chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Investigation, Pain in extremity
Clinical narrative: had swollen and red arm located just above the right elbow/lower part of his arm, including his hand, is swollen and very dark red; had swollen and red arm located just above the right elbow/lower part of his arm, including his hand, is swollen and very dark red; This is a spontaneous report received from contactable reporter (other HCP) from medical information team.  A 81 year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "defibrillator" (unspecified if ongoing); "stroke" (unspecified if ongoing), notes: patient has recuperated; "medical problems" (unspecified if ongoing), notes: but he is fine, walks every day and active. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Lot number: EL9262), for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 03Mar2021, outcome "not recovered" and all described as "had swollen and red arm located just above the right elbow/lower part of his arm, including his hand, is swollen and very dark red". The event "had swollen and red arm located just above the right elbow/lower part of his arm, including his hand, is swollen and very dark red" and "had swollen and red arm located just above the right elbow/lower part of his arm, including his hand, is swollen and very dark red" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema. Additional information: The patient received 1 pill of Zyrtec as treatment for the event but did not do anything as reported.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Swelling face
Clinical narrative: Facial and neck swelling for 45 min after first dose.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Facial and neck swelling for 45 min after first dose.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Anxiety, Asthenia, Body temperature, Chills
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Feeling hot, Heart rate increased, Hunger
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Malaise, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Paraesthesia, Pyrexia, Respiratory alkalosis, Somnolence
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Urinary tract infection, X-ray
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Dyspnoea, Electrocardiogram normal, Laboratory test normal, Muscle spasms
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 0.08
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Paraesthesia, Pyrexia, X-ray normal
Clinical narrative: I had my 1st dose of Pfizer vaccine on 6/8/2021, after that, I developed a fever. I took Tylenol for my fever. On day four, 6/11/2021. I had a panic attack and severe shortness of breath. My body tingle, my arms and hand cramped. I called the ambulance. Medic said it was a panic attack. I had never had a panic attack before in my lifetime. After that, I went to urgent care and was prescribed Hydroxyzine HCI 50mg for my breathing, it didn't really help. My doctor gave me Alprazolam 0.25mg. On 6/14, 6/16, 9/19, and 6/21. I had severe shortness of breath. I went to ER four times. ER did blood work, EKG, x-ray, etc. They did not find anything.  Continue on page 3. Your page 2 is not editable.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Swelling of left wrist and hand; Swelling of left wrist and hand; Pain; Change in sensation in hand; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jul2021 at 13:30 (Lot number: EW0186) at the age of 15 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Immunoglobulin G low" (unspecified if ongoing), notes: Low IgG; "Mitral regurgitation" (unspecified if ongoing), notes: Mild mitral valve regurgitation and "Pulmonic stenosis" (unspecified if ongoing), notes: Mild peripheral pulmonic stenosis. Concomitant medication(s) included: HYDROCORTISONE CREAM and ALLEGRA. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EWO186, Anatomical site: left arm, Administration time: 13:30), administration date: 16Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: JOINT SWELLING (non-serious), with onset 07Jul2021 at 14:00, outcome "not recovered", described as "Swelling of left wrist and hand", PERIPHERAL SWELLING (non-serious), with onset 07Jul2021 at 14:00, outcome "not recovered", described as "Swelling of left wrist and hand", PAIN (non-serious) with onset 07Jul2021 at 14:00, outcome "not recovered", described as ''Pain'', SENSORY DISTURBANCE (non-serious) with onset 07Jul2021 at 14:00, outcome "not recovered", described as "Change in sensation in hand". The events "Swelling of left wrist and hand, Pain and Change in sensation in hand'' were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint swelling, peripheral swelling, pain and sensory disturbance.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient received the treatment of 9 day course of steroids
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Pain, Peripheral swelling, SARS-CoV-2 test, Sensory disturbance
