, Skin burning sensation, Skin erosion
Clinical narrative: Severe rash started day after shot with blistering. Progressing over several days. Not recovered yet. Not hospitalized.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Rash
Clinical narrative: Severe rash started day after shot with blistering. Progressing over several days. Not recovered yet. Not hospitalized.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Systemic: Joint Pain-Severe, Additional Details: Pt states that the day after the 2nd dose he has full body ache which was expected. But, the next day and 2 days after, the pt states that the pain, along with noticable swelling localized in his left knee.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Pain
Clinical narrative: Systemic: Joint Pain-Severe, Additional Details: Pt states that the day after the 2nd dose he has full body ache which was expected. But, the next day and 2 days after, the pt states that the pain, along with noticable swelling localized in his left knee.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: On my first visit on 3/4/21 I was given the Moderna lot number 025A21A......When I went in for my second series on 3/29/21 I was given PFIZER lot number ER8732. Prior to getting this second shot I had been verified several times and my wife was there at the same time at the same table also getting her second shot. When I went to sit and wait the 15 minutes, a representative came to me and ask to speak in privacy. She advised me that there had been a mistake and you were given PFIZER not MODERNA. I need your card to mark it right. I advised her that I was extremely upset and confused since all of this is so new.....I then asked her if this had ever happened before here and she advised me yes it has happened to a total of 3 people. i was shocked to hear this...i am experiencing left buttocks and left leg discomfort.....After my first shot I had NO side effects......Am I worried, yes.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Limb discomfort, Musculoskeletal pain
Clinical narrative: On my first visit on 3/4/21 I was given the Moderna lot number 025A21A......When I went in for my second series on 3/29/21 I was given PFIZER lot number ER8732. Prior to getting this second shot I had been verified several times and my wife was there at the same time at the same table also getting her second shot. When I went to sit and wait the 15 minutes, a representative came to me and ask to speak in privacy. She advised me that there had been a mistake and you were given PFIZER not MODERNA. I need your card to mark it right. I advised her that I was extremely upset and confused since all of this is so new.....I then asked her if this had ever happened before here and she advised me yes it has happened to a total of 3 people. i was shocked to hear this...i am experiencing left buttocks and left leg discomfort.....After my first shot I had NO side effects......Am I worried, yes.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: WORSENING OF FLUID IN THE LUNG; WORSENING OF LOW OXYGEN LEVEL; HARD TO BREATH WORSENING; TIRED; SWOLLEN FACE; VOMITING; NAUSEA; PAIN IN THE HEAD; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and tired was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210321906-Covid-19 Vaccine Ad26.Cov2.S-Worsening Of Low Oxygen Level, Hard To Breath Worsening, Worsening Of Fluid In The Lung. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pulmonary oedema, Swelling face, Vomiting
Clinical narrative: WORSENING OF FLUID IN THE LUNG; WORSENING OF LOW OXYGEN LEVEL; HARD TO BREATH WORSENING; TIRED; SWOLLEN FACE; VOMITING; NAUSEA; PAIN IN THE HEAD; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and tired was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210321906-Covid-19 Vaccine Ad26.Cov2.S-Worsening Of Low Oxygen Level, Hard To Breath Worsening, Worsening Of Fluid In The Lung. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Oxygen saturation
Clinical narrative: WORSENING OF FLUID IN THE LUNG; WORSENING OF LOW OXYGEN LEVEL; HARD TO BREATH WORSENING; TIRED; SWOLLEN FACE; VOMITING; NAUSEA; PAIN IN THE HEAD; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD), heart condition, neuropathy, and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the patient started symptoms and was tired. The patient had swollen face, nausea, vomiting and pain in the head. On 10-MAR-2021, the patient's symptoms got worse which included worsening of fluid in the lung, worsening of low oxygen level, hard to breath worsening and was admitted to the hospital. The patient was in hospital at the time of this report.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from worsening of low oxygen level, swollen face, and worsening of fluid in the lung, had not recovered from hard to breath worsening, and the outcome of nausea, vomiting, pain in the head and tired was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210321906-Covid-19 Vaccine Ad26.Cov2.S-Worsening Of Low Oxygen Level, Hard To Breath Worsening, Worsening Of Fluid In The Lung. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Dyspnoea, Hypotension
Clinical narrative: BLOOD PRESSURE TANKED TO 80/60; OUT OF BREATH; LIGHT HEADED/DIZZY; BACK PAINS; This spontaneous report received from a male patient of unspecified age reporting on self. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient had back pains (back pain) and took his pain medication. The patient mentioned that he had friends over today and served alcohol, the patient took a sip of the alcohol and immediately felt light headed; winded; out of breath (shortness of breath); dizzy and his blood pressure tanked to 80/60 (low blood pressure). He took the vaccine on his right arm and at the health department. As he was speaking, he was still feeling out of breath. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Low (80/60) (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, shortness of breath, light headed, and low blood pressure, and the outcome of back pain was not reported. The reporter considered the causality between JNJ-78436735, and dizzy, shortness of breath, light headed, and low blood pressure as related. The reporter considered the causality between JNJ-78436735, and back pain as possible. Company causality between JNJ-78436735, and dizzy, shortness of breath, light headed, and low blood pressure, and back pain was possible  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210326851-COVID-19 VACCINE AD26.COV2.S-low blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia, Pharyngeal swelling, Throat irritation
