chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1288 and expiry date: unknown), via an unspecified route of administration on the left shoulder, on 14Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing acid reflux, atrial fibrillation, and cholesterol. Concomitant medication included omeprazole, apixaban (ELIQUIS), and atorvastatin. Patient previously took pneumonia vaccine. On Jan2021, patient noticed an increased blood pressure (usually his BP is around 120, now has consistently been around 150). Prior to the shot, he has not been on blood pressure medication. His blood pressure usually runs high 120s to 130s on the top, and mid 50-60 on the bottom. His blood pressure prior to the vaccine that day was 132/56. Then a couple of days after the first shot, the top number of his blood pressure was in the high 150s, but the same on the bottom. Patient was wondering if he has a problem, or is this a side effect. He went in as a senior. He didn't have a prescribing doctor. The blood pressure difference started a couple of days after his first shot. He was scheduled for his second shot 4Feb2021. He has had no other side effects or anything. There was no swelling, no fever, no chills and he felt good. Just his blood pressure has been an issue. Outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient just had his first dose of the vaccine. He said before the vaccine, his blood pressure was in a normal range. After the first dose of the vaccine, he noticed that he was experiencing hypertension. The clinical outcome of hypertension was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Hypertension; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient just had his first dose of the vaccine. He said before the vaccine, his blood pressure was in a normal range. After the first dose of the vaccine, he noticed that he was experiencing hypertension. The clinical outcome of hypertension was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Hypertension; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient just had his first dose of the vaccine. He said before the vaccine, his blood pressure was in a normal range. After the first dose of the vaccine, he noticed that he was experiencing hypertension. The clinical outcome of hypertension was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Muscle contractions involuntary, Paraesthesia, Tongue paralysis
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Exercise tolerance decreased, Hypoaesthesia, Laboratory test
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging, Muscle contractions involuntary, Pain in extremity, Paraesthesia
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Tongue paralysis
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Facial paresis, Hypoaesthesia, Muscle contractions involuntary, Paraesthesia
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle contractions involuntary, Paraesthesia
Clinical narrative: I received covid vaccine Pfizer # 1 shot, 1/21/20 --  that evening had dermotomal paresthesia To r arm. also mild Facial numbness, that moved mostly to L face over next few days, then occasional foot tinglying, and now more feet and lower legs.   I am at day #11 and my symptoms are still present .   I am eagerly awaiting this to go away  Patient is a PA
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: sore arm where I could not lift, headache, nausea, tiredness
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Mobility decreased, Nausea, Pain, Pain in extremity
Clinical narrative: sore arm where I could not lift, headache, nausea, tiredness
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm where I could not lift, headache, nausea, tiredness
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: sore arm where I could not lift, headache, nausea, tiredness
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: more frequent falls, new inability to feed self, lower extremity paralysis, upper extremity weakness; onset of falls 01/17/2021; diagnosed with Guillain Barre syndrome 01/23/2021; treated with IVIG 01/23/2021-01/27/2021 without significant improvement; treated with plasmapheresis starting 01/31/2021; showing some improvement in lower extremity strength as of 02/04/2021, remains hospitalized
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal
Clinical narrative: more frequent falls, new inability to feed self, lower extremity paralysis, upper extremity weakness; onset of falls 01/17/2021; diagnosed with Guillain Barre syndrome 01/23/2021; treated with IVIG 01/23/2021-01/27/2021 without significant improvement; treated with plasmapheresis starting 01/31/2021; showing some improvement in lower extremity strength as of 02/04/2021, remains hospitalized
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative, Cerebral atrophy, Cerebral ventricle dilatation
