chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: developed an acute case of herpes zoster; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN1680), via an unspecified route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included pacemaker, blood pressure high and sulfa allergy. Concomitant medications included loratadine (CLARITIN), metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for unknown indications from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 09:00, two weeks after the COVID-19 vaccine injection, the patient developed an acute case of herpes zoster that required an urgent care visit and antiviral therapy. The patient was treated for herpes zoster with valacyclovir (VALTREX) for seven days. The event resulted in emergency room/department or urgent care. The clinical outcome of herpes zoster was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Muscle aches; Nausea; Chills; Tiredness; This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the arm left on 11Jan2021 at 10:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, adhd, chronic migraine and penicillin allergy. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN), norethisterone (NORA BE) and propranolol (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jan2021 at 17:00 the patient experienced muscle aches, nausea, chills and tiredness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle aches, nausea, chills and tiredness was resolved. No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disorientation, Dizziness, Feeling abnormal, Muscle twitching, Suicidal ideation
Clinical narrative: A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cognitive disorder, Language disorder, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive, Speech disorder
Clinical narrative: A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Rash
Clinical narrative: Bruising on arms and legs. Rash on feet legs and arms
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Contusion, Platelet count, Platelet count decreased, Rash
Clinical narrative: Bruising on arms and legs. Rash on feet legs and arms
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Contusion, Platelet count decreased, Rash, Thrombocytopenia
Clinical narrative: Bruising on arms and legs. Rash on feet legs and arms
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Per Alert, this patient's first dose/vaccine was Pfizer on 3/27 and the 2nd dose/vaccine was Moderna on 4/18, Alert says "NOT VALID" for the Moderna vaccine.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Per Alert, this patient's first dose/vaccine was Pfizer on 3/27 and the 2nd dose/vaccine was Moderna on 4/18, Alert says "NOT VALID" for the Moderna vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: All over body rash starting early the next morning, which continued for 7 days.  Rash was dark red, tightly clustered bumps over entire body.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: All over body rash starting early the next morning, which continued for 7 days.  Rash was dark red, tightly clustered bumps over entire body.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Injection site discomfort, Injection site paraesthesia, Nausea
Clinical narrative: Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needles sensation; Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paresthesia; Body racked with tremors; Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered in Arm Left on 30Apr2021 09:00 at the age of (48-years-old) as a single dose for covid-19 immunisation. Medical history included Hashimoto's hypothyroidism from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with covid. The patient was not tested positive for covid after post vaccination. The patient did not have any allergies. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. It was reported that after 5 min of vaccination patient left arm felt heavy and tingly throughout. 10 min later arms and legs, lips and tongue began tingling. Transferred to emergency room. Upon arrival body racked with tremors, dizziness, and nausea. Tremors lasted an hour and then subsided. Left side of face has sensation of paraesthesia still today (Tues night). On day 5 after vaccination new symptoms are experienced swollen and stiff fingers, aching joints, strong headache, waves of adrenaline rushes. Left side of face unchanged, still pain and needles sensation. The patient was recovered from Tremors. And not recovered from Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paraesthesia, Dizziness, Nausea, Aching joints, Swollen and stiff fingers, Swollen and stiff fingers, Strong headache, Pain and needles sensation.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Tremor
