chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: BODY ACHES; BRAIN FOG; ARM WAS EXTREMELY SORE FROM SHOULDER TO ELBOW; CHILLS; FEVER; CHEST PAIN; HEAD FELT HOT; RACING HEART; BODY TINGLING; LIGHTHEADED; LIP AND TONGUE TINGLING; LIP SWELLING; FACE FEELS TIGHT; WHOLE BODY NUMBNESS; TONGUE SWELLING; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 around 12:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced lip and tongue tingling. On 06-APR-2021, the subject experienced lip swelling. On 06-APR-2021, the subject experienced face feels tight. On 06-APR-2021, the subject experienced whole body numbness. On 06-APR-2021, the subject experienced tongue swelling. On 06-APR-2021 12:30, the subject experienced racing heart. On 06-APR-2021 12:30, the subject experienced body tingling. On 06-APR-2021 12:30, the subject experienced lightheaded. On 06-APR-2021 15:30, the subject experienced head felt hot. On 06-APR-2021 16:30, the subject experienced chest pain. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced brain fog. On 07-APR-2021, the subject experienced arm was extremely sore from shoulder to elbow. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) more than 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, body tingling, lightheaded, lip and tongue tingling, lip swelling, face feels tight, whole body numbness, head felt hot, chest pain, and tongue swelling on 06-APR-2021, and had not recovered from fever, body aches, chills, brain fog, and arm was extremely sore from shoulder to elbow. This report was non-serious. This case, from the same reporter is linked to 20210415021.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dehydration, Diarrhoea, Headache, Pyrexia
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Diarrhoea, Epistaxis, Eye movement disorder
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Loss of consciousness, Migraine, Muscular weakness
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Neuralgia, Paralysis, Peripheral swelling
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pruritus, Pyrexia, SARS-CoV-2 test negative, Sciatica
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Throat irritation
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Dizziness, Eye swelling
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Migraine, Nasal oedema, Nausea, Paralysis
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: started with watery diarrhea, followed by typical fatigue low grade fever migraine and muscle aches by 8pm 4/6/21. by 2am 4/7/21 felt my eyes roll back, lost 2ish hours of consciousness, checked temperate and was 103.7. i felt paralyzed by 4ish am. could not move lower half before 7am, regaining weak movement in upper body. by 8am could barely move my lower half, using a cane to get to the restroom a few steps away from bed.  arm that was injected, throat, nose, eyes were all swollen. primary doctor and pharmacist both said to go to ER. went there once i was able to secure a ride and childcare. ER doctor requested blood work and covid test. covid test was negative, blood work came back normal. had a bloody nose before i came home. diagnosed there with post vaccination reaction. told to take benadryl and ibuprofen/tylenol. each day i woke after vaccination unable to move my neck (including today). it takes me several hours to be able to move my neck muscles. waking up 4/8/21 my right side was temporarily paralyzed but regained slow achy movement throughout the day. each day after vaccination joint pain somewhere in my body takes place and nerve pain is often associated. 4/10/21-4/13/21 i have experienced sciatic nerve pain down both sides all the way down to my toes. my nose and throat are still swollen. i am still having to take benadryl daily due to throat swelling. my throat and neck itch.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea
Clinical narrative: Trouble breathing as the shot was administered. Vision began to black out after 3 minutes. Urge to vomit, extreme nausea. Passed out, unconscious within 5 minutes of receiving the shot. Could not sit up/dizzy for 30 minutes. Nausea, weakness, dizzy, poor mental acuity/memory. Later that night, and through the night for 10 hours, severe back pain. Nausea, severe weakness, dizzy, poor mental acuity and memory, sweats and chills.  The next day (day immediately after receiving vaccine) symptoms continued but lessened by 5 pm. Each day since then, the symptoms have ALL remained in a more mild form. Today is day 6 and I still have moderate back pain and occasional sweats, weakness and fatigue.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Trouble breathing as the shot was administered. Vision began to black out after 3 minutes. Urge to vomit, extreme nausea. Passed out, unconscious within 5 minutes of receiving the shot. Could not sit up/dizzy for 30 minutes. Nausea, weakness, dizzy, poor mental acuity/memory. Later that night, and through the night for 10 hours, severe back pain. Nausea, severe weakness, dizzy, poor mental acuity and memory, sweats and chills.  The next day (day immediately after receiving vaccine) symptoms continued but lessened by 5 pm. Each day since then, the symptoms have ALL remained in a more mild form. Today is day 6 and I still have moderate back pain and occasional sweats, weakness and fatigue.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Mental impairment, Nausea
