chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adult strength influenza virus vaccine, Fluzone Quad, was administered to pediatric patients on a general floor. Several pediatrics received the wrong vaccine before the mistake was caught and corrected. Reporter's recommendations: Flag the pediatric vaccines with a bright color. The most accurate check point before administration would be to scan the drug product utilizing the barcode system before administration.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Syncope, Urticaria
Clinical narrative: Describe Event, Problem, or Product Use Error: Pfizer BioNTech vaccine for adult age 35 years. Patient received vaccine on 11/30/21. No ADR was noted during the 15 minute supervision period. 1 hour after vaccine administration, she had a near syncopal/syncopal episode. She was found to have hives and a headache. She was taken to emergency room. She was given oral tylenol and benadryl. She was discharged approximately 30 minutes later.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Palpitations, Sinus rhythm
Clinical narrative: J&J (Janssen) COVID-19 vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient received J&J COVID-19 vaccine and within 24 hours was admitted to hospital in early AM of 11/24/21 with palpitations and was found to be in atrial fibrillation with RVR. 24 hours later she as in sinus rhythm and was discharged from hospital.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Inflammation, Joint effusion, Viral infection
Clinical narrative: 6 year old received Pfizer Covid-19 Vaccine. Child could not walk 6 hours later. Ha to visit hospital. They diagnosed  it as Water on the Hip, due to inflammatory reaction to vaccine / virus. We consider this an adverse event to the recently approved children's vaccine. We are closely monitoring our child.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: First I got a large lymph node in my left arm pit. I wasn't able to close my arm the whole way. It started hurting in my left breast, the left side of my neck, left temple, and in my left eye. I always had migraines on my left side, but I wasn't having a migraine because no migraine medication would help. I started getting cluster headaches in my right eye to where it would wake me up. I went to urgent care and got a caudal shot. Then the next time I got oxygen with it. By the time I seen the neurologist it had been 45 days of constant migraines. They gave me a large dose of prednisone. On the 3rd or 4th day of the prednisone I was able to function again. As soon as I was done with prednisone it came back. After that they did Botox for migraines. I had that treatment twice now. Everything has been very expensive, and I have been having to come out of pocket. Every penny I made has been going to paying medical bills this year. I also had to get physical therapy for my neck twice a week. They sent me to an endocrinologist. All of my hair started falling out as well so they sent me to a dermatologist. I been getting body work done at another medical facility. Now they are starting me on medicine for fibromyalgia. My health has dramatically went down. I used to be a chef who owned my own business, but now I have been laying in bed unable to work or do anything. Now I am working a part time job and doing small catering. I am not back to my old self. I have chronic pain in my sacrum, buttocks, and coccyx. I haven't been able to sit for more than 20 minutes even on medication. I am now on Cymbalta and gabapentin. I felt like I was going to have to be on disability. This all came on after the second vaccination. I am still going to the physical therapist once a week now. I also have a hump on my back now in-between my shoulders at the base of my neck. The Botox helps but I still have pains. If I miss a medication I have muscle spasms.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Blood test, Breast pain, Cluster headache, Eye pain
Clinical narrative: First I got a large lymph node in my left arm pit. I wasn't able to close my arm the whole way. It started hurting in my left breast, the left side of my neck, left temple, and in my left eye. I always had migraines on my left side, but I wasn't having a migraine because no migraine medication would help. I started getting cluster headaches in my right eye to where it would wake me up. I went to urgent care and got a caudal shot. Then the next time I got oxygen with it. By the time I seen the neurologist it had been 45 days of constant migraines. They gave me a large dose of prednisone. On the 3rd or 4th day of the prednisone I was able to function again. As soon as I was done with prednisone it came back. After that they did Botox for migraines. I had that treatment twice now. Everything has been very expensive, and I have been having to come out of pocket. Every penny I made has been going to paying medical bills this year. I also had to get physical therapy for my neck twice a week. They sent me to an endocrinologist. All of my hair started falling out as well so they sent me to a dermatologist. I been getting body work done at another medical facility. Now they are starting me on medicine for fibromyalgia. My health has dramatically went down. I used to be a chef who owned my own business, but now I have been laying in bed unable to work or do anything. Now I am working a part time job and doing small catering. I am not back to my old self. I have chronic pain in my sacrum, buttocks, and coccyx. I haven't been able to sit for more than 20 minutes even on medication. I am now on Cymbalta and gabapentin. I felt like I was going to have to be on disability. This all came on after the second vaccination. I am still going to the physical therapist once a week now. I also have a hump on my back now in-between my shoulders at the base of my neck. The Botox helps but I still have pains. If I miss a medication I have muscle spasms.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Laboratory test, Lymphadenopathy, Migraine, Neck pain