Clinical narrative: Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needles sensation; Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paresthesia; Body racked with tremors; Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered in Arm Left on 30Apr2021 09:00 at the age of (48-years-old) as a single dose for covid-19 immunisation. Medical history included Hashimoto's hypothyroidism from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with covid. The patient was not tested positive for covid after post vaccination. The patient did not have any allergies. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. It was reported that after 5 min of vaccination patient left arm felt heavy and tingly throughout. 10 min later arms and legs, lips and tongue began tingling. Transferred to emergency room. Upon arrival body racked with tremors, dizziness, and nausea. Tremors lasted an hour and then subsided. Left side of face has sensation of paraesthesia still today (Tues night). On day 5 after vaccination new symptoms are experienced swollen and stiff fingers, aching joints, strong headache, waves of adrenaline rushes. Left side of face unchanged, still pain and needles sensation. The patient was recovered from Tremors. And not recovered from Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paraesthesia, Dizziness, Nausea, Aching joints, Swollen and stiff fingers, Swollen and stiff fingers, Strong headache, Pain and needles sensation.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needles sensation; Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paresthesia; Body racked with tremors; Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered in Arm Left on 30Apr2021 09:00 at the age of (48-years-old) as a single dose for covid-19 immunisation. Medical history included Hashimoto's hypothyroidism from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with covid. The patient was not tested positive for covid after post vaccination. The patient did not have any allergies. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. It was reported that after 5 min of vaccination patient left arm felt heavy and tingly throughout. 10 min later arms and legs, lips and tongue began tingling. Transferred to emergency room. Upon arrival body racked with tremors, dizziness, and nausea. Tremors lasted an hour and then subsided. Left side of face has sensation of paraesthesia still today (Tues night). On day 5 after vaccination new symptoms are experienced swollen and stiff fingers, aching joints, strong headache, waves of adrenaline rushes. Left side of face unchanged, still pain and needles sensation. The patient was recovered from Tremors. And not recovered from Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paraesthesia, Dizziness, Nausea, Aching joints, Swollen and stiff fingers, Swollen and stiff fingers, Strong headache, Pain and needles sensation.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Peripheral swelling, Tremor
Clinical narrative: Aching joints; Swollen and stiff fingers; Swollen and stiff fingers; Strong headache; Pain and needles sensation; Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paresthesia; Body racked with tremors; Dizziness; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered in Arm Left on 30Apr2021 09:00 at the age of (48-years-old) as a single dose for covid-19 immunisation. Medical history included Hashimoto's hypothyroidism from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with covid. The patient was not tested positive for covid after post vaccination. The patient did not have any allergies. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported. It was reported that after 5 min of vaccination patient left arm felt heavy and tingly throughout. 10 min later arms and legs, lips and tongue began tingling. Transferred to emergency room. Upon arrival body racked with tremors, dizziness, and nausea. Tremors lasted an hour and then subsided. Left side of face has sensation of paraesthesia still today (Tues night). On day 5 after vaccination new symptoms are experienced swollen and stiff fingers, aching joints, strong headache, waves of adrenaline rushes. Left side of face unchanged, still pain and needles sensation. The patient was recovered from Tremors. And not recovered from Left arm felt heavy and tingly throughout/Arms and legs, lips and tongue began tingling, Left side of face has sensation of paraesthesia, Dizziness, Nausea, Aching joints, Swollen and stiff fingers, Swollen and stiff fingers, Strong headache, Pain and needles sensation.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oxygen saturation decreased, Throat tightness
Clinical narrative: difficulty swallowing,
Age: 45.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dysphagia
Clinical narrative: difficulty swallowing,
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: On April 16th 2021, my family and I all went to get Covid tested because I had nasal congestion and my husband was sicker. I thought I had allergies, but I did have lost of taste as well. My whole family tested positive for Covid, but I felt better within a week. My family has five people, for reference and we all tested positive.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, COVID-19, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: On April 16th 2021, my family and I all went to get Covid tested because I had nasal congestion and my husband was sicker. I thought I had allergies, but I did have lost of taste as well. My whole family tested positive for Covid, but I felt better within a week. My family has five people, for reference and we all tested positive.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: patient has had a daily, sometimes severe headache that started 1-2 days following 2nd Covid vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Limb discomfort, Nausea, Vomiting