Clinical narrative: Reaction started 10-15min following vaccine. She experienced itchy throat followed by throat swelling on left side. No difficulty breathing but with some difficulty swallowing. Treated with 50mg benadryl and observed for 60min before going home in stable state. Throat itchy resolved 24hr later
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pharyngeal swelling, Throat irritation
Clinical narrative: Reaction started 10-15min following vaccine. She experienced itchy throat followed by throat swelling on left side. No difficulty breathing but with some difficulty swallowing. Treated with 50mg benadryl and observed for 60min before going home in stable state. Throat itchy resolved 24hr later
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Acute hepatic failure, Acute kidney injury, Blood test, Chills
Clinical narrative: rhabdomyolysis, elevated LFT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fluid retention, Gastric dilatation, Headache, Malaise
Clinical narrative: rhabdomyolysis, elevated LFT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Ultrasound abdomen abnormal
Clinical narrative: rhabdomyolysis, elevated LFT
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Blood creatinine, Liver function test increased, Rhabdomyolysis
Clinical narrative: rhabdomyolysis, elevated LFT
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Hypertension, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Vaccine was not placed in L deltoid, instead was placed mid bicep and caused a local erythematous swelling with itching/pain
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site swelling
Clinical narrative: Vaccine was not placed in L deltoid, instead was placed mid bicep and caused a local erythematous swelling with itching/pain
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Product administered at inappropriate site, Skin warm
Clinical narrative: Vaccine was not placed in L deltoid, instead was placed mid bicep and caused a local erythematous swelling with itching/pain
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Incorrect route of product administration, Pain, Pruritus, Swelling
Clinical narrative: Vaccine was not placed in L deltoid, instead was placed mid bicep and caused a local erythematous swelling with itching/pain
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Patient developed a Right Basal Ganglia CVA about 3 days after first dose of Moderna.  She developed left leg weakness which was stable at the time of hospital discharge.  She notified us at the time of her appointment for her 2nd vaccine and it was not given due to concerns about adverse reaction to initial dose.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basal ganglia stroke, Incomplete course of vaccination, Magnetic resonance imaging abnormal, Muscular weakness, Vaccination complication
Clinical narrative: Patient developed a Right Basal Ganglia CVA about 3 days after first dose of Moderna.  She developed left leg weakness which was stable at the time of hospital discharge.  She notified us at the time of her appointment for her 2nd vaccine and it was not given due to concerns about adverse reaction to initial dose.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral small vessel ischaemic disease, Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: Patient suffered a Right Thalamic CVA about 30 days after the first dose of Moderna.  Patient received tPA but has some mild residual deficits (facial droop).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging head abnormal, Plasminogen, Thalamic infarction
Clinical narrative: Patient suffered a Right Thalamic CVA about 30 days after the first dose of Moderna.  Patient received tPA but has some mild residual deficits (facial droop).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Eye movement disorder, Loss of consciousness, Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 11-year-old female patient. Concomitant therapies included MENACTRA and ADACEL. The patient had no pertinent medical history or drug reactions/ allergies.   On 29-MAR-2021 the patient was vaccinated with the first dose of GARDASIL 9 (lot # T026954, expiration date 13-APR-2022, 0.5 milliliter, once) via intramuscular for vaccination.   On 29-MAR-2021, the patient experienced seizure like tonic-clonic movement with syncope after receiving first dose of GARDASIL 9 along with MENACTRA and ADACEL. The patient recovered after 15 minutes (on 29-MAR-2021). The patient was given cool compress and maintained a supine position as treatment. No lab diagnostics/studies were performed. The patient had sought medical attention. The events were not cancer, and the patient was not overdose. Device was not available for evaluation (obtain was false).  The causality between GARDASIL 9 and the events was not reported.  Upon internal review, seizure like tonic-clonic movement with syncope were determined to be medically significant. Combination product report: Yes; Brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: T026954; expiration date: 13-APR-2022; device age and unit: 0 ; malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.