chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ambulatory abnormal, Fibrin D dimer increased, Heart rate irregular, Hepatic enzyme increased, Hypoaesthesia
Clinical narrative: 06/21/22 - Day of second dose. Within the first 15 minutes I felt dizzy and unwell. The pharmacist handed me a bottle of water and I waited an additional 15 minutes. Afterward I felt safe to go home. Later that day I went to the ER with chest pain. I had a normal EKG and was sent home.  06/23/22 - The chest pain was worse and I also felt short of breath. I went to an ER and was given Ibuprofen 800 after they determined I wasn't having an emergency via EKG and CT scan following an elevated d-dimer.  Around this time I noticed a small palpable mass behind my left knee.   07/07/22 - Concerning chest pain, ER, sent home after an unremarkable x-ray.  07/12/22 - First appointment with new PCP. I'm referred to a cardiologist.  07/14/22 - Fasting labs. Unremarkable aside from mildly elevated liver enzymes.  07/21/22 - Chest and pain, bounding pulse, ER, kept overnight after they found elevated troponin. EKG was also abnormal, nonspecific t wave abnormality.  07/22/22 - Cardiology consult. EKG was borderline, I was never given a copy so I don't remember the specifics.  08/08/22 - Normal stress echo. Given a Holler monitor to wear for two weeks. No abnormal findings other than PVCs. I was never given the exact amount and don?t have access to the data.  Late August I noticed pain in my left knee.   09/02/22 - I was diagnosed with a DVT. I was given Xarelto, 15mg to take twice a day for 21 days.  09/03/22 - Hospitalized after complaints of chest pain that differed from my usual and tachycardia. They did not find anything immediately concerning and I was released the next afternoon.  09/14/22 - Met with PCP. Referred to hematologist.  09/21/22 - Hematologist took labs, concerned about possible autoimmunity. As of 09/29/22 I have access to a few of the results. My ANA is 1:320, homogenous. I?ll know more 10/05/22, my next appointment.  All of the symptoms I can remember: chest pain, shortness of breath, erratic heart rate that would dramatically change when I?d move around even slightly, random episodes of tachycardia, PVCs, stabbing pains and numbness in my extremities, increased vein visibility, a throat sensation that felt like being choked, inability to breathe deeply.  As of 09/29/22 my remaining symptoms are PVCs and occasional cold/numb extremities.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Limb mass, Malaise, Pain in extremity, Peripheral coldness
Clinical narrative: 06/21/22 - Day of second dose. Within the first 15 minutes I felt dizzy and unwell. The pharmacist handed me a bottle of water and I waited an additional 15 minutes. Afterward I felt safe to go home. Later that day I went to the ER with chest pain. I had a normal EKG and was sent home.  06/23/22 - The chest pain was worse and I also felt short of breath. I went to an ER and was given Ibuprofen 800 after they determined I wasn't having an emergency via EKG and CT scan following an elevated d-dimer.  Around this time I noticed a small palpable mass behind my left knee.   07/07/22 - Concerning chest pain, ER, sent home after an unremarkable x-ray.  07/12/22 - First appointment with new PCP. I'm referred to a cardiologist.  07/14/22 - Fasting labs. Unremarkable aside from mildly elevated liver enzymes.  07/21/22 - Chest and pain, bounding pulse, ER, kept overnight after they found elevated troponin. EKG was also abnormal, nonspecific t wave abnormality.  07/22/22 - Cardiology consult. EKG was borderline, I was never given a copy so I don't remember the specifics.  08/08/22 - Normal stress echo. Given a Holler monitor to wear for two weeks. No abnormal findings other than PVCs. I was never given the exact amount and don?t have access to the data.  Late August I noticed pain in my left knee.   09/02/22 - I was diagnosed with a DVT. I was given Xarelto, 15mg to take twice a day for 21 days.  09/03/22 - Hospitalized after complaints of chest pain that differed from my usual and tachycardia. They did not find anything immediately concerning and I was released the next afternoon.  09/14/22 - Met with PCP. Referred to hematologist.  09/21/22 - Hematologist took labs, concerned about possible autoimmunity. As of 09/29/22 I have access to a few of the results. My ANA is 1:320, homogenous. I?ll know more 10/05/22, my next appointment.  All of the symptoms I can remember: chest pain, shortness of breath, erratic heart rate that would dramatically change when I?d move around even slightly, random episodes of tachycardia, PVCs, stabbing pains and numbness in my extremities, increased vein visibility, a throat sensation that felt like being choked, inability to breathe deeply.  As of 09/29/22 my remaining symptoms are PVCs and occasional cold/numb extremities.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulse abnormal, Stress echocardiogram normal, Tachycardia, Vein disorder, Ventricular extrasystoles