Clinical narrative: patient has had a daily, sometimes severe headache that started 1-2 days following 2nd Covid vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, New daily persistent headache
Clinical narrative: patient has had a daily, sometimes severe headache that started 1-2 days following 2nd Covid vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle tightness
Clinical narrative: fter 20 minutes in the observation area on 5/15/2021, client reported numbness and tingling in both feet that progressed to the thighs. Client reported she was observed for 2 hours by vaccination staff. Mobility was unaffected and no intervention medications administered on-site. Client reported she went home and numbness and tingling resolved after 2 more hours. Client reported she woke up the next day with headache and chills, which she treated with a single dose of Tylenol. Headache and chills resolved over 3 days.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: fter 20 minutes in the observation area on 5/15/2021, client reported numbness and tingling in both feet that progressed to the thighs. Client reported she was observed for 2 hours by vaccination staff. Mobility was unaffected and no intervention medications administered on-site. Client reported she went home and numbness and tingling resolved after 2 more hours. Client reported she woke up the next day with headache and chills, which she treated with a single dose of Tylenol. Headache and chills resolved over 3 days.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error.  "COVID Vaccine Event" advertised for ages 16+.  Staff checked ID, verified DOB, and administered Moderna vaccine, which is not FDA approved for under 18 years old.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Confusional state
Clinical narrative: Patient was a healthy 46 y/o male with no significant medical history.  He was taking no medications.  He received the J&J vaccine on 04/06/2021.  On 04/28/2021 he had a fall from probable syncope.  He sustained a laceration to his forehead.  He was sent to Hospital for evaluation.  He had CTs of head and neck, which were unremarkable.  A drug screen was negative.  Both before and after his return he was having issues with his speech.  He seemed to understand words but when he tried to respond, his speech was garbled .  He was observed in the infirmary.  There was slight improvement in speech.  He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021.  This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct.  While an outpatient workup was being scheduled, he had another episode of witnessed syncope.  This was on 06/14/2021.  An MRI at hospital showed a larger infarct than seen on 06/03/2021.  He was hospitalized for 3 days.  No cause for the CVA was found during this hospitalization.  He has continued with speech symptoms and is starting speech therapy in the near future.  In summary, this I/M was in a normal state of health with no risk factors for vascular disease.  Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021.  After multiple tests, no reason was found for the CVA to occur.  It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Fall, Head injury, Headache, Loss of consciousness
Clinical narrative: Patient was a healthy 46 y/o male with no significant medical history.  He was taking no medications.  He received the J&J vaccine on 04/06/2021.  On 04/28/2021 he had a fall from probable syncope.  He sustained a laceration to his forehead.  He was sent to Hospital for evaluation.  He had CTs of head and neck, which were unremarkable.  A drug screen was negative.  Both before and after his return he was having issues with his speech.  He seemed to understand words but when he tried to respond, his speech was garbled .  He was observed in the infirmary.  There was slight improvement in speech.  He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021.  This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct.  While an outpatient workup was being scheduled, he had another episode of witnessed syncope.  This was on 06/14/2021.  An MRI at hospital showed a larger infarct than seen on 06/03/2021.  He was hospitalized for 3 days.  No cause for the CVA was found during this hospitalization.  He has continued with speech symptoms and is starting speech therapy in the near future.  In summary, this I/M was in a normal state of health with no risk factors for vascular disease.  Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021.  After multiple tests, no reason was found for the CVA to occur.  It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Syncope