Clinical narrative: more frequent falls, new inability to feed self, lower extremity paralysis, upper extremity weakness; onset of falls 01/17/2021; diagnosed with Guillain Barre syndrome 01/23/2021; treated with IVIG 01/23/2021-01/27/2021 without significant improvement; treated with plasmapheresis starting 01/31/2021; showing some improvement in lower extremity strength as of 02/04/2021, remains hospitalized
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Feeding disorder, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging brain abnormal
Clinical narrative: more frequent falls, new inability to feed self, lower extremity paralysis, upper extremity weakness; onset of falls 01/17/2021; diagnosed with Guillain Barre syndrome 01/23/2021; treated with IVIG 01/23/2021-01/27/2021 without significant improvement; treated with plasmapheresis starting 01/31/2021; showing some improvement in lower extremity strength as of 02/04/2021, remains hospitalized
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Monoplegia, Muscular weakness, Plasmapheresis, Spinal osteoarthritis
Clinical narrative: more frequent falls, new inability to feed self, lower extremity paralysis, upper extremity weakness; onset of falls 01/17/2021; diagnosed with Guillain Barre syndrome 01/23/2021; treated with IVIG 01/23/2021-01/27/2021 without significant improvement; treated with plasmapheresis starting 01/31/2021; showing some improvement in lower extremity strength as of 02/04/2021, remains hospitalized
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal stenosis, Vertebral foraminal stenosis, Xanthochromia
Clinical narrative: more frequent falls, new inability to feed self, lower extremity paralysis, upper extremity weakness; onset of falls 01/17/2021; diagnosed with Guillain Barre syndrome 01/23/2021; treated with IVIG 01/23/2021-01/27/2021 without significant improvement; treated with plasmapheresis starting 01/31/2021; showing some improvement in lower extremity strength as of 02/04/2021, remains hospitalized
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema
Clinical narrative: about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to swallow , constriction of throat.  i was given an epi pen and taken to Emergency at Medical Center.  I was released a couple hours later. I ended up going back to Emergency later on that evening but to Hospital.  Tongue started to swell up again and was getting constriction of the throat and hard to swallow.  Got released a couple hours later
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Mouth swelling, Swollen tongue, Throat tightness
Clinical narrative: about 10 minutes after receiving vaccine i got swelling of the tongue, mouth and a little hard to swallow , constriction of throat.  i was given an epi pen and taken to Emergency at Medical Center.  I was released a couple hours later. I ended up going back to Emergency later on that evening but to Hospital.  Tongue started to swell up again and was getting constriction of the throat and hard to swallow.  Got released a couple hours later
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pain reported near R elbow, distal to administration site on R arm, for 1-2 days after receiving vaccine. Pain resolved. 8 days after vaccine, patient developed red, warm and slightly swollen area about 10 cm diameter near R elbow in area where initial pain reported. Seen in clinic 1/29/21. Treated as cellulitis with cephalexin and ibuprofen for pain/swelling. Patient seen in clinic for follow up 2/1/21 and cellulitis almost completely resolved.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain reported near R elbow, distal to administration site on R arm, for 1-2 days after receiving vaccine. Pain resolved. 8 days after vaccine, patient developed red, warm and slightly swollen area about 10 cm diameter near R elbow in area where initial pain reported. Seen in clinic 1/29/21. Treated as cellulitis with cephalexin and ibuprofen for pain/swelling. Patient seen in clinic for follow up 2/1/21 and cellulitis almost completely resolved.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood pressure measurement
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Severe
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Nervous system disorder
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Neurological Disorder (diagnosed by MD)-Severe