Clinical narrative: Swelling of left wrist and hand; Swelling of left wrist and hand; Pain; Change in sensation in hand; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jul2021 at 13:30 (Lot number: EW0186) at the age of 15 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Immunoglobulin G low" (unspecified if ongoing), notes: Low IgG; "Mitral regurgitation" (unspecified if ongoing), notes: Mild mitral valve regurgitation and "Pulmonic stenosis" (unspecified if ongoing), notes: Mild peripheral pulmonic stenosis. Concomitant medication(s) included: HYDROCORTISONE CREAM and ALLEGRA. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EWO186, Anatomical site: left arm, Administration time: 13:30), administration date: 16Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: JOINT SWELLING (non-serious), with onset 07Jul2021 at 14:00, outcome "not recovered", described as "Swelling of left wrist and hand", PERIPHERAL SWELLING (non-serious), with onset 07Jul2021 at 14:00, outcome "not recovered", described as "Swelling of left wrist and hand", PAIN (non-serious) with onset 07Jul2021 at 14:00, outcome "not recovered", described as ''Pain'', SENSORY DISTURBANCE (non-serious) with onset 07Jul2021 at 14:00, outcome "not recovered", described as "Change in sensation in hand". The events "Swelling of left wrist and hand, Pain and Change in sensation in hand'' were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint swelling, peripheral swelling, pain and sensory disturbance.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. The patient received the treatment of 9 day course of steroids
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Headache, Joint swelling, Pyrexia
Clinical narrative: 1/29/21 - 3:00PM - Dizzy, rapid  heart rate / 11:30 PM - Extreme muscle pain on total left side of body (side of injection) 1/29/21 - 2/8/21 - Severe headache 1/30/21 - 2/2/21 - Fever 1/31/21 - Present (10 months) - severe joint pain mainly on left side. Knee and ankle pain so severe that it is difficult to walk.  Ankle joints have not been able to hold weight resulting in falls.  Other joints on both sides frequently swell and are painful to use.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: 1/29/21 - 3:00PM - Dizzy, rapid  heart rate / 11:30 PM - Extreme muscle pain on total left side of body (side of injection) 1/29/21 - 2/8/21 - Severe headache 1/30/21 - 2/2/21 - Fever 1/31/21 - Present (10 months) - severe joint pain mainly on left side. Knee and ankle pain so severe that it is difficult to walk.  Ankle joints have not been able to hold weight resulting in falls.  Other joints on both sides frequently swell and are painful to use.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fall, Gait disturbance, Headache
Clinical narrative: 1/29/21 - 3:00PM - Dizzy, rapid  heart rate / 11:30 PM - Extreme muscle pain on total left side of body (side of injection) 1/29/21 - 2/8/21 - Severe headache 1/30/21 - 2/2/21 - Fever 1/31/21 - Present (10 months) - severe joint pain mainly on left side. Knee and ankle pain so severe that it is difficult to walk.  Ankle joints have not been able to hold weight resulting in falls.  Other joints on both sides frequently swell and are painful to use.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Joint swelling, Myalgia, Pain, Pyrexia
Clinical narrative: 1/29/21 - 3:00PM - Dizzy, rapid  heart rate / 11:30 PM - Extreme muscle pain on total left side of body (side of injection) 1/29/21 - 2/8/21 - Severe headache 1/30/21 - 2/2/21 - Fever 1/31/21 - Present (10 months) - severe joint pain mainly on left side. Knee and ankle pain so severe that it is difficult to walk.  Ankle joints have not been able to hold weight resulting in falls.  Other joints on both sides frequently swell and are painful to use.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight bearing difficulty
Clinical narrative: 1/29/21 - 3:00PM - Dizzy, rapid  heart rate / 11:30 PM - Extreme muscle pain on total left side of body (side of injection) 1/29/21 - 2/8/21 - Severe headache 1/30/21 - 2/2/21 - Fever 1/31/21 - Present (10 months) - severe joint pain mainly on left side. Knee and ankle pain so severe that it is difficult to walk.  Ankle joints have not been able to hold weight resulting in falls.  Other joints on both sides frequently swell and are painful to use.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Headache, Pain, Pain in extremity
Clinical narrative: Was diagnosed with a subluxation of the cervical spine; neck pain/neck pain worsened; neck pain/neck pain worsened; even stronger side-effects with nausea and dizziness; even stronger side-effects with nausea and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 18Sep2021 15:00 (Lot number: FF8839) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 28Aug2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Full body aches", "Muscle pain/tension/tightness", "Muscle pain/tension/tightness", "muscle pain/tension/tightness", "Neck pain", "Metallic taste in mouth not long after receiving the vaccine", "I was also extremely thirsty even though I did drink extra water", "Tiredness", "Weakness". The following information was reported: DISLOCATION OF VERTEBRA (medically significant) with onset Sep2021, outcome "not recovered", described as "Was diagnosed with a subluxation of the cervical spine"; NECK PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "neck pain/neck pain worsened"; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "even stronger side-effects with nausea and dizziness". The events "was diagnosed with a subluxation of the cervical spine", "neck pain/neck pain worsened", "neck pain/neck pain worsened", "even stronger side-effects with nausea and dizziness" and "even stronger side-effects with nausea and dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dislocation of vertebra, neck pain, condition aggravated, nausea, dizziness.  Additional information: patient did not receive any vaccine within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19. seeing doctor for neck/back adjustments. She did not receive any other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thirst