Clinical narrative: Patient was a healthy 46 y/o male with no significant medical history.  He was taking no medications.  He received the J&J vaccine on 04/06/2021.  On 04/28/2021 he had a fall from probable syncope.  He sustained a laceration to his forehead.  He was sent to Hospital for evaluation.  He had CTs of head and neck, which were unremarkable.  A drug screen was negative.  Both before and after his return he was having issues with his speech.  He seemed to understand words but when he tried to respond, his speech was garbled .  He was observed in the infirmary.  There was slight improvement in speech.  He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021.  This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct.  While an outpatient workup was being scheduled, he had another episode of witnessed syncope.  This was on 06/14/2021.  An MRI at hospital showed a larger infarct than seen on 06/03/2021.  He was hospitalized for 3 days.  No cause for the CVA was found during this hospitalization.  He has continued with speech symptoms and is starting speech therapy in the near future.  In summary, this I/M was in a normal state of health with no risk factors for vascular disease.  Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021.  After multiple tests, no reason was found for the CVA to occur.  It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral infarction, Cerebrovascular accident, Computerised tomogram head normal, Computerised tomogram neck, Drug screen negative
Clinical narrative: Patient was a healthy 46 y/o male with no significant medical history.  He was taking no medications.  He received the J&J vaccine on 04/06/2021.  On 04/28/2021 he had a fall from probable syncope.  He sustained a laceration to his forehead.  He was sent to Hospital for evaluation.  He had CTs of head and neck, which were unremarkable.  A drug screen was negative.  Both before and after his return he was having issues with his speech.  He seemed to understand words but when he tried to respond, his speech was garbled .  He was observed in the infirmary.  There was slight improvement in speech.  He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021.  This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct.  While an outpatient workup was being scheduled, he had another episode of witnessed syncope.  This was on 06/14/2021.  An MRI at hospital showed a larger infarct than seen on 06/03/2021.  He was hospitalized for 3 days.  No cause for the CVA was found during this hospitalization.  He has continued with speech symptoms and is starting speech therapy in the near future.  In summary, this I/M was in a normal state of health with no risk factors for vascular disease.  Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021.  After multiple tests, no reason was found for the CVA to occur.  It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Fall, Laboratory test, Magnetic resonance imaging head abnormal, Skin laceration
Clinical narrative: Patient was a healthy 46 y/o male with no significant medical history.  He was taking no medications.  He received the J&J vaccine on 04/06/2021.  On 04/28/2021 he had a fall from probable syncope.  He sustained a laceration to his forehead.  He was sent to Hospital for evaluation.  He had CTs of head and neck, which were unremarkable.  A drug screen was negative.  Both before and after his return he was having issues with his speech.  He seemed to understand words but when he tried to respond, his speech was garbled .  He was observed in the infirmary.  There was slight improvement in speech.  He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021.  This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct.  While an outpatient workup was being scheduled, he had another episode of witnessed syncope.  This was on 06/14/2021.  An MRI at hospital showed a larger infarct than seen on 06/03/2021.  He was hospitalized for 3 days.  No cause for the CVA was found during this hospitalization.  He has continued with speech symptoms and is starting speech therapy in the near future.  In summary, this I/M was in a normal state of health with no risk factors for vascular disease.  Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021.  After multiple tests, no reason was found for the CVA to occur.  It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Syncope
Clinical narrative: Patient was a healthy 46 y/o male with no significant medical history.  He was taking no medications.  He received the J&J vaccine on 04/06/2021.  On 04/28/2021 he had a fall from probable syncope.  He sustained a laceration to his forehead.  He was sent to Hospital for evaluation.  He had CTs of head and neck, which were unremarkable.  A drug screen was negative.  Both before and after his return he was having issues with his speech.  He seemed to understand words but when he tried to respond, his speech was garbled .  He was observed in the infirmary.  There was slight improvement in speech.  He returned to his block. Because of persistent issues with speech he had an MRI of his brain on 06/03/2021.  This showed a left middle cerebral infarct which appeared as a late subacute/early chronic infarct.  While an outpatient workup was being scheduled, he had another episode of witnessed syncope.  This was on 06/14/2021.  An MRI at hospital showed a larger infarct than seen on 06/03/2021.  He was hospitalized for 3 days.  No cause for the CVA was found during this hospitalization.  He has continued with speech symptoms and is starting speech therapy in the near future.  In summary, this I/M was in a normal state of health with no risk factors for vascular disease.  