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: EUA COVID-19 vaccine Moderna. Vaccinated with dose #1 of Moderna COVID-19 vaccine on 1/22. 1/23, client reports moderate arm soreness at the site of injection, joint aches and fatigue. She took ibuprofen 1/24 and 1/25, and "felt lousy" over the weekend. She noticed a spike in aches with chills on 1/25 approximately 3 hours post-exercise (strength training, moderate cardio). Fatigue and joint aches continued the rest of the week (through 1/30), but were not severe enough to limit normal activities or require ibuprofen or other meds. On 1/31, 9 days post vaccine, client reported a bilateral rash in the inner arm area. Within 24 hours, it spread to her torso and legs. Client is a nurse practitioner and described it as a "measles-like" rash; small raised dots, coalesced together in clumps that are largest on her thigh area, up to a foot in diameter. Warm to touch. Not a sandpaper rash. She denies itching or fever. This rash has been disappearing in order it appeared, and is still present on legs.The rash fading started 2/3 on inner arms, and client reports she can still feel the raised areas, but redness and warrmth is gone. Client did "Chat with a doctor" through telehealth and sent them a picture. Per her report, the provider said it may be a latent reaction to the vaccine, but is unsure if it's allergic. They offered a topical steroid which she declined. Client reports a history of topical allergic reaction on her face due to a cream, 10 years ago. She described it "like chemical burn", and was prescribed a PO steroid. She reports atopic dermatitis as child, but doesn't have eczema or consider herself to have sensitive skin right now. She also reports one case of pityriasis rosea when working with school age children, "text book" rash, 20 years ago.  Due for dose #2 of COVID vaccine 2/19. Client plans to go to an in-person visit at clinic for further assessment.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Malaise
Clinical narrative: EUA COVID-19 vaccine Moderna. Vaccinated with dose #1 of Moderna COVID-19 vaccine on 1/22. 1/23, client reports moderate arm soreness at the site of injection, joint aches and fatigue. She took ibuprofen 1/24 and 1/25, and "felt lousy" over the weekend. She noticed a spike in aches with chills on 1/25 approximately 3 hours post-exercise (strength training, moderate cardio). Fatigue and joint aches continued the rest of the week (through 1/30), but were not severe enough to limit normal activities or require ibuprofen or other meds. On 1/31, 9 days post vaccine, client reported a bilateral rash in the inner arm area. Within 24 hours, it spread to her torso and legs. Client is a nurse practitioner and described it as a "measles-like" rash; small raised dots, coalesced together in clumps that are largest on her thigh area, up to a foot in diameter. Warm to touch. Not a sandpaper rash. She denies itching or fever. This rash has been disappearing in order it appeared, and is still present on legs.The rash fading started 2/3 on inner arms, and client reports she can still feel the raised areas, but redness and warrmth is gone. Client did "Chat with a doctor" through telehealth and sent them a picture. Per her report, the provider said it may be a latent reaction to the vaccine, but is unsure if it's allergic. They offered a topical steroid which she declined. Client reports a history of topical allergic reaction on her face due to a cream, 10 years ago. She described it "like chemical burn", and was prescribed a PO steroid. She reports atopic dermatitis as child, but doesn't have eczema or consider herself to have sensitive skin right now. She also reports one case of pityriasis rosea when working with school age children, "text book" rash, 20 years ago.  Due for dose #2 of COVID vaccine 2/19. Client plans to go to an in-person visit at clinic for further assessment.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin warm
Clinical narrative: EUA COVID-19 vaccine Moderna. Vaccinated with dose #1 of Moderna COVID-19 vaccine on 1/22. 1/23, client reports moderate arm soreness at the site of injection, joint aches and fatigue. She took ibuprofen 1/24 and 1/25, and "felt lousy" over the weekend. She noticed a spike in aches with chills on 1/25 approximately 3 hours post-exercise (strength training, moderate cardio). Fatigue and joint aches continued the rest of the week (through 1/30), but were not severe enough to limit normal activities or require ibuprofen or other meds. On 1/31, 9 days post vaccine, client reported a bilateral rash in the inner arm area. Within 24 hours, it spread to her torso and legs. Client is a nurse practitioner and described it as a "measles-like" rash; small raised dots, coalesced together in clumps that are largest on her thigh area, up to a foot in diameter. Warm to touch. Not a sandpaper rash. She denies itching or fever. This rash has been disappearing in order it appeared, and is still present on legs.The rash fading started 2/3 on inner arms, and client reports she can still feel the raised areas, but redness and warrmth is gone. Client did "Chat with a doctor" through telehealth and sent them a picture. Per her report, the provider said it may be a latent reaction to the vaccine, but is unsure if it's allergic. They offered a topical steroid which she declined. Client reports a history of topical allergic reaction on her face due to a cream, 10 years ago. She described it "like chemical burn", and was prescribed a PO steroid. She reports atopic dermatitis as child, but doesn't have eczema or consider herself to have sensitive skin right now. She also reports one case of pityriasis rosea when working with school age children, "text book" rash, 20 years ago.  