Clinical narrative: First I got a large lymph node in my left arm pit. I wasn't able to close my arm the whole way. It started hurting in my left breast, the left side of my neck, left temple, and in my left eye. I always had migraines on my left side, but I wasn't having a migraine because no migraine medication would help. I started getting cluster headaches in my right eye to where it would wake me up. I went to urgent care and got a caudal shot. Then the next time I got oxygen with it. By the time I seen the neurologist it had been 45 days of constant migraines. They gave me a large dose of prednisone. On the 3rd or 4th day of the prednisone I was able to function again. As soon as I was done with prednisone it came back. After that they did Botox for migraines. I had that treatment twice now. Everything has been very expensive, and I have been having to come out of pocket. Every penny I made has been going to paying medical bills this year. I also had to get physical therapy for my neck twice a week. They sent me to an endocrinologist. All of my hair started falling out as well so they sent me to a dermatologist. I been getting body work done at another medical facility. Now they are starting me on medicine for fibromyalgia. My health has dramatically went down. I used to be a chef who owned my own business, but now I have been laying in bed unable to work or do anything. Now I am working a part time job and doing small catering. I am not back to my old self. I have chronic pain in my sacrum, buttocks, and coccyx. I haven't been able to sit for more than 20 minutes even on medication. I am now on Cymbalta and gabapentin. I felt like I was going to have to be on disability. This all came on after the second vaccination. I am still going to the physical therapist once a week now. I also have a hump on my back now in-between my shoulders at the base of my neck. The Botox helps but I still have pains. If I miss a medication I have muscle spasms.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, X-ray
Clinical narrative: First I got a large lymph node in my left arm pit. I wasn't able to close my arm the whole way. It started hurting in my left breast, the left side of my neck, left temple, and in my left eye. I always had migraines on my left side, but I wasn't having a migraine because no migraine medication would help. I started getting cluster headaches in my right eye to where it would wake me up. I went to urgent care and got a caudal shot. Then the next time I got oxygen with it. By the time I seen the neurologist it had been 45 days of constant migraines. They gave me a large dose of prednisone. On the 3rd or 4th day of the prednisone I was able to function again. As soon as I was done with prednisone it came back. After that they did Botox for migraines. I had that treatment twice now. Everything has been very expensive, and I have been having to come out of pocket. Every penny I made has been going to paying medical bills this year. I also had to get physical therapy for my neck twice a week. They sent me to an endocrinologist. All of my hair started falling out as well so they sent me to a dermatologist. I been getting body work done at another medical facility. Now they are starting me on medicine for fibromyalgia. My health has dramatically went down. I used to be a chef who owned my own business, but now I have been laying in bed unable to work or do anything. Now I am working a part time job and doing small catering. I am not back to my old self. I have chronic pain in my sacrum, buttocks, and coccyx. I haven't been able to sit for more than 20 minutes even on medication. I am now on Cymbalta and gabapentin. I felt like I was going to have to be on disability. This all came on after the second vaccination. I am still going to the physical therapist once a week now. I also have a hump on my back now in-between my shoulders at the base of my neck. The Botox helps but I still have pains. If I miss a medication I have muscle spasms.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Rash   Loss of appetite Concern over liver function Edema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Decreased appetite, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Rash   Loss of appetite Concern over liver function Edema
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema, Rash, Scan with contrast, Ultrasound abdomen
Clinical narrative: Rash   Loss of appetite Concern over liver function Edema
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Epistaxis, Immunoglobulin therapy, Mouth haemorrhage, Petechiae
Clinical narrative: Severe thrombocytopenia without thrombosis, ultimately diagnosis with immune thrombocytopenia (ITP), diagnosed after presenting with petechiae and platelet count of 3 on 5/3/21, after receiving 1st dose of vaccine on 4/1 without incident and second dose of vaccine on 4/22/21. Prior platelet count normal.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased
Clinical narrative: Severe thrombocytopenia without thrombosis, ultimately diagnosis with immune thrombocytopenia (ITP), diagnosed after presenting with petechiae and platelet count of 3 on 5/3/21, after receiving 1st dose of vaccine on 4/1 without incident and second dose of vaccine on 4/22/21. Prior platelet count normal.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow normal, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Severe thrombocytopenia without thrombosis, ultimately diagnosis with immune thrombocytopenia (ITP), diagnosed after presenting with petechiae and platelet count of 3 on 5/3/21, after receiving 1st dose of vaccine on 4/1 without incident and second dose of vaccine on 4/22/21. Prior platelet count normal.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Musculoskeletal stiffness, Myalgia, Nausea, Viral test