Two weeks after receiving the J&J vaccine, he had a CVA which may have extended on 06/14/2021.  After multiple tests, no reason was found for the CVA to occur.  It is certainly possible that the CVA was related to his COVID-19 J&J vaccine.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: AFFECTING MOVEMENT IN ELBOW AND SHOULDER OF INJECTION ARM; UNABLE TO STRAIGHTEN ELBOW WITHOUT BEING IN PAIN; HAVING PAIN IN THE INJECTION ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced affecting movement in elbow and shoulder of injection arm, unable to straighten elbow without being in pain, and having pain in the injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having pain in the injection arm, unable to straighten elbow without being in pain, and affecting movement in elbow and shoulder of injection arm. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased
Clinical narrative: AFFECTING MOVEMENT IN ELBOW AND SHOULDER OF INJECTION ARM; UNABLE TO STRAIGHTEN ELBOW WITHOUT BEING IN PAIN; HAVING PAIN IN THE INJECTION ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced affecting movement in elbow and shoulder of injection arm, unable to straighten elbow without being in pain, and having pain in the injection arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having pain in the injection arm, unable to straighten elbow without being in pain, and affecting movement in elbow and shoulder of injection arm. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Inflammation
Clinical narrative: HEMATOMA  CHEST ESTOMAC  ANCHOR AREA FEET LEG INFLAMATION BOOT
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest wall haematoma, Inflammation, Peripheral swelling
Clinical narrative: HEMATOMA  CHEST ESTOMAC  ANCHOR AREA FEET LEG INFLAMATION BOOT
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain
Clinical narrative: He was administered the vaccine in his left shoulder and there was some pain and erythema.  Mom puts some hydrocortisone cream on the shoulder.  Within 3 days, the patient was admitted to the hospital for chest pain and elevated troponin.  Vaccine was administered 06/29/2021 and the patient started developing chest pain around midnight/1:00 a.m. on 07/02/2021.  He was up that night playing video games with his friends but went to bed at 10:00 a.m..  He started having some discomfort at midnight and was up to 4:00 a.m. on 07/02/2021.  He came to the parent's bedroom and said his chest hurt.  They called the pediatrician who told them to go to emergency room.  Troponin-I was elevated up to 170ng/L (normal less than 45).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Discomfort, Echocardiogram normal, Ejection fraction normal, Electrocardiogram ST segment elevation
Clinical narrative: He was administered the vaccine in his left shoulder and there was some pain and erythema.  Mom puts some hydrocortisone cream on the shoulder.  Within 3 days, the patient was admitted to the hospital for chest pain and elevated troponin.  Vaccine was administered 06/29/2021 and the patient started developing chest pain around midnight/1:00 a.m. on 07/02/2021.  He was up that night playing video games with his friends but went to bed at 10:00 a.m..  He started having some discomfort at midnight and was up to 4:00 a.m. on 07/02/2021.  He came to the parent's bedroom and said his chest hurt.  They called the pediatrician who told them to go to emergency room.  Troponin-I was elevated up to 170ng/L (normal less than 45).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram repolarisation abnormality, Injection site erythema, Injection site pain, Troponin I increased
Clinical narrative: He was administered the vaccine in his left shoulder and there was some pain and erythema.  Mom puts some hydrocortisone cream on the shoulder.  Within 3 days, the patient was admitted to the hospital for chest pain and elevated troponin.  Vaccine was administered 06/29/2021 and the patient started developing chest pain around midnight/1:00 a.m. on 07/02/2021.  He was up that night playing video games with his friends but went to bed at 10:00 a.m..  He started having some discomfort at midnight and was up to 4:00 a.m. on 07/02/2021.  He came to the parent's bedroom and said his chest hurt.  They called the pediatrician who told them to go to emergency room.  Troponin-I was elevated up to 170ng/L (normal less than 45).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chest X-ray normal, Chest pain, Echocardiogram normal, Palpitations
Clinical narrative: He was administered the vaccine in his left shoulder and there was some pain and erythema.  Mom puts some hydrocortisone cream on the shoulder.  Within 3 days, the patient was admitted to the hospital for chest pain and elevated troponin.  Vaccine was administered 06/29/2021 and the patient started developing chest pain around midnight/1:00 a.m. on 07/02/2021.  He was up that night playing video games with his friends but went to bed at 10:00 a.m..  He started having some discomfort at midnight and was up to 4:00 a.m. on 07/02/2021.  He came to the parent's bedroom and said his chest hurt.  They called the pediatrician who told them to go to emergency room.  Troponin-I was elevated up to 170ng/L (normal less than 45).