Due for dose #2 of COVID vaccine 2/19. Client plans to go to an in-person visit at clinic for further assessment.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fasciitis, Injection site pain, Lymphadenopathy, Magnetic resonance imaging abnormal
Clinical narrative: severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; lymphadenopathy as an MRI showed cervical lymph node enlargement; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received 1st dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient stated "Last Tuesday, I received my second vaccine. By Thursday I had severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. MRI showed cervical lymph node enlargement." The patient was hospitalized for severe left upper girdle pain in my shoulder and neck. eventually i was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis (fasciitis) for 4 days.  The patient underwent lab tests and procedures which included magnetic resonance imaging: cervical lymph node enlargement, pain assessment: 2-3 out of 10 on Jan2021.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported left upper girdle pain in shoulder and neck/ inflammatory fasciitis and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Neck pain
Clinical narrative: severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; lymphadenopathy as an MRI showed cervical lymph node enlargement; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received 1st dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient stated "Last Tuesday, I received my second vaccine. By Thursday I had severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. MRI showed cervical lymph node enlargement." The patient was hospitalized for severe left upper girdle pain in my shoulder and neck. eventually i was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis (fasciitis) for 4 days.  The patient underwent lab tests and procedures which included magnetic resonance imaging: cervical lymph node enlargement, pain assessment: 2-3 out of 10 on Jan2021.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported left upper girdle pain in shoulder and neck/ inflammatory fasciitis and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fasciitis, Laboratory test, Lymphadenopathy, Magnetic resonance imaging abnormal, Neck pain
Clinical narrative: severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; lymphadenopathy as an MRI showed cervical lymph node enlargement; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received 1st dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient stated "Last Tuesday, I received my second vaccine. By Thursday I had severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. MRI showed cervical lymph node enlargement." The patient was hospitalized for severe left upper girdle pain in my shoulder and neck. eventually i was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis (fasciitis) for 4 days.  The patient underwent lab tests and procedures which included magnetic resonance imaging: cervical lymph node enlargement, pain assessment: 2-3 out of 10 on Jan2021.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported left upper girdle pain in shoulder and neck/ inflammatory fasciitis and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Shoulder girdle pain
Clinical narrative: severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis; lymphadenopathy as an MRI showed cervical lymph node enlargement; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received 1st dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). The patient stated "Last Tuesday, I received my second vaccine. By Thursday I had severe left upper girdle pain in my shoulder and neck. Eventually I was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis. MRI showed cervical lymph node enlargement." The patient was hospitalized for severe left upper girdle pain in my shoulder and neck. eventually i was admitted to the hospital for four days for pain management and a workup which yielded a diagnosis of inflammatory fasciitis (fasciitis) for 4 days.  The patient underwent lab tests and procedures which included magnetic resonance imaging: cervical lymph node enlargement, pain assessment: 2-3 out of 10 on Jan2021.  The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported left upper girdle pain in shoulder and neck/ inflammatory fasciitis and the administration of the COVID-19 vaccine, BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema of eyelid, Eyelid rash, Rash