Clinical narrative: 06/21/22 - Day of second dose. Within the first 15 minutes I felt dizzy and unwell. The pharmacist handed me a bottle of water and I waited an additional 15 minutes. Afterward I felt safe to go home. Later that day I went to the ER with chest pain. I had a normal EKG and was sent home.  06/23/22 - The chest pain was worse and I also felt short of breath. I went to an ER and was given Ibuprofen 800 after they determined I wasn't having an emergency via EKG and CT scan following an elevated d-dimer.  Around this time I noticed a small palpable mass behind my left knee.   07/07/22 - Concerning chest pain, ER, sent home after an unremarkable x-ray.  07/12/22 - First appointment with new PCP. I'm referred to a cardiologist.  07/14/22 - Fasting labs. Unremarkable aside from mildly elevated liver enzymes.  07/21/22 - Chest and pain, bounding pulse, ER, kept overnight after they found elevated troponin. EKG was also abnormal, nonspecific t wave abnormality.  07/22/22 - Cardiology consult. EKG was borderline, I was never given a copy so I don't remember the specifics.  08/08/22 - Normal stress echo. Given a Holler monitor to wear for two weeks. No abnormal findings other than PVCs. I was never given the exact amount and don?t have access to the data.  Late August I noticed pain in my left knee.   09/02/22 - I was diagnosed with a DVT. I was given Xarelto, 15mg to take twice a day for 21 days.  09/03/22 - Hospitalized after complaints of chest pain that differed from my usual and tachycardia. They did not find anything immediately concerning and I was released the next afternoon.  09/14/22 - Met with PCP. Referred to hematologist.  09/21/22 - Hematologist took labs, concerned about possible autoimmunity. As of 09/29/22 I have access to a few of the results. My ANA is 1:320, homogenous. I?ll know more 10/05/22, my next appointment.  All of the symptoms I can remember: chest pain, shortness of breath, erratic heart rate that would dramatically change when I?d move around even slightly, random episodes of tachycardia, PVCs, stabbing pains and numbness in my extremities, increased vein visibility, a throat sensation that felt like being choked, inability to breathe deeply.  As of 09/29/22 my remaining symptoms are PVCs and occasional cold/numb extremities.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: 06/21/22 - Day of second dose. Within the first 15 minutes I felt dizzy and unwell. The pharmacist handed me a bottle of water and I waited an additional 15 minutes. Afterward I felt safe to go home. Later that day I went to the ER with chest pain. I had a normal EKG and was sent home.  06/23/22 - The chest pain was worse and I also felt short of breath. I went to an ER and was given Ibuprofen 800 after they determined I wasn't having an emergency via EKG and CT scan following an elevated d-dimer.  Around this time I noticed a small palpable mass behind my left knee.   07/07/22 - Concerning chest pain, ER, sent home after an unremarkable x-ray.  07/12/22 - First appointment with new PCP. I'm referred to a cardiologist.  07/14/22 - Fasting labs. Unremarkable aside from mildly elevated liver enzymes.  07/21/22 - Chest and pain, bounding pulse, ER, kept overnight after they found elevated troponin. EKG was also abnormal, nonspecific t wave abnormality.  07/22/22 - Cardiology consult. EKG was borderline, I was never given a copy so I don't remember the specifics.  08/08/22 - Normal stress echo. Given a Holler monitor to wear for two weeks. No abnormal findings other than PVCs. I was never given the exact amount and don?t have access to the data.  Late August I noticed pain in my left knee.   09/02/22 - I was diagnosed with a DVT. I was given Xarelto, 15mg to take twice a day for 21 days.  09/03/22 - Hospitalized after complaints of chest pain that differed from my usual and tachycardia. They did not find anything immediately concerning and I was released the next afternoon.  09/14/22 - Met with PCP. Referred to hematologist.  09/21/22 - Hematologist took labs, concerned about possible autoimmunity. As of 09/29/22 I have access to a few of the results. My ANA is 1:320, homogenous. I?ll know more 10/05/22, my next appointment.  All of the symptoms I can remember: chest pain, shortness of breath, erratic heart rate that would dramatically change when I?d move around even slightly, random episodes of tachycardia, PVCs, stabbing pains and numbness in my extremities, increased vein visibility, a throat sensation that felt like being choked, inability to breathe deeply.  As of 09/29/22 my remaining symptoms are PVCs and occasional cold/numb extremities.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I caught Covid
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Feeling hot, Headache, Heart rate increased, Hypertension
Clinical narrative: started to feel nauseous and hot.  he had a headache later and high blood pressure and heart rate
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: started to feel nauseous and hot.  he had a headache later and high blood pressure and heart rate