Clinical narrative: Trouble breathing as the shot was administered. Vision began to black out after 3 minutes. Urge to vomit, extreme nausea. Passed out, unconscious within 5 minutes of receiving the shot. Could not sit up/dizzy for 30 minutes. Nausea, weakness, dizzy, poor mental acuity/memory. Later that night, and through the night for 10 hours, severe back pain. Nausea, severe weakness, dizzy, poor mental acuity and memory, sweats and chills.  The next day (day immediately after receiving vaccine) symptoms continued but lessened by 5 pm. Each day since then, the symptoms have ALL remained in a more mild form. Today is day 6 and I still have moderate back pain and occasional sweats, weakness and fatigue.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: OVERDOSE (RECEIVED 5 TIMES THE NORMAL DOSE OF THE VACCINE); This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201AZ1A, expiry: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced overdose (received 5 times the normal dose of the vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overdose (received 5 times the normal dose of the vaccine). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Overdose
Clinical narrative: OVERDOSE (RECEIVED 5 TIMES THE NORMAL DOSE OF THE VACCINE); This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201AZ1A, expiry: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced overdose (received 5 times the normal dose of the vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overdose (received 5 times the normal dose of the vaccine). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Extra dose administered
Clinical narrative: OVERDOSE (RECEIVED 5 TIMES THE NORMAL DOSE OF THE VACCINE); This spontaneous report received from a patient concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 201AZ1A, expiry: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced overdose (received 5 times the normal dose of the vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from overdose (received 5 times the normal dose of the vaccine). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Ischaemic stroke, Magnetic resonance imaging head, Thrombosis, Ultrasound scan
Clinical narrative: The adverse events include severe headache for about a week after receiving vaccine, which resulted in a collapse and emergently being brought to the emergency room via ambulance where a CT revealed a stroke with emergent IR procedure with admittance to an ICU. This was complicated by an emergent  craniotomy due to increased brain swelling and brain deviation/herniation which was life threatening, which resulted in repeated intubation. Now currently in ICU with frequent checks and monitoring for life saving medical care.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain herniation, Brain oedema, Cerebrovascular accident, Computerised tomogram abnormal, Craniotomy
Clinical narrative: The adverse events include severe headache for about a week after receiving vaccine, which resulted in a collapse and emergently being brought to the emergency room via ambulance where a CT revealed a stroke with emergent IR procedure with admittance to an ICU. This was complicated by an emergent  craniotomy due to increased brain swelling and brain deviation/herniation which was life threatening, which resulted in repeated intubation. Now currently in ICU with frequent checks and monitoring for life saving medical care.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Headache, Intensive care, Interventional procedure, Syncope
Clinical narrative: The adverse events include severe headache for about a week after receiving vaccine, which resulted in a collapse and emergently being brought to the emergency room via ambulance where a CT revealed a stroke with emergent IR procedure with admittance to an ICU. This was complicated by an emergent  craniotomy due to increased brain swelling and brain deviation/herniation which was life threatening, which resulted in repeated intubation. Now currently in ICU with frequent checks and monitoring for life saving medical care.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Craniotomy, Haemorrhagic diathesis, Thrombocytopenia
Clinical narrative: The adverse events include severe headache for about a week after receiving vaccine, which resulted in a collapse and emergently being brought to the emergency room via ambulance where a CT revealed a stroke with emergent IR procedure with admittance to an ICU. This was complicated by an emergent  craniotomy due to increased brain swelling and brain deviation/herniation which was life threatening, which resulted in repeated intubation. Now currently in ICU with frequent checks and monitoring for life saving medical care.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Ischaemic stroke, Magnetic resonance imaging head, Thrombosis, Ultrasound scan
Clinical narrative: Severe clotting diathesis (systemic and intracranial) causing severe stroke requiring craniotomy, thrombocytopenia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain herniation, Brain oedema, Cerebrovascular accident, Computerised tomogram abnormal, Craniotomy
Clinical narrative: Severe clotting diathesis (systemic and intracranial) causing severe stroke requiring craniotomy, thrombocytopenia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Headache, Intensive care, Interventional procedure, Syncope