Clinical narrative: Patient received their first Moderna dose 12/31/2020 which was well tolerated.    Second dose on 1/28/21.  Was fine until the next day when developed headache.  1 1/2 days later she work up with erythematous itchy rash over eyelids. Lips became bright red with erythema around them. Slightly swollen. Cheeks that she self treated with benadryl 50 mg every 4-6 hours for days.  Swelling returned when benadryl would wear off. On 2/3 she was seen by a physician who referred her to an allergy specialist.  Upon that communication with the allergist, she was prescribed prednisone 20 mg for 3 days with excellent response. Last dose yesterday.   Allergra prescribed for dog allergy symptoms and flonse of allergic rhinitis.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Eyelid rash, Headache, Rash erythematous, Rash pruritic
Clinical narrative: Patient received their first Moderna dose 12/31/2020 which was well tolerated.    Second dose on 1/28/21.  Was fine until the next day when developed headache.  1 1/2 days later she work up with erythematous itchy rash over eyelids. Lips became bright red with erythema around them. Slightly swollen. Cheeks that she self treated with benadryl 50 mg every 4-6 hours for days.  Swelling returned when benadryl would wear off. On 2/3 she was seen by a physician who referred her to an allergy specialist.  Upon that communication with the allergist, she was prescribed prednisone 20 mg for 3 days with excellent response. Last dose yesterday.   Allergra prescribed for dog allergy symptoms and flonse of allergic rhinitis.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Swelling face
Clinical narrative: Patient received their first Moderna dose 12/31/2020 which was well tolerated.    Second dose on 1/28/21.  Was fine until the next day when developed headache.  1 1/2 days later she work up with erythematous itchy rash over eyelids. Lips became bright red with erythema around them. Slightly swollen. Cheeks that she self treated with benadryl 50 mg every 4-6 hours for days.  Swelling returned when benadryl would wear off. On 2/3 she was seen by a physician who referred her to an allergy specialist.  Upon that communication with the allergist, she was prescribed prednisone 20 mg for 3 days with excellent response. Last dose yesterday.   Allergra prescribed for dog allergy symptoms and flonse of allergic rhinitis.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Faeces discoloured, Fatigue
Clinical narrative: The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematochezia, Headache, Laboratory test, Nausea, Pain
Clinical narrative: The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Aspartate aminotransferase increased, Asthenia, Blood fibrinogen increased, Chills
Clinical narrative: The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Culture stool positive, Diarrhoea, Faeces discoloured, International normalised ratio normal, Metamyelocyte count increased
Clinical narrative: The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monocyte count increased, Nausea, Pyrexia, Rash
Clinical narrative: The night of the vaccine she woke up with: Diarrhea, black stools, weakness, fever, chills, stomach ache, nausea, rash on abdomen
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Cognitive disorder, Motor dysfunction, Psychomotor skills impaired, Speech disorder
Clinical narrative: Mild stroke.  Both sides of brain. Not hemorrhage. Clots
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Thrombosis
Clinical narrative: Mild stroke.  Both sides of brain. Not hemorrhage. Clots
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: patient had an anaphylactic reaction to the second dose of covid vaccine and was given 2 Benadryl and 2 doses of epi pen before being take by EMS to hospital
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: patient had an anaphylactic reaction to the second dose of covid vaccine and was given 2 Benadryl and 2 doses of epi pen before being take by EMS to hospital
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: . patient received vaccine on1/22/2021 . Patient had skin rash on 1/27/2021 below neck , macular rash which was not itchy or painful.  patient did not take any medication for it .  no fever. no oral lesions or angioedema  she is recovering from it without treatment
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: . patient received vaccine on1/22/2021 . Patient had skin rash on 1/27/2021 below neck , macular rash which was not itchy or painful.  patient did not take any medication for it .  no fever. no oral lesions or angioedema  she is recovering from it without treatment