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Patient complained of redness and itchiness on her left arm where she got the vaccine. The symptom onset was 9/27/2022. The redness expanded from her upper arm to lower arm, but the redness has gone down. She has been self treating at home to relieve itchiness, but has not informed her doctor yet. No signs of infection. Looked like an allergic reaction. Have informed the patient to contact the doctor.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Headache, nausea, joint aches, fatigue
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Vomiting
Clinical narrative: Patient described extreme chills the morning after the vaccine. She reports vomiting the morning after shot. She describes feeling very fatigued for 3 days after vaccine.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Seizure
Clinical narrative: Pt reported that he had a seizure at night on the same day he received the Fluzone HD vaccination. He reported that he went to the ER but that he is okay now. He has had this same vaccination multiple times in past with no reaction.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Cerebral small vessel ischaemic disease, Computerised tomogram head normal, Confusional state, Lacunar infarction, Tremor
Clinical narrative: Pt reported that he had a seizure at night on the same day he received the Fluzone HD vaccination. He reported that he went to the ER but that he is okay now. He has had this same vaccination multiple times in past with no reaction.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urinary incontinence
Clinical narrative: Pt reported that he had a seizure at night on the same day he received the Fluzone HD vaccination. He reported that he went to the ER but that he is okay now. He has had this same vaccination multiple times in past with no reaction.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given Pfizer bivalent COVID vaccine instead of first primary dose. Patient has not reported an adverse event.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Heightened heart rate, almost fainted. Dizziness and lightheaded.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: At 1700,  A family arrived  at clinic to receive vaccines. There were 4 people in the vehicle wanting to be vaccinated two adults and two children. The children were a 2 y/o Female and a 4 y/o female . Their parent requested that they receive their third dose  of infant pfizer. Rather than being given the infant pfizer they recieved pediactric  pfizer around 1712 . Following the event. The family was observed in observation for 15 minutes and no adverse reactions noted or abnormalities. The family left following this. The mother of the patient's was contacted, informed of the med error, and advised to notify the pediatrician to follow up.  At the time of this phone call (1820), the mother stated that no adverse reaction symptoms were noted.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: At 1700,  A family arrived  at clinic to receive vaccines. There were 4 people in the vehicle wanting to be vaccinated two adults and two children. The children were a 2 y/o Female and a 4 y/o female . Their parent requested that they receive their third dose  of infant pfizer. Rather than being given the infant pfizer they recieved pediactric  pfizer around 1712 . Following the event. The family was observed in observation for 15 minutes and no adverse reactions noted or abnormalities. The family left following this. The mother of the children, was contacted, informed of the med error, and advised to notify the pediatrician to follow up.  At the time of this phone call (1820), the mother stated that no adverse reaction symptoms were noted.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Blister, Blood culture, Erythema, Full blood count, Induration
Clinical narrative: necrotic blister surrounding erythema and induration one day after administration and lymphangitic streaking proximally two days after administration
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Lymphangitis, Necrosis
Clinical narrative: necrotic blister surrounding erythema and induration one day after administration and lymphangitic streaking proximally two days after administration
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body ache  Fever Chills  Headache
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site reaction, Rash papular
Clinical narrative: Raised rash at injection site
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: The patient came on 09/23/22 to get his bivalent booster. His CDC card showed the date he got the second booster as 06/22 and hence since 2 months have been passed he was given the booster. But when his wife came to get the booster on 09/28/22, the card showed 8/22 instead and  she did not qualify. She questioned why her husband was given the shot and looking at the card the 8 looked like a 6 and hence the mistake happened.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: Immediately after vaccination, patient followed father both were walking around the store.  After a few minutes the patient fell to his knees then slouched onto the floor.  The Father said he appeared unconscious.  When rubbing his chest, the patient became conscious again and said he felt dizzy.  Patient was put on a chair and looked pale and then the pharmacy was notified.