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Troponin increased
Clinical narrative: He was administered the vaccine in his left shoulder and there was some pain and erythema.  Mom puts some hydrocortisone cream on the shoulder.  Within 3 days, the patient was admitted to the hospital for chest pain and elevated troponin.  Vaccine was administered 06/29/2021 and the patient started developing chest pain around midnight/1:00 a.m. on 07/02/2021.  He was up that night playing video games with his friends but went to bed at 10:00 a.m..  He started having some discomfort at midnight and was up to 4:00 a.m. on 07/02/2021.  He came to the parent's bedroom and said his chest hurt.  They called the pediatrician who told them to go to emergency room.  Troponin-I was elevated up to 170ng/L (normal less than 45).
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: about 24 hours after second shot a lymph node appeared on neck. Location is on the left side of body, same side as the shot that took; This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient received bnt162b2 (BNT162B2, Pfizer) at the age of 32-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 02Jul2021 12:00 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, no known allergies. The COVID-19 vaccine was administered in Other (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. There were no concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19. Historical Vaccine included BNT162B2 for COVID-19 Immunization on 11Jun2021 at the age of 32-year-old (1st dose, Product: COVID 19, brand: Pfizer, Lot number: EW0196, Administration time: 12:00 PM, Vaccine location: Left arm). Adverse event: about 24 hours after second shot a lymph node appeared on neck. Location is on the left side of body, same side as the shot that took since 03Jul2021 07:15 PM. No treatment was received. The event outcome was not recovered. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: platelet level at 9; fever up to 105F; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received the second dose of bnt162b2 (BNT162B, Solution for injection, Lot Number: EW01872), via an unspecified route of administration, administered in Arm Left on 16Jun2021 (at the age of 15-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient had no relevant medical history or concomitant medications to report. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not pregnant at the time of vaccination and adverse events. The patient previously received the first dose of bnt162b2 (BNT162B, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 26May2021 (at the age of 15-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. On 21Jun2021, the patient had fever up to 105F the day after 2nd dose of vaccine, which was managed and went away. She was scheduled for annual physical on 21Jun2021 and the doctor (withheld) ran a routine blood work. The resullts came back with platelet level at 9. the test was repeated the next day (22Jun2021) a few times, but the results came with numbers ranging at 6-7. She was admitted to (hospital name withheld) where she received steroid and IVig  infusion. The adverse events resulted into Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. Outcome of the event platelet level at 9 was not recovered, while fever up to 105F recovered on an unspecified date.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Platelet count, Platelet count decreased, Pyrexia
Clinical narrative: platelet level at 9; fever up to 105F; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received the second dose of bnt162b2 (BNT162B, Solution for injection, Lot Number: EW01872), via an unspecified route of administration, administered in Arm Left on 16Jun2021 (at the age of 15-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient had no relevant medical history or concomitant medications to report. There were no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient was not pregnant at the time of vaccination and adverse events. The patient previously received the first dose of bnt162b2 (BNT162B, Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 26May2021 (at the age of 15-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. On 21Jun2021, the patient had fever up to 105F the day after 2nd dose of vaccine, which was managed and went away. She was scheduled for annual physical on 21Jun2021 and the doctor (withheld) ran a routine blood work. The resullts came back with platelet level at 9. the test was repeated the next day (22Jun2021) a few times, but the results came with numbers ranging at 6-7. She was admitted to (hospital name withheld) where she received steroid and IVig  infusion. The adverse events resulted into Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. Outcome of the event platelet level at 9 was not recovered, while fever up to 105F recovered on an unspecified date.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Condition aggravated, Differential white blood cell count, Full blood count, Magnetic resonance imaging