Clinical narrative: Severe clotting diathesis (systemic and intracranial) causing severe stroke requiring craniotomy, thrombocytopenia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Craniotomy, Haemorrhagic diathesis, Thrombocytopenia
Clinical narrative: Severe clotting diathesis (systemic and intracranial) causing severe stroke requiring craniotomy, thrombocytopenia
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram neck, Computerised tomogram thorax, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2  administration. The impacts 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Lymphadenopathy, Odynophagia, Pain, Pyrexia
Clinical narrative: shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2  administration. The impacts 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2  administration. The impacts 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Lymphadenopathy, Odynophagia
Clinical narrative: shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2  administration. The impacts 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Swelling face, Vomiting
Clinical narrative: shortness of breath; 2 days post vaccine small hard lump under chin developed.; 4 days post vaccine lump / lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen; chills; fever; fatigue; body aches; vomiting; painful to swallow; This is a spontaneous report from a contactable Other-HCP (patient). A 40-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6206, Expiration date was not provided) via unspecified route of administration at left arm on 18Mar2021 09:30 at single dose for COVID-19 immunisation. The patient medical history included type 1 diabetes and Sulfa drugs. Concomitant medications included insulin human (HUMULIN R), insulin human injection, isophane (HUMULIN N) and sildenafil. Historical vaccine included first dose of BNT162B2 (lot number: EN6202) via unspecified route of administration on right arm on 25Feb2021 12:30 PM for COVID-19 immunisation. If other vaccine in four weeks and Covid prior vaccination reported as no. Patient tested Covid post vaccination. On 20Mar2021 09:00, 2 days post vaccine small hard lump under chin developed. 4 days post vaccine lump/lymph nodes severely enlarged the size of a racquet ball and area around chin and neck severely swollen. The subject developed chills, fever, fatigue, body aches, shortness of breath, vomiting, painful to swallow. Due to pain from swelling Percocet , Fentanyl, Ketorolac, and Morphine were administered. It is also reported that the subject received antibiotics for the adverse events. 2 COVID test were negative. Due to difficulty breathing issues the subject was admitted through ER to hospital critical care unit for 9 days post vaccine. The subject was still in hospital 11 days post vaccine. The patient underwent lab test procedure included Nasal Swab (SARS-CoV-2 test): Negative on 26Mar2021 and Negative on 27Mar2021. The outcome of the events was not recovered.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between the reported, serious dyspnea and BNT162B2  administration. The impacts 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Light headed, nausea, syncope, vomited, Level of consciousness was diminished prior to leaving after receiving her vaccine. > First VS:  140/83, Pulse 88, RR 18, Oxygen 97% > Second VS: 123/74, pulse 76, RR 18, Oxygen 93%  Transport checked VS in the ambulance and she refused transportation.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Dizziness, Nausea, Syncope, Vital signs measurement
Clinical narrative: Light headed, nausea, syncope, vomited, Level of consciousness was diminished prior to leaving after receiving her vaccine. > First VS:  140/83, Pulse 88, RR 18, Oxygen 97% > Second VS: 123/74, pulse 76, RR 18, Oxygen 93%  Transport checked VS in the ambulance and she refused transportation.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Light headed, nausea, syncope, vomited, Level of consciousness was diminished prior to leaving after receiving her vaccine. > First VS:  140/83, Pulse 88, RR 18, Oxygen 97% > Second VS: 123/74, pulse 76, RR 18, Oxygen 93%  Transport checked VS in the ambulance and she refused transportation.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Headache, Lethargy
Clinical narrative: GENERAL RESTLESSNESS; HEART PALPITATIONS; SEVERE CHILLS AFTER 7 HOURS OF VACCINE; POUNDING HEAD/HEADACHE; GENERAL FATIGUE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 195 pounds, and height was 76 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and alcohol use, and other pre-existing medical conditions included patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced general restlessness. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced severe chills after 7 hours of vaccine. On 07-APR-2021, the subject experienced pounding head/headache. On 07-APR-2021, the subject experienced general fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, and severe chills after 7 hours of vaccine on 08-APR-2021, and had not recovered from pounding head/headache, general restlessness, and general fatigue. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Palpitations, Restlessness