Age: 89.0
Sex: F
Vaccine: COVID19-2, FLU3
Symptoms: Incomplete course of vaccination, Interchange of vaccine products
Clinical narrative: Patient was given Moderna Bivalent as a second covid vaccine. Patient did not complete the initial series of Pfizer covid vaccine prior to this given.
Sex: M
Vaccine: COVID19-2
Symptoms: Erythema, Herpes zoster, Neuralgia, Trigeminal neuralgia
Clinical narrative: unknown if directly related to COVID vaccine however patient presented 9/24/22 for symptoms of trigeminal neuralgia/nerve pain along (R) trigeminal nerve pathway & redness to (R) cheek. No vesicles to support clear Dx of herpes zoster.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: detected Ring (Tinnitus) in the evening of the Oct 10th 2nd Dose still exposed to symptoms
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Asthenia, Contusion, Diarrhoea, Dystonia
Clinical narrative: 9/9/2022 2:32pm  Shingrix Vaccine administered 9/9/2022 5:30pm I was lying on bed, reading. Sudden unusual aching and pain appeared on bottoms of both feet, ankles, then spreading up to both knees. Rubbing them did not aleviate discomfort. Walking around a bit seemed to help, but this strange aching returned as soon as I was sitting or lying down. (This symptom is still ongoing, however, and now added 2 episodes of foot cramping and foot dystonia which began on 9/27/2022) Numbness + tingling ongoing since 9/9/2022 9/11/2022 Sudden overall body weakness, followed by quick, stabbing, "electrical shock" pains along distal edge of right hand, followed by left hand about an hour later, This symptom continued while sleeping for 3 nights, Hand issue has since subsided. 9/13/2022 Sharp pain R temple followed by deep bruising pain behind right eye. Painful to touch and when moving eyes. Aspirin helped. 9/15/2022 Sclera of R eye became blood red still very painful move or touch. 9/17/2022 12:00pm Office visit with APRN. Suggested that Shingrix vaccine was creating autoimmune reaction related to having Sjogrens. Prescribed Gabapentin for nerve pain, which I have NOT taken (I'm very afraid of any medications). 9/17/2022 2:12pm Office visit with Ophthalmologist. Indicated that this was autoimmune reaction to Shingrix vaccine because of Sjogrens. Prescribed Prednisolone ACE 1% Eye drops. This medication quickly helped R eye. 9/18/2022 Same pain/redness sequence of symptoms began in left eye. Used Prednisolone Eye Drops to resolve. 9/24/2022 Sudden onset of body weakness and trembling (?) Hand "electrical shocks" and severe surprise "diarrhea". Rest and lots of water helped. 9/28/2022 Contact Dr (my rheumatologist for Sjogrens) to let him know of these Shingrix/Sjogrens developments.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Electric shock sensation, Eye pain, Hypoaesthesia, Muscle spasms, Neuralgia
Clinical narrative: 9/9/2022 2:32pm  Shingrix Vaccine administered 9/9/2022 5:30pm I was lying on bed, reading. Sudden unusual aching and pain appeared on bottoms of both feet, ankles, then spreading up to both knees. Rubbing them did not aleviate discomfort. Walking around a bit seemed to help, but this strange aching returned as soon as I was sitting or lying down. (This symptom is still ongoing, however, and now added 2 episodes of foot cramping and foot dystonia which began on 9/27/2022) Numbness + tingling ongoing since 9/9/2022 9/11/2022 Sudden overall body weakness, followed by quick, stabbing, "electrical shock" pains along distal edge of right hand, followed by left hand about an hour later, This symptom continued while sleeping for 3 nights, Hand issue has since subsided. 9/13/2022 Sharp pain R temple followed by deep bruising pain behind right eye. Painful to touch and when moving eyes. Aspirin helped. 9/15/2022 Sclera of R eye became blood red still very painful move or touch. 