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cognitive disorder, Computerised tomogram head, Fatigue, Headache, Impaired work ability
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging head, Memory impairment, Meningitis viral
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Disability, Headache, Impaired work ability, Incomplete course of vaccination
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Meningitis aseptic, Musculoskeletal stiffness, Nausea, SARS-CoV-2 test negative
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sick leave, Visual impairment, Vomiting
Clinical narrative: Patient presented to the ED on 3/18/21 with 4 days of moderate severe intensity her frontal headaches nausea vomiting diarrhea malaise stiff neck visual disturbances. Patient reported she tipped to negative Covid test since onset of her symptoms as she also received a Covid vaccination 5 days ago. ID Dr. suspects aseptic meningitis due to Moderna vaccine (received COVID vaccine 5 day prior to presentation).  Treated with dexamethasone. Discharged from hospital to home on 3/23/21. Requires follow up with infectious disease and neurology specialists as outpatient and required leave of absense from work on short term disability. Patient advised by ID Dr. not to receive further COVID vaccines or influenza vaccines.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Muscular weakness, Nervousness
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional). The reporter is the patient. A 77-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 06Feb2021 16:30 (Lot number: EL9265) at the age of 77 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: patient is on high blood pressure medication.; "chemo" (unspecified if ongoing), notes: five years ago. Concomitant medication included: FLU VACCINE VII taken for immunisation. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "recovered", described as "her legs just melted"; HYPERSOMNIA (non-serious), outcome "recovered", described as "slept a lot"; ASTHENIA (non-serious), outcome "recovered", described as "weak"; ELECTROLYTE IMBALANCE (non-serious), outcome "recovered", described as "get the electrolytes back". Therapeutic measures were taken as a result of muscular weakness, hypersomnia, asthenia, electrolyte imbalance. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electrolyte imbalance, Hypersomnia, Muscular weakness
Clinical narrative: This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional). The reporter is the patient. A 77-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 06Feb2021 16:30 (Lot number: EL9265) at the age of 77 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: patient is on high blood pressure medication.; "chemo" (unspecified if ongoing), notes: five years ago. Concomitant medication included: FLU VACCINE VII taken for immunisation. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "recovered", described as "her legs just melted"; HYPERSOMNIA (non-serious), outcome "recovered", described as "slept a lot"; ASTHENIA (non-serious), outcome "recovered", described as "weak"; ELECTROLYTE IMBALANCE (non-serious), outcome "recovered", described as "get the electrolytes back". Therapeutic measures were taken as a result of muscular weakness, hypersomnia, asthenia, electrolyte imbalance. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Death, Influenza like illness
Clinical narrative: Decedent was found unresponsive 2 days after he received 1st dose of Moderna vaccine (unknown lot number). Additional tests show presence of lymphocytic myocarditis.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Laboratory test, Myocarditis, Unresponsive to stimuli
Clinical narrative: Decedent was found unresponsive 2 days after he received 1st dose of Moderna vaccine (unknown lot number). Additional tests show presence of lymphocytic myocarditis.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Impaired work ability, Vertigo
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: EW0179) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATIVAN; METHYLPREDNISOLONE.The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "lightheadedness dizzyness"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Vitamins used as concomitant medication. Duration of events was 1 week.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: EW0179) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATIVAN; METHYLPREDNISOLONE.The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "lightheadedness dizzyness"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "brain fog". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Vitamins used as concomitant medication. Duration of events was 1 week.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis, Computerised tomogram abnormal, Fatigue
Clinical narrative: Appendicitis; Heavy vaginal bleeding; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Aug2021 20:00 (Lot number: Fa7485) at the age of 36 years as DOSE 1, SINGLE for COVID-19 immunisation, in pharmacy or drug store. No other vaccine in four weeks. Relevant medical history included: "Sulfa allergies" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 16Aug2021, outcome "recovered with sequelae", described as "Appendicitis"; VAGINAL HAEMORRHAGE (hospitalization) with onset 11Aug2021 21:00, outcome "recovered with sequelae", described as "Heavy vaginal bleeding". The patient was hospitalized for appendicitis, vaginal haemorrhage (hospitalization duration: 2 days). The events "appendicitis" and "heavy vaginal bleeding" were evaluated at the physician office visit and emergency room visit. Clinical course: heavy vaginal bleeding 24 hours after vaccination, loss of appetite and abdominal pain 5 days post vaccination, appendicitis diagnosed 6th day post vaccination, appendectomy day 7 post vaccine. Therapeutic measures were taken as a result of appendicitis and included treatment with appendectomy. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Scan with contrast, Vaginal haemorrhage