Clinical narrative: Was diagnosed with a subluxation of the cervical spine; neck pain/neck pain worsened; neck pain/neck pain worsened; even stronger side-effects with nausea and dizziness; even stronger side-effects with nausea and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 18Sep2021 15:00 (Lot number: FF8839) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 28Aug2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Full body aches", "Muscle pain/tension/tightness", "Muscle pain/tension/tightness", "muscle pain/tension/tightness", "Neck pain", "Metallic taste in mouth not long after receiving the vaccine", "I was also extremely thirsty even though I did drink extra water", "Tiredness", "Weakness". The following information was reported: DISLOCATION OF VERTEBRA (medically significant) with onset Sep2021, outcome "not recovered", described as "Was diagnosed with a subluxation of the cervical spine"; NECK PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "neck pain/neck pain worsened"; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "even stronger side-effects with nausea and dizziness". The events "was diagnosed with a subluxation of the cervical spine", "neck pain/neck pain worsened", "neck pain/neck pain worsened", "even stronger side-effects with nausea and dizziness" and "even stronger side-effects with nausea and dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dislocation of vertebra, neck pain, condition aggravated, nausea, dizziness.  Additional information: patient did not receive any vaccine within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19. seeing doctor for neck/back adjustments. She did not receive any other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dislocation of vertebra, Dizziness, Nausea, Neck pain
Clinical narrative: Was diagnosed with a subluxation of the cervical spine; neck pain/neck pain worsened; neck pain/neck pain worsened; even stronger side-effects with nausea and dizziness; even stronger side-effects with nausea and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 18Sep2021 15:00 (Lot number: FF8839) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 28Aug2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Full body aches", "Muscle pain/tension/tightness", "Muscle pain/tension/tightness", "muscle pain/tension/tightness", "Neck pain", "Metallic taste in mouth not long after receiving the vaccine", "I was also extremely thirsty even though I did drink extra water", "Tiredness", "Weakness". The following information was reported: DISLOCATION OF VERTEBRA (medically significant) with onset Sep2021, outcome "not recovered", described as "Was diagnosed with a subluxation of the cervical spine"; NECK PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "neck pain/neck pain worsened"; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "even stronger side-effects with nausea and dizziness". The events "was diagnosed with a subluxation of the cervical spine", "neck pain/neck pain worsened", "neck pain/neck pain worsened", "even stronger side-effects with nausea and dizziness" and "even stronger side-effects with nausea and dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dislocation of vertebra, neck pain, condition aggravated, nausea, dizziness.  Additional information: patient did not receive any vaccine within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19. seeing doctor for neck/back adjustments. She did not receive any other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Dysgeusia, Fatigue, Injury, Muscle tightness
Clinical narrative: Was diagnosed with a subluxation of the cervical spine; neck pain/neck pain worsened; neck pain/neck pain worsened; even stronger side-effects with nausea and dizziness; even stronger side-effects with nausea and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 18Sep2021 15:00 (Lot number: FF8839) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 28Aug2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Full body aches", "Muscle pain/tension/tightness", "Muscle pain/tension/tightness", "muscle pain/tension/tightness", "Neck pain", "Metallic taste in mouth not long after receiving the vaccine", "I was also extremely thirsty even though I did drink extra water", "Tiredness", "Weakness". The following information was reported: DISLOCATION OF VERTEBRA (medically significant) with onset Sep2021, outcome "not recovered", described as "Was diagnosed with a subluxation of the cervical spine"; NECK PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "neck pain/neck pain worsened"; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "even stronger side-effects with nausea and dizziness". The events "was diagnosed with a subluxation of the cervical spine", "neck pain/neck pain worsened", "neck pain/neck pain worsened", "even stronger side-effects with nausea and dizziness" and "even stronger side-effects with nausea and dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dislocation of vertebra, neck pain, condition aggravated, nausea, dizziness.  Additional information: patient did not receive any vaccine within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19. seeing doctor for neck/back adjustments. She did not receive any other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Neck pain, Pain, Thirst