9/17/2022 12:00pm Office visit with APRN. Suggested that Shingrix vaccine was creating autoimmune reaction related to having Sjogrens. Prescribed Gabapentin for nerve pain, which I have NOT taken (I'm very afraid of any medications). 9/17/2022 2:12pm Office visit with Ophthalmologist. Indicated that this was autoimmune reaction to Shingrix vaccine because of Sjogrens. Prescribed Prednisolone ACE 1% Eye drops. This medication quickly helped R eye. 9/18/2022 Same pain/redness sequence of symptoms began in left eye. Used Prednisolone Eye Drops to resolve. 9/24/2022 Sudden onset of body weakness and trembling (?) Hand "electrical shocks" and severe surprise "diarrhea". Rest and lots of water helped. 9/28/2022 Contact Dr (my rheumatologist for Sjogrens) to let him know of these Shingrix/Sjogrens developments.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Paraesthesia, Tremor
Clinical narrative: 9/9/2022 2:32pm  Shingrix Vaccine administered 9/9/2022 5:30pm I was lying on bed, reading. Sudden unusual aching and pain appeared on bottoms of both feet, ankles, then spreading up to both knees. Rubbing them did not aleviate discomfort. Walking around a bit seemed to help, but this strange aching returned as soon as I was sitting or lying down. (This symptom is still ongoing, however, and now added 2 episodes of foot cramping and foot dystonia which began on 9/27/2022) Numbness + tingling ongoing since 9/9/2022 9/11/2022 Sudden overall body weakness, followed by quick, stabbing, "electrical shock" pains along distal edge of right hand, followed by left hand about an hour later, This symptom continued while sleeping for 3 nights, Hand issue has since subsided. 9/13/2022 Sharp pain R temple followed by deep bruising pain behind right eye. Painful to touch and when moving eyes. Aspirin helped. 9/15/2022 Sclera of R eye became blood red still very painful move or touch. 9/17/2022 12:00pm Office visit with APRN. Suggested that Shingrix vaccine was creating autoimmune reaction related to having Sjogrens. Prescribed Gabapentin for nerve pain, which I have NOT taken (I'm very afraid of any medications). 9/17/2022 2:12pm Office visit with Ophthalmologist. Indicated that this was autoimmune reaction to Shingrix vaccine because of Sjogrens. Prescribed Prednisolone ACE 1% Eye drops. This medication quickly helped R eye. 9/18/2022 Same pain/redness sequence of symptoms began in left eye. Used Prednisolone Eye Drops to resolve. 9/24/2022 Sudden onset of body weakness and trembling (?) Hand "electrical shocks" and severe surprise "diarrhea". Rest and lots of water helped. 9/28/2022 Contact Dr (my rheumatologist for Sjogrens) to let him know of these Shingrix/Sjogrens developments.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Vitamin D deficiency; This spontaneous case was reported by a patient and describes the occurrence of VITAMIN D DEFICIENCY (Vitamin D deficiency) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 15-Jun-2022, Gout since 22-Feb-2012, Hyperlipidemia since 22-Feb-2012 and Obesity (Body mass index more than or equal to 30). Concomitant products included ALLOPURINOL from 13-Jan-2020 to an unknown date for Gout, CHOLESTYRAMINE from 12-Jan-2021 to an unknown date for Hyperlipidemia, HCTZ from 10-Jun-2022 to an unknown date for Hypertension, VITAMIN D3 from 24-Feb-2022 to an unknown date for Vitamin D deficiency.    On 17-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VITAMIN D DEFICIENCY (Vitamin D deficiency). At the time of the report, VITAMIN D DEFICIENCY (Vitamin D deficiency) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies to medications, food and other products. It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  No treatment drug details was reported.   