Clinical narrative: Appendicitis; Heavy vaginal bleeding; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Aug2021 20:00 (Lot number: Fa7485) at the age of 36 years as DOSE 1, SINGLE for COVID-19 immunisation, in pharmacy or drug store. No other vaccine in four weeks. Relevant medical history included: "Sulfa allergies" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 16Aug2021, outcome "recovered with sequelae", described as "Appendicitis"; VAGINAL HAEMORRHAGE (hospitalization) with onset 11Aug2021 21:00, outcome "recovered with sequelae", described as "Heavy vaginal bleeding". The patient was hospitalized for appendicitis, vaginal haemorrhage (hospitalization duration: 2 days). The events "appendicitis" and "heavy vaginal bleeding" were evaluated at the physician office visit and emergency room visit. Clinical course: heavy vaginal bleeding 24 hours after vaccination, loss of appetite and abdominal pain 5 days post vaccination, appendicitis diagnosed 6th day post vaccination, appendectomy day 7 post vaccine. Therapeutic measures were taken as a result of appendicitis and included treatment with appendectomy. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Vaginal haemorrhage
Clinical narrative: Appendicitis; Heavy vaginal bleeding; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient (unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Aug2021 20:00 (Lot number: Fa7485) at the age of 36 years as DOSE 1, SINGLE for COVID-19 immunisation, in pharmacy or drug store. No other vaccine in four weeks. Relevant medical history included: "Sulfa allergies" (unspecified if ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The following information was reported: APPENDICITIS (hospitalization, medically significant) with onset 16Aug2021, outcome "recovered with sequelae", described as "Appendicitis"; VAGINAL HAEMORRHAGE (hospitalization) with onset 11Aug2021 21:00, outcome "recovered with sequelae", described as "Heavy vaginal bleeding". The patient was hospitalized for appendicitis, vaginal haemorrhage (hospitalization duration: 2 days). The events "appendicitis" and "heavy vaginal bleeding" were evaluated at the physician office visit and emergency room visit. Clinical course: heavy vaginal bleeding 24 hours after vaccination, loss of appetite and abdominal pain 5 days post vaccination, appendicitis diagnosed 6th day post vaccination, appendectomy day 7 post vaccine. Therapeutic measures were taken as a result of appendicitis and included treatment with appendectomy. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was not 18 years old at the time of the administration. There were no adverse signs/symptoms and therefore no treatment required.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was not 18 years old at the time of the administration. There were no adverse signs/symptoms and therefore no treatment required.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Malaise, Musculoskeletal stiffness
Clinical narrative: flu like symptoms; body/skin tender to touch; body/skin tender to touch; I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 22Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 27Jan2021, for COVID-19 immunisation, reaction(s): "normal reactions". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms"; PAIN (non-serious), PAIN OF SKIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body/skin tender to touch"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "neck felt like she slept on it wrong. Caller stated, "like it was stiff."". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was asking if she can use antipyretics before or after vaccination with BNT162B2 and also wants to know if anyone reported about something happening with their 4th cranial nerve. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Product administered at inappropriate site
Clinical narrative: flu like symptoms; body/skin tender to touch; body/skin tender to touch; I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 22Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 27Jan2021, for COVID-19 immunisation, reaction(s): "normal reactions". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms"; PAIN (non-serious), PAIN OF SKIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body/skin tender to touch"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "neck felt like she slept on it wrong. Caller stated, "like it was stiff."". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was asking if she can use antipyretics before or after vaccination with BNT162B2 and also wants to know if anyone reported about something happening with their 4th cranial nerve. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Influenza like illness, Musculoskeletal stiffness, Pain
Clinical narrative: flu like symptoms; body/skin tender to touch; body/skin tender to touch; I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 22Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 27Jan2021, for COVID-19 immunisation, reaction(s): "normal reactions". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms"; PAIN (non-serious), PAIN OF SKIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body/skin tender to touch"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "neck felt like she slept on it wrong. Caller stated, "like it was stiff."". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was asking if she can use antipyretics before or after vaccination with BNT162B2 and also wants to know if anyone reported about something happening with their 4th cranial nerve. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain of skin