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Liver function test increased, Rash, Rash macular, Red blood cell sedimentation rate increased
Clinical narrative: . patient received vaccine on1/22/2021 . Patient had skin rash on 1/27/2021 below neck , macular rash which was not itchy or painful.  patient did not take any medication for it .  no fever. no oral lesions or angioedema  she is recovering from it without treatment
Age: 71.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Left arm cellulitis distal to injection site
Age: 71.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Left arm cellulitis distal to injection site
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure orthostatic, Chest pain, Dizziness, Muscle tightness, Nausea
Clinical narrative: 80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining her first dose of the Moderna COVID-19 vaccine today, and about 10 minutes afterwards began feeling warm and diaphoretic and developing left chest pains and nausea, at approximately 11 AM.  This lasted about 5 minutes and then subsequently resolved.  She then got up to leave and again began feeling the left chest pain, diaphoresis, and again lasting about 5 to 6 minutes and then subsequently resolving.  She does state a history of anxiety but did take Xanax this morning preventatively.  However, she states she has had similar pains in her chest over the past month.  She states these are not necessarily associated with any exertion and seemed to be somewhat better after antacids.  She notes she has not had anything to eat or drink this morning which is not unusual for her and her blood sugar was 117 this morning.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Hyperhidrosis, Nausea, Skin warm
Clinical narrative: 80-year-old female with a history of atrial fibrillation and coronary artery disease, was obtaining her first dose of the Moderna COVID-19 vaccine today, and about 10 minutes afterwards began feeling warm and diaphoretic and developing left chest pains and nausea, at approximately 11 AM.  This lasted about 5 minutes and then subsequently resolved.  She then got up to leave and again began feeling the left chest pain, diaphoresis, and again lasting about 5 to 6 minutes and then subsequently resolving.  She does state a history of anxiety but did take Xanax this morning preventatively.  However, she states she has had similar pains in her chest over the past month.  She states these are not necessarily associated with any exertion and seemed to be somewhat better after antacids.  She notes she has not had anything to eat or drink this morning which is not unusual for her and her blood sugar was 117 this morning.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizziness Headache Diarrhea, Nausea, Vomiting Use of prescription medication
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Dizziness Headache Diarrhea, Nausea, Vomiting Use of prescription medication
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizziness Headache Diarrhea, Nausea, Vomiting Use of prescription medication
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pruritus, Vomiting
Clinical narrative: reachone 3 days later Vomiting, headache, tiredness, chills, itching
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Feeling abnormal, Pruritus, Throat tightness, Tremor
Clinical narrative: 1330 CG pre-treated with 100 mg of Benadryl prior to vaccine r/t previous c/o tongue tingling after first dose (pre-medicated). No concerns to accept second dose.  Always takes Benadryl with all vaccines (100mg prior and then 50mg Q4-6 X24 hrs based on symptoms) as directed by her PCP. CG understood possible risks of second dose.  CG took 4 days off in preparation.  Discussed history with vaccinator and observation nurse. 1430 received Moderna vaccine, 2nd dose 1440-1500 Alerted the Observation nurse she was feeling shaky, was alert and able to communicate, feeling of unease 1530 Mild rash, throat tickle/irritation, HR noted by observer to have a  transient drop 37 and back into the 60s 1550  EHN notified of situation. CG transferred to Twin Peaks conference room for privacy and started drawing up dose of Epi. Epi Held @ that time. 1605 Campus response called 1610 Campus Response team arrived.  BP 153/83, HR 68 Sats 100% RA 1615 BP 141/75, HR 66, Sats 97% RA.  Pt was diaphoretic and nauseated. Some mental confusion 1625 Report given to Campus Response and trans to PCH ED.  CG received Bendadryl, Epi and steroid.  Also had an abnormal EKG Caregiver was transferred to IMC ED and was discharge 0205/2021 @ 0300. Received another dose of bendadryl, magnisum and postassium (level was 2.5, usually 3.5-4) Sent home with Benadryl, prednisone and epi pen.  