This case was linked to MOD-2022-629772, MOD-2022-610667 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Vitamin D deficiency; This spontaneous case was reported by a patient and describes the occurrence of VITAMIN D DEFICIENCY (Vitamin D deficiency) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 15-Jun-2022, Gout since 22-Feb-2012, Hyperlipidemia since 22-Feb-2012 and Obesity (Body mass index more than or equal to 30). Concomitant products included ALLOPURINOL from 13-Jan-2020 to an unknown date for Gout, CHOLESTYRAMINE from 12-Jan-2021 to an unknown date for Hyperlipidemia, HCTZ from 10-Jun-2022 to an unknown date for Hypertension, VITAMIN D3 from 24-Feb-2022 to an unknown date for Vitamin D deficiency.    On 17-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VITAMIN D DEFICIENCY (Vitamin D deficiency). At the time of the report, VITAMIN D DEFICIENCY (Vitamin D deficiency) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies to medications, food and other products. It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  No treatment drug details was reported.   This case was linked to MOD-2022-629772, MOD-2022-610667 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vitamin D deficiency; This spontaneous case was reported by a patient and describes the occurrence of VITAMIN D DEFICIENCY (Vitamin D deficiency) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 15-Jun-2022, Gout since 22-Feb-2012, Hyperlipidemia since 22-Feb-2012 and Obesity (Body mass index more than or equal to 30). Concomitant products included ALLOPURINOL from 13-Jan-2020 to an unknown date for Gout, CHOLESTYRAMINE from 12-Jan-2021 to an unknown date for Hyperlipidemia, HCTZ from 10-Jun-2022 to an unknown date for Hypertension, VITAMIN D3 from 24-Feb-2022 to an unknown date for Vitamin D deficiency.    On 17-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VITAMIN D DEFICIENCY (Vitamin D deficiency). At the time of the report, VITAMIN D DEFICIENCY (Vitamin D deficiency) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies to medications, food and other products. It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  No treatment drug details was reported.   This case was linked to MOD-2022-629772, MOD-2022-610667 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: Vitamin D deficiency; This spontaneous case was reported by a patient and describes the occurrence of VITAMIN D DEFICIENCY (Vitamin D deficiency) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 15-Jun-2022, Gout since 22-Feb-2012, Hyperlipidemia since 22-Feb-2012 and Obesity (Body mass index more than or equal to 30). Concomitant products included ALLOPURINOL from 13-Jan-2020 to an unknown date for Gout, CHOLESTYRAMINE from 12-Jan-2021 to an unknown date for Hyperlipidemia, HCTZ from 10-Jun-2022 to an unknown date for Hypertension, VITAMIN D3 from 24-Feb-2022 to an unknown date for Vitamin D deficiency.    On 17-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VITAMIN D DEFICIENCY (Vitamin D deficiency). At the time of the report, VITAMIN D DEFICIENCY (Vitamin D deficiency) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies to medications, food and other products. It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  No treatment drug details was reported.   This case was linked to MOD-2022-629772, MOD-2022-610667 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: It started of with a sore throat and mild fever of 101.8. I tested positive for COVID-19 at home. I did go to the urgent care and was prescribed Paxlovid. After 5-7 days I tested negative and then 4 days after that I tested positive for COVID-19 again. I just lost my sense of smell.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anosmia, COVID-19, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: It started of with a sore throat and mild fever of 101.8. I tested positive for COVID-19 at home. I did go to the urgent care and was prescribed Paxlovid. After 5-7 days I tested negative and then 4 days after that I tested positive for COVID-19 again. I just lost my sense of smell.