Clinical narrative: loud, pulsating ringing in my ears/mild tinnitus/pulsatile tinnitus; pulsatile tinnitus; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number: EW0175), via an unspecified route of administration on the left arm, on 06May2021(Age at Vaccination: 64 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history was mild heart murmur and had no allergies. Device time stamp was 08Jul201. Prior vaccination the patient had no covid.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number: Unknown), via an unspecified route of administration in the left arm on 15Apr2021, as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medications in two weeks included colecalciferol, dicalcium malate, durapatite, genistein, menaquinone-7, sodium phosphate dibasic, zinc bis glycinate chelate (FOSTEUM PLUS), Ergocalciferol (VIT D) and probiotics taken for unspecified indication form an unknown date. The patient had no known allergies. On 22May2021 04:00 AM, the patient woke at 04:00 AM with loud, pulsating ringing in my ears. She has since been diagnosed with pulsatile tinnitus and it was not improved. She stated that she had very mild tinnitus in the past, but nothing like this. The patient was afraid to get on an airplane because she was fear the pressure will make it worse. She would like to know if there is any way to reverse the problem.The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not received any other vaccines within four weeks. Post vaccination the patient had not tested for covid. Therapeutic measures were taken and the patient received Medrol steroid as a treatment but had no effect. The outcome of the event was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: loud, pulsating ringing in my ears/mild tinnitus/pulsatile tinnitus; pulsatile tinnitus; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number: EW0175), via an unspecified route of administration on the left arm, on 06May2021(Age at Vaccination: 64 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history was mild heart murmur and had no allergies. Device time stamp was 08Jul201. Prior vaccination the patient had no covid.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number: Unknown), via an unspecified route of administration in the left arm on 15Apr2021, as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medications in two weeks included colecalciferol, dicalcium malate, durapatite, genistein, menaquinone-7, sodium phosphate dibasic, zinc bis glycinate chelate (FOSTEUM PLUS), Ergocalciferol (VIT D) and probiotics taken for unspecified indication form an unknown date. The patient had no known allergies. On 22May2021 04:00 AM, the patient woke at 04:00 AM with loud, pulsating ringing in my ears. She has since been diagnosed with pulsatile tinnitus and it was not improved. She stated that she had very mild tinnitus in the past, but nothing like this. The patient was afraid to get on an airplane because she was fear the pressure will make it worse. She would like to know if there is any way to reverse the problem.The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not received any other vaccines within four weeks. Post vaccination the patient had not tested for covid. Therapeutic measures were taken and the patient received Medrol steroid as a treatment but had no effect. The outcome of the event was not recovered.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: allergic reaction to one of the ingredients in the Shingrix vaccine; rash / on the backs of both hands and both wrists; blisters on the backs of both hands and both wrists; chills; slight fever; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021 10:00, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2021, 12 hrs after receiving Shingrix, the patient experienced chills, fever and muscle pain. On 8th July 2021, the patient experienced rash and blister. On an unknown date, the patient experienced allergic reaction to drug excipient. On 8th July 2021, the outcome of the chills, fever and muscle pain were recovered/resolved. On an unknown date, the outcome of the rash, blister and allergic reaction to drug excipient were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, muscle pain, rash, blister and allergic reaction to drug excipient to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient had taken first dose of Shingrix in her left arm at 10 am and experienced chills, slight fever, muscle aches approximately 12 hours after vaccination. The reporter stated that, day after patient received the Shigles vaccine and day after developed a rash and blisters on the backs of both hands and both wrists and it might be an allergic reaction to one of the ingredients in the Shingrix vaccine. On 13th July 2021 the rash and blisters are not resolved and some blister look worse. The HCP (Heath care professional), had prednisone Rx to the patient but she was unsure as whether to take it for fear of messing with the Shingrix vaccine. The reporter did not consented to follow up. The reporter does not give permission to contact HCP.