Clinical narrative: Was diagnosed with a subluxation of the cervical spine; neck pain/neck pain worsened; neck pain/neck pain worsened; even stronger side-effects with nausea and dizziness; even stronger side-effects with nausea and dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 18Sep2021 15:00 (Lot number: FF8839) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing), notes: known allergies: Sulfa; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2588, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 28Aug2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "Full body aches", "Muscle pain/tension/tightness", "Muscle pain/tension/tightness", "muscle pain/tension/tightness", "Neck pain", "Metallic taste in mouth not long after receiving the vaccine", "I was also extremely thirsty even though I did drink extra water", "Tiredness", "Weakness". The following information was reported: DISLOCATION OF VERTEBRA (medically significant) with onset Sep2021, outcome "not recovered", described as "Was diagnosed with a subluxation of the cervical spine"; NECK PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "neck pain/neck pain worsened"; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "even stronger side-effects with nausea and dizziness". The events "was diagnosed with a subluxation of the cervical spine", "neck pain/neck pain worsened", "neck pain/neck pain worsened", "even stronger side-effects with nausea and dizziness" and "even stronger side-effects with nausea and dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dislocation of vertebra, neck pain, condition aggravated, nausea, dizziness.  Additional information: patient did not receive any vaccine within 4 weeks prior to the COVID vaccine and has not been tested for COVID-19. seeing doctor for neck/back adjustments. She did not receive any other medications the patient received within 2 weeks of vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Tremendous pain around heart, lungs and ribs became unbearable and it was a suspected myocarditis. 911 was called, hospitalized. Doctors admitted me in COVID-19 ward due to possible infection. For four days , Morfin injections were given. Later they were stopped as diastolic blood pressure remained 120 . Analysis results indicated asymptotic pneumonia. Advised rest for two months and Pulmonoligist feel it may take six months to recover. Next CT scan is scheduled in January 2022..I lost my job. I spent heavily due to hospitalization .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Inflammation, Insomnia, Investigation, Movement disorder
Clinical narrative: Tremendous pain around heart, lungs and ribs became unbearable and it was a suspected myocarditis. 911 was called, hospitalized. Doctors admitted me in COVID-19 ward due to possible infection. For four days , Morfin injections were given. Later they were stopped as diastolic blood pressure remained 120 . Analysis results indicated asymptotic pneumonia. Advised rest for two months and Pulmonoligist feel it may take six months to recover. Next CT scan is scheduled in January 2022..I lost my job. I spent heavily due to hospitalization .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Pneumonia bacterial, Pulmonary oedema, Pulmonary pain
Clinical narrative: Tremendous pain around heart, lungs and ribs became unbearable and it was a suspected myocarditis. 911 was called, hospitalized. Doctors admitted me in COVID-19 ward due to possible infection. For four days , Morfin injections were given. Later they were stopped as diastolic blood pressure remained 120 . Analysis results indicated asymptotic pneumonia. Advised rest for two months and Pulmonoligist feel it may take six months to recover. Next CT scan is scheduled in January 2022..I lost my job. I spent heavily due to hospitalization .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Aspiration pleural cavity, Blood pressure diastolic abnormal, Computerised tomogram, Inflammation
Clinical narrative: Tremendous pain around heart, lungs and ribs became unbearable and it was a suspected myocarditis. 911 was called, hospitalized. Doctors admitted me in COVID-19 ward due to possible infection. For four days , Morfin injections were given. Later they were stopped as diastolic blood pressure remained 120 . Analysis results indicated asymptotic pneumonia. Advised rest for two months and Pulmonoligist feel it may take six months to recover. Next CT scan is scheduled in January 2022..I lost my job. I spent heavily due to hospitalization .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test abnormal, Loss of employment, Musculoskeletal chest pain, Myocarditis, Pneumonia bacterial
Clinical narrative: Tremendous pain around heart, lungs and ribs became unbearable and it was a suspected myocarditis. 911 was called, hospitalized. Doctors admitted me in COVID-19 ward due to possible infection. For four days , Morfin injections were given. Later they were stopped as diastolic blood pressure remained 120 . Analysis results indicated asymptotic pneumonia. Advised rest for two months and Pulmonoligist feel it may take six months to recover. Next CT scan is scheduled in January 2022..I lost my job. I spent heavily due to hospitalization .