Sex: M
Vaccine: COVID19-2, FLUC4, COVID19, FLUC3
Symptoms: Chills, Dry mouth, Ear congestion, Fatigue, Myalgia
Clinical narrative: persistent and severe sore throat; dry mouth; Other Vaccine on Same date product: Flucelvax Quadravalent; Other Vaccine on Same date product: Flucelvax Quadravalent; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 23Sep2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose 3 (booster): unknown manufacture , Route of Administration: Intramuscular), administration date: Oct2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose 1; unknown manufacture), for COVID-19 Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Sep2022, outcome "unknown" and all described as "Other Vaccine on Same date product: Flucelvax Quadravalent"; DRY MOUTH (non-serious) with onset 24Sep2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 24Sep2022, outcome "not recovered", described as "persistent and severe sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, dry mouth.  Additional information: Patient administered Flucelvax Quadravalent in deltoid. Patient allergies, medical history was unknown and unknown if patient received any other medications in two weeks, and no other vaccine used in four weeks but used Flucelvax Quadravalent on same day on which covid vaccine was administered. Physician/patient reports persistent and severe sore throat following receipt of COVID19 bivalent booster and QIV flu vaccines associated with dry mouth. No fever or exudates. COVID19 antigen test negative x2. For oropharyngeal pain and dry mouth Taking ibuprofen with minimal relief. Not experienced COVID prior vaccination. Post vaccination nasal swab test result was negative.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19-2, FLUC4, COVID19, FLUC3
Symptoms: Oropharyngeal pain, SARS-CoV-2 test negative
Clinical narrative: persistent and severe sore throat; dry mouth; Other Vaccine on Same date product: Flucelvax Quadravalent; Other Vaccine on Same date product: Flucelvax Quadravalent; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 23Sep2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose 3 (booster): unknown manufacture , Route of Administration: Intramuscular), administration date: Oct2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose 1; unknown manufacture), for COVID-19 Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Sep2022, outcome "unknown" and all described as "Other Vaccine on Same date product: Flucelvax Quadravalent"; DRY MOUTH (non-serious) with onset 24Sep2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 24Sep2022, outcome "not recovered", described as "persistent and severe sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, dry mouth.  Additional information: Patient administered Flucelvax Quadravalent in deltoid. Patient allergies, medical history was unknown and unknown if patient received any other medications in two weeks, and no other vaccine used in four weeks but used Flucelvax Quadravalent on same day on which covid vaccine was administered. Physician/patient reports persistent and severe sore throat following receipt of COVID19 bivalent booster and QIV flu vaccines associated with dry mouth. No fever or exudates. COVID19 antigen test negative x2. For oropharyngeal pain and dry mouth Taking ibuprofen with minimal relief. Not experienced COVID prior vaccination. Post vaccination nasal swab test result was negative.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19-2, FLUC4, COVID19, FLUC3
Symptoms: Dry mouth, Off label use, Oropharyngeal pain, Product use issue, SARS-CoV-2 test
Clinical narrative: persistent and severe sore throat; dry mouth; Other Vaccine on Same date product: Flucelvax Quadravalent; Other Vaccine on Same date product: Flucelvax Quadravalent; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 23Sep2022 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose 3 (booster): unknown manufacture , Route of Administration: Intramuscular), administration date: Oct2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 2; unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose 1; unknown manufacture), for COVID-19 Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Sep2022, outcome "unknown" and all described as "Other Vaccine on Same date product: Flucelvax Quadravalent"; DRY MOUTH (non-serious) with onset 24Sep2022, outcome "not recovered"; OROPHARYNGEAL PAIN (non-serious) with onset 24Sep2022, outcome "not recovered", described as "persistent and severe sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, dry mouth.  Additional information: Patient administered Flucelvax Quadravalent in deltoid. Patient allergies, medical history was unknown and unknown if patient received any other medications in two weeks, and no other vaccine used in four weeks but used Flucelvax Quadravalent on same day on which covid vaccine was administered. Physician/patient reports persistent and severe sore throat following receipt of COVID19 bivalent booster and QIV flu vaccines associated with dry mouth. No fever or exudates. COVID19 antigen test negative x2. For oropharyngeal pain and dry mouth Taking ibuprofen with minimal relief. Not experienced COVID prior vaccination. Post vaccination nasal swab test result was negative.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Herpes zoster, Magnetic resonance imaging spinal, Spinal X-ray
Clinical narrative: Patient reports rib and mid back pain on the left progressing from mild to severe in a week after receiving the vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Musculoskeletal chest pain
Clinical narrative: Patient reports rib and mid back pain on the left progressing from mild to severe in a week after receiving the vaccine.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Angiocardiogram, Arthralgia, Back pain, Blood test, Computerised tomogram abnormal