Instructed that this could continue to cycle the next few days.  02/05/2021 CG is doing well at home today.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: 1330 CG pre-treated with 100 mg of Benadryl prior to vaccine r/t previous c/o tongue tingling after first dose (pre-medicated). No concerns to accept second dose.  Always takes Benadryl with all vaccines (100mg prior and then 50mg Q4-6 X24 hrs based on symptoms) as directed by her PCP. CG understood possible risks of second dose.  CG took 4 days off in preparation.  Discussed history with vaccinator and observation nurse. 1430 received Moderna vaccine, 2nd dose 1440-1500 Alerted the Observation nurse she was feeling shaky, was alert and able to communicate, feeling of unease 1530 Mild rash, throat tickle/irritation, HR noted by observer to have a  transient drop 37 and back into the 60s 1550  EHN notified of situation. CG transferred to Twin Peaks conference room for privacy and started drawing up dose of Epi. Epi Held @ that time. 1605 Campus response called 1610 Campus Response team arrived.  BP 153/83, HR 68 Sats 100% RA 1615 BP 141/75, HR 66, Sats 97% RA.  Pt was diaphoretic and nauseated. Some mental confusion 1625 Report given to Campus Response and trans to PCH ED.  CG received Bendadryl, Epi and steroid.  Also had an abnormal EKG Caregiver was transferred to IMC ED and was discharge 0205/2021 @ 0300. Received another dose of bendadryl, magnisum and postassium (level was 2.5, usually 3.5-4) Sent home with Benadryl, prednisone and epi pen.  Instructed that this could continue to cycle the next few days.  02/05/2021 CG is doing well at home today.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium increased, Blood potassium decreased, Confusional state, Feeling abnormal, Heart rate decreased
Clinical narrative: 1330 CG pre-treated with 100 mg of Benadryl prior to vaccine r/t previous c/o tongue tingling after first dose (pre-medicated). No concerns to accept second dose.  Always takes Benadryl with all vaccines (100mg prior and then 50mg Q4-6 X24 hrs based on symptoms) as directed by her PCP. CG understood possible risks of second dose.  CG took 4 days off in preparation.  Discussed history with vaccinator and observation nurse. 1430 received Moderna vaccine, 2nd dose 1440-1500 Alerted the Observation nurse she was feeling shaky, was alert and able to communicate, feeling of unease 1530 Mild rash, throat tickle/irritation, HR noted by observer to have a  transient drop 37 and back into the 60s 1550  EHN notified of situation. CG transferred to Twin Peaks conference room for privacy and started drawing up dose of Epi. Epi Held @ that time. 1605 Campus response called 1610 Campus Response team arrived.  BP 153/83, HR 68 Sats 100% RA 1615 BP 141/75, HR 66, Sats 97% RA.  Pt was diaphoretic and nauseated. Some mental confusion 1625 Report given to Campus Response and trans to PCH ED.  CG received Bendadryl, Epi and steroid.  Also had an abnormal EKG Caregiver was transferred to IMC ED and was discharge 0205/2021 @ 0300. Received another dose of bendadryl, magnisum and postassium (level was 2.5, usually 3.5-4) Sent home with Benadryl, prednisone and epi pen.  Instructed that this could continue to cycle the next few days.  02/05/2021 CG is doing well at home today.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Nausea, Nervousness, Paraesthesia oral, Rash
Clinical narrative: 1330 CG pre-treated with 100 mg of Benadryl prior to vaccine r/t previous c/o tongue tingling after first dose (pre-medicated). No concerns to accept second dose.  Always takes Benadryl with all vaccines (100mg prior and then 50mg Q4-6 X24 hrs based on symptoms) as directed by her PCP. CG understood possible risks of second dose.  CG took 4 days off in preparation.  Discussed history with vaccinator and observation nurse. 1430 received Moderna vaccine, 2nd dose 1440-1500 Alerted the Observation nurse she was feeling shaky, was alert and able to communicate, feeling of unease 1530 Mild rash, throat tickle/irritation, HR noted by observer to have a  transient drop 37 and back into the 60s 1550  EHN notified of situation. CG transferred to Twin Peaks conference room for privacy and started drawing up dose of Epi. Epi Held @ that time. 1605 Campus response called 1610 Campus Response team arrived.  BP 153/83, HR 68 Sats 100% RA 1615 BP 141/75, HR 66, Sats 97% RA.  Pt was diaphoretic and nauseated. Some mental confusion 1625 Report given to Campus Response and trans to PCH ED.  CG received Bendadryl, Epi and steroid.  Also had an abnormal EKG Caregiver was transferred to IMC ED and was discharge 0205/2021 @ 0300. Received another dose of bendadryl, magnisum and postassium (level was 2.5, usually 3.5-4) Sent home with Benadryl, prednisone and epi pen.  Instructed that this could continue to cycle the next few days.  02/05/2021 CG is doing well at home today.