Clinical narrative: flu like symptoms; body/skin tender to touch; body/skin tender to touch; I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 22Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 27Jan2021, for COVID-19 immunisation, reaction(s): "normal reactions". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms"; PAIN (non-serious), PAIN OF SKIN (non-serious) all with onset 2021, outcome "unknown" and all described as "body/skin tender to touch"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "I felt terrible. At night I had on a long sleeve night gown and robe and was wrapped up with blankets. My heart raced like no one business. My heart rate was 100 not long but for a few hours"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "neck felt like she slept on it wrong. Caller stated, "like it was stiff."". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was asking if she can use antipyretics before or after vaccination with BNT162B2 and also wants to know if anyone reported about something happening with their 4th cranial nerve. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Herpes virus infection, Herpes zoster, Laboratory test, Pain in extremity
Clinical narrative: could barely walk; lost 44 pounds since that shot; Muscle wasting is occuring.; Rheumatoid arthritis; shooting pain in his feet and lower legs; pain; outbreak of herpes/shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0151) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history, no known allergies. Concomitant medication included: TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose administration date: 19Mar2021, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (disability) with onset 14Apr2021 03:00, outcome "not recovered", described as "outbreak of herpes/shingles"; PAIN IN EXTREMITY (disability) with onset 23Apr2021, outcome "not recovered", described as " shooting pain in his feet and lower legs"; PAIN (disability) with onset 16Apr2021, outcome "not recovered", described as "pain"; GAIT DISTURBANCE (disability), outcome "not recovered", described as "could barely walk"; WEIGHT DECREASED (disability), outcome "not recovered", described as "lost 44 pounds since that shot"; MUSCLE ATROPHY (disability), outcome "not recovered", described as "Muscle wasting was occurring."; RHEUMATOID ARTHRITIS (disability), outcome "not recovered", described as "Rheumatoid arthritis". The events "outbreak of herpes/shingles", " shooting pain in his feet and lower legs", "pain", "could barely walk", "lost 44 pounds since that shot", "muscle wasting is occurring." and "rheumatoid arthritis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: weight: lost 44 pounds. Therapeutic measures were not taken as a result of herpes zoster, pain in extremity, pain, gait disturbance, weight decreased, muscle atrophy, rheumatoid arthritis. Clinical course: 5 days after the vaccine (14Apr2021 03:00) the patient had an outbreak of herpes, two week later (23Apr2021) shooting pain in his feet and lower legs, few more weeks shingles then another bout of shingles. The patient had been in pain since 1 week (16Apr2021) after second dose. He could barely walk, lost 44 pounds since that shot. Muscle wasting was occurring. He had to see a neurologist who has refereed him to a rheumatologist. Can't even get an appointment. Never had rheumatoid arthritis (RA) before this shot. He was an active man who exercised everyday. No COVID tested post vaccination. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rheumatoid arthritis, Rheumatoid factor increased
Clinical narrative: could barely walk; lost 44 pounds since that shot; Muscle wasting is occuring.; Rheumatoid arthritis; shooting pain in his feet and lower legs; pain; outbreak of herpes/shingles; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0151) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history, no known allergies. Concomitant medication included: TYLENOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose administration date: 19Mar2021, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (disability) with onset 14Apr2021 03:00, outcome "not recovered", described as "outbreak of herpes/shingles"; PAIN IN EXTREMITY (disability) with onset 23Apr2021, outcome "not recovered", described as " shooting pain in his feet and lower legs"; PAIN (disability) with onset 16Apr2021, outcome "not recovered", described as "pain"; GAIT DISTURBANCE (disability), outcome "not recovered", described as "could barely walk"; WEIGHT DECREASED (disability), outcome "not recovered", described as "lost 44 pounds since that shot"; MUSCLE ATROPHY (disability), outcome "not recovered", described as "Muscle wasting was occurring."; RHEUMATOID ARTHRITIS (disability), outcome "not recovered", described as "Rheumatoid arthritis". The events "outbreak of herpes/shingles", " shooting pain in his feet and lower legs", "pain", "could barely walk", "lost 44 pounds since that shot", "muscle wasting is occurring." and "rheumatoid arthritis" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: weight: lost 44 pounds. Therapeutic measures were not taken as a result of herpes zoster, pain in extremity, pain, gait disturbance, weight decreased, muscle atrophy, rheumatoid arthritis. Clinical course: 5 days after the vaccine (14Apr2021 03:00) the patient had an outbreak of herpes, two week later (23Apr2021) shooting pain in his feet and lower legs, few more weeks shingles then another bout of shingles. The patient had been in pain since 1 week (16Apr2021) after second dose. He could barely walk, lost 44 pounds since that shot. Muscle wasting was occurring. He had to see a neurologist who has refereed him to a rheumatologist. Can't even get an appointment. Never had rheumatoid arthritis (RA) before this shot. He was an active man who exercised everyday. No COVID tested post vaccination. No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.