Clinical narrative: massive inflammatory response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "massive inflammatory response". Clinical course: After getting 2nd vaccine in Mar2021 patient had a sever reaction that sent patient to the hospital. It was determined that body reacted with a massive inflammatory response. Still had significant effects and wanted to know if there was some information, patient could get in helping find someone that could evaluate and assist with possible remedies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Inflammation, Magnetic resonance imaging abnormal
Clinical narrative: massive inflammatory response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "massive inflammatory response". Clinical course: After getting 2nd vaccine in Mar2021 patient had a sever reaction that sent patient to the hospital. It was determined that body reacted with a massive inflammatory response. Still had significant effects and wanted to know if there was some information, patient could get in helping find someone that could evaluate and assist with possible remedies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Muscle tightness, Neck pain, Nervous system disorder, Pain, Scan myocardial perfusion
Clinical narrative: massive inflammatory response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "massive inflammatory response". Clinical course: After getting 2nd vaccine in Mar2021 patient had a sever reaction that sent patient to the hospital. It was determined that body reacted with a massive inflammatory response. Still had significant effects and wanted to know if there was some information, patient could get in helping find someone that could evaluate and assist with possible remedies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Sensory loss, Therapeutic nerve ablation, Ultrasound scan, X-ray
Clinical narrative: massive inflammatory response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "massive inflammatory response". Clinical course: After getting 2nd vaccine in Mar2021 patient had a sever reaction that sent patient to the hospital. It was determined that body reacted with a massive inflammatory response. Still had significant effects and wanted to know if there was some information, patient could get in helping find someone that could evaluate and assist with possible remedies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Inflammation
Clinical narrative: massive inflammatory response; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "massive inflammatory response". Clinical course: After getting 2nd vaccine in Mar2021 patient had a sever reaction that sent patient to the hospital. It was determined that body reacted with a massive inflammatory response. Still had significant effects and wanted to know if there was some information, patient could get in helping find someone that could evaluate and assist with possible remedies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Arthralgia, Compression garment application, Joint swelling, Pain in extremity
Clinical narrative: pain started in calf and moved more intensely at first into the ankle and foot. After a week or so pain lessened but kept moving from back of thigh to back of the knee, calf and ankle. After a few weeks, I noted that my right calf and ankle were swollen to an inch and half and inch respectively compared to the left leg.  I had concerns about blood clots but did not find any information of the being a known side effect of the vaccine.  I saw my PPC in October and presented the issue, but he did not think it to be a problem.  In May of this year i read a post from a fellow senior cyclist being treat for DVT. I called my PCP and at the appointment I again presented the symptoms. He referred me for an ultrasound and appointment with a hematologist. I met with him, and he prescribed 4 months of a blood thinner, and compression socks. The two interventions have provided relief from both the pain, and swelling.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: pain started in calf and moved more intensely at first into the ankle and foot. After a week or so pain lessened but kept moving from back of thigh to back of the knee, calf and ankle. After a few weeks, I noted that my right calf and ankle were swollen to an inch and half and inch respectively compared to the left leg.  I had concerns about blood clots but did not find any information of the being a known side effect of the vaccine.  I saw my PPC in October and presented the issue, but he did not think it to be a problem.  In May of this year i read a post from a fellow senior cyclist being treat for DVT. I called my PCP and at the appointment I again presented the symptoms. He referred me for an ultrasound and appointment with a hematologist. I met with him, and he prescribed 4 months of a blood thinner, and compression socks. The two interventions have provided relief from both the pain, and swelling.
Sex: U
Vaccine: COVID19-2
Symptoms: Facial pain, Pain in jaw, Trigeminal neuralgia
Clinical narrative: R facial pain jaw and cheek. Pain starting mild on Fri morning progressing to severe pain on Sat night slightly improving with tylenol and motrin.  Pain not improving, Dr appt on 9/15 and diagnosed with trigeminal neuralgia.  Started on tegretol 100mg 2 times a day increasing dose until pain improved to current dose of 300mg 3 times a day. Still requiring tylenol and motrin for break through pain.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaphylactic reaction, Anxiety, Blood test normal, Chest discomfort, Chest pain
Clinical narrative: 20 mon post shot Anaphlaxis,  flushing,  difficulty breathing, high blood pressure,  chest pains and chest pressure, shaking and feeling of doom
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Electrocardiogram, Flushing, Hypertension, Tremor
Clinical narrative: 20 mon post shot Anaphlaxis,  flushing,  difficulty breathing, high blood pressure,  chest pains and chest pressure, shaking and feeling of doom