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonitis, Pulmonary pain, Suspected COVID-19, X-ray
Clinical narrative: Tremendous pain around heart, lungs and ribs became unbearable and it was a suspected myocarditis. 911 was called, hospitalized. Doctors admitted me in COVID-19 ward due to possible infection. For four days , Morfin injections were given. Later they were stopped as diastolic blood pressure remained 120 . Analysis results indicated asymptotic pneumonia. Advised rest for two months and Pulmonoligist feel it may take six months to recover. Next CT scan is scheduled in January 2022..I lost my job. I spent heavily due to hospitalization .
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Abnormal uterine bleeding, Condition aggravated, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 54 year old female. The patient's height was not reported, but stated as to be a small woman and weight was about 80-90 pounds. The patient's concurrent conditions included: cervicogenic headache for 26 years, complex chronic pain, occasional alcohol use, gluten intolerance, red wine allergy, seasonal allergies and non smoker. The patient has no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with gabapentin, epinephrine/procaine hydrochloride, nortriptyline hydrochloride, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: UNKNOWN), 1 total, dose was not reported, administered to left arm on 21-SEP-2021 10:45 for prophylactic vaccination. Dose series was 1. No concomitant medications were reported. On 21-SEP-2021, around 4-5 PM she started experiencing a severe headache, her heart was beating weird, blurry vision, muscle tightness and aches all over her body (not just on the injection site). After vaccination, her headache got extremely bad and she thought that she was going to die and needed to go to emergency room. She reported her heart palpitation lasted for hours and hours. The adverse effects lasted for a few days. Some symptoms have calmed down but the headache has gotten worse and worse for 11 weeks. She was extremely upset that her pain is affecting her quality of life. She stated that her physician is aware of these symptoms but "she could not do much". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart beating weird/heart palpitation, blurry vision, and muscle tightness, had not recovered from extremely bad headache, and the outcome of muscle soreness was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: 20211220830- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely bad headache. This event is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Musculoskeletal stiffness, Myalgia, Palpitations, Sensory disturbance
Clinical narrative: This spontaneous report received from a patient concerned a 54 year old female. The patient's height was not reported, but stated as to be a small woman and weight was about 80-90 pounds. The patient's concurrent conditions included: cervicogenic headache for 26 years, complex chronic pain, occasional alcohol use, gluten intolerance, red wine allergy, seasonal allergies and non smoker. The patient has no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with gabapentin, epinephrine/procaine hydrochloride, nortriptyline hydrochloride, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: UNKNOWN), 1 total, dose was not reported, administered to left arm on 21-SEP-2021 10:45 for prophylactic vaccination. Dose series was 1. No concomitant medications were reported. On 21-SEP-2021, around 4-5 PM she started experiencing a severe headache, her heart was beating weird, blurry vision, muscle tightness and aches all over her body (not just on the injection site). After vaccination, her headache got extremely bad and she thought that she was going to die and needed to go to emergency room. She reported her heart palpitation lasted for hours and hours. The adverse effects lasted for a few days. Some symptoms have calmed down but the headache has gotten worse and worse for 11 weeks. She was extremely upset that her pain is affecting her quality of life. She stated that her physician is aware of these symptoms but "she could not do much". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart beating weird/heart palpitation, blurry vision, and muscle tightness, had not recovered from extremely bad headache, and the outcome of muscle soreness was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: 20211220830- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely bad headache. This event is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: This spontaneous report received from a patient concerned a 54 year old female. The patient's height was not reported, but stated as to be a small woman and weight was about 80-90 pounds. The patient's concurrent conditions included: cervicogenic headache for 26 years, complex chronic pain, occasional alcohol use, gluten intolerance, red wine allergy, seasonal allergies and non smoker. The patient has no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with gabapentin, epinephrine/procaine hydrochloride, nortriptyline hydrochloride, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: UNKNOWN), 1 total, dose was not reported, administered to left arm on 21-SEP-2021 10:45 for prophylactic vaccination. Dose series was 1. No concomitant medications were reported. On 21-SEP-2021, around 4-5 PM she started experiencing a severe headache, her heart was beating weird, blurry vision, muscle tightness and aches all over her body (not just on the injection site). After vaccination, her headache got extremely bad and she thought that she was going to die and needed to go to emergency room. She reported her heart palpitation lasted for hours and hours. The adverse effects lasted for a few days. Some symptoms have calmed down but the headache has gotten worse and worse for 11 weeks. She was extremely upset that her pain is affecting her quality of life. She stated that her physician is aware of these symptoms but "she could not do much". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart beating weird/heart palpitation, blurry vision, and muscle tightness, had not recovered from extremely bad headache, and the outcome of muscle soreness was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: 20211220830- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely bad headache. This event is labeled per RSI and is therefore considered potentially related.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle rigidity, Myalgia, Palpitations, Vision blurred