Clinical narrative: GENERAL RESTLESSNESS; HEART PALPITATIONS; SEVERE CHILLS AFTER 7 HOURS OF VACCINE; POUNDING HEAD/HEADACHE; GENERAL FATIGUE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 195 pounds, and height was 76 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and alcohol use, and other pre-existing medical conditions included patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced general restlessness. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced severe chills after 7 hours of vaccine. On 07-APR-2021, the subject experienced pounding head/headache. On 07-APR-2021, the subject experienced general fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, and severe chills after 7 hours of vaccine on 08-APR-2021, and had not recovered from pounding head/headache, general restlessness, and general fatigue. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Patient noticed upper lip swelling the morning of 4/8/21.  They went to Urgent Care where they recieved a prescription for methylprednisolone and Zyrtec.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Arm hot, severely bruised, lump in arm from 3/31/21 at 8pm until 4/13/21 arm still has large lump and bruising that has not gone away the chills and sweats stopped 1 week after injection date also had a large lump raised out of my chest that is on the right side as well the provider contributed to the cellulites that was affecting the right arm that the injection was done and the lump has not gone down either Dermatologist believes that it is a inflamed lymph node in my chest from the shot the lump is hard and painful.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: Arm hot, severely bruised, lump in arm from 3/31/21 at 8pm until 4/13/21 arm still has large lump and bruising that has not gone away the chills and sweats stopped 1 week after injection date also had a large lump raised out of my chest that is on the right side as well the provider contributed to the cellulites that was affecting the right arm that the injection was done and the lump has not gone down either Dermatologist believes that it is a inflamed lymph node in my chest from the shot the lump is hard and painful.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Chills, Contusion, Hyperhidrosis, Injection site mass
Clinical narrative: Arm hot, severely bruised, lump in arm from 3/31/21 at 8pm until 4/13/21 arm still has large lump and bruising that has not gone away the chills and sweats stopped 1 week after injection date also had a large lump raised out of my chest that is on the right side as well the provider contributed to the cellulites that was affecting the right arm that the injection was done and the lump has not gone down either Dermatologist believes that it is a inflamed lymph node in my chest from the shot the lump is hard and painful.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lymphadenitis, Mass, Skin warm
Clinical narrative: Arm hot, severely bruised, lump in arm from 3/31/21 at 8pm until 4/13/21 arm still has large lump and bruising that has not gone away the chills and sweats stopped 1 week after injection date also had a large lump raised out of my chest that is on the right side as well the provider contributed to the cellulites that was affecting the right arm that the injection was done and the lump has not gone down either Dermatologist believes that it is a inflamed lymph node in my chest from the shot the lump is hard and painful.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Received vaccine in 3/20. On 3/25, developed a pruritic, erythematous papular rash over abdomen, under breasts, axillae, behind knees and elbows. Continued to worse so was prescribed oral prednisone, which helped to improved sx. After completing 6-day course, the rash returned so was prescribed topical triamcinolone on 4/8.  Was taking BID and sx have continued to improved so decreased to once daily. Still has mild but generalized pruritus. Saw PCP who performed lab tests as part of annual physical, results pending. Has upcoming appointment with allergist.   Of note, recently started taking the supplements listed in the medication section about 1 month ago.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: Received vaccine in 3/20. On 3/25, developed a pruritic, erythematous papular rash over abdomen, under breasts, axillae, behind knees and elbows. Continued to worse so was prescribed oral prednisone, which helped to improved sx. After completing 6-day course, the rash returned so was prescribed topical triamcinolone on 4/8.  Was taking BID and sx have continued to improved so decreased to once daily. Still has mild but generalized pruritus. Saw PCP who performed lab tests as part of annual physical, results pending. Has upcoming appointment with allergist.   Of note, recently started taking the supplements listed in the medication section about 1 month ago.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Received vaccine in 3/20. On 3/25, developed a pruritic, erythematous papular rash over abdomen, under breasts, axillae, behind knees and elbows. Continued to worse so was prescribed oral prednisone, which helped to improved sx. After completing 6-day course, the rash returned so was prescribed topical triamcinolone on 4/8.  Was taking BID and sx have continued to improved so decreased to once daily. Still has mild but generalized pruritus. Saw PCP who performed lab tests as part of annual physical, results pending. Has upcoming appointment with allergist.   Of note, recently started taking the supplements listed in the medication section about 1 month ago.