Clinical narrative: This spontaneous report received from a patient concerned a 54 year old female. The patient's height was not reported, but stated as to be a small woman and weight was about 80-90 pounds. The patient's concurrent conditions included: cervicogenic headache for 26 years, complex chronic pain, occasional alcohol use, gluten intolerance, red wine allergy, seasonal allergies and non smoker. The patient has no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with gabapentin, epinephrine/procaine hydrochloride, nortriptyline hydrochloride, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: UNKNOWN), 1 total, dose was not reported, administered to left arm on 21-SEP-2021 10:45 for prophylactic vaccination. Dose series was 1. No concomitant medications were reported. On 21-SEP-2021, around 4-5 PM she started experiencing a severe headache, her heart was beating weird, blurry vision, muscle tightness and aches all over her body (not just on the injection site). After vaccination, her headache got extremely bad and she thought that she was going to die and needed to go to emergency room. She reported her heart palpitation lasted for hours and hours. The adverse effects lasted for a few days. Some symptoms have calmed down but the headache has gotten worse and worse for 11 weeks. She was extremely upset that her pain is affecting her quality of life. She stated that her physician is aware of these symptoms but "she could not do much". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart beating weird/heart palpitation, blurry vision, and muscle tightness, had not recovered from extremely bad headache, and the outcome of muscle soreness was not reported. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0: 20211220830- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Extremely bad headache. This event is labeled per RSI and is therefore considered potentially related.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Sudden death due to pulmonary embolism due to deep venous thrombosis. Thrombosis and embolism apparently started before vaccination based on the pathology. However, massive embolism occurred the day after the vaccination.  COVID testing negative. Information of the first dose unknown.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Blood caffeine, Cardiomegaly, Condition aggravated, Deep vein thrombosis
Clinical narrative: Sudden death due to pulmonary embolism due to deep venous thrombosis. Thrombosis and embolism apparently started before vaccination based on the pathology. However, massive embolism occurred the day after the vaccination.  COVID testing negative. Information of the first dose unknown.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic steatosis, Oedema peripheral, Pelvic venous thrombosis, Pulmonary embolism, Pulmonary infarction
Clinical narrative: Sudden death due to pulmonary embolism due to deep venous thrombosis. Thrombosis and embolism apparently started before vaccination based on the pathology. However, massive embolism occurred the day after the vaccination.  COVID testing negative. Information of the first dose unknown.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sudden death, Toxicologic test
Clinical narrative: Sudden death due to pulmonary embolism due to deep venous thrombosis. Thrombosis and embolism apparently started before vaccination based on the pathology. However, massive embolism occurred the day after the vaccination.  COVID testing negative. Information of the first dose unknown.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Vaccine positive rechallenge, Weight decreased
Clinical narrative: Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (COVAX US support 159558). The reporter is the patient. A 79-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; paroxetine (PAROXETINE), since 2014 (Batch/Lot number: unknown) at 1 mg 1x/day for anxiety, post-traumatic stress disorder; clonazepam (CLONAZEPAM AUDEN) (Batch/Lot number: unknown) at 1 mg for anxiety, post-traumatic stress disorder. Relevant medical history included: "low blood pressure" (unspecified if ongoing); "nervousness" (unspecified if ongoing); "Tremors" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). Past drug history included: Alprazolam, start date: 2003, stop date: 2019, for anxiety, reaction(s): "never had a single negative side effect from Alprazolam", notes: 1 mg; Alprazolam, start date: 2003, stop date: 2019, for PTSD, reaction(s): "never had a single negative side effect from Alprazolam". Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 immunization, reaction(s): "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands", "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands"; Bnt162b2 (Dose Number:02), for Covid-19 immunization, reaction(s): "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands", "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands". The following information was reported: IMMUNISATION (non-serious), DYSPNOEA (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for paroxetine and clonazepam was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.