chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 100.5.   Nausea, vomiting, headache and left arm pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Lymphadenopathy, Mouth swelling, Oral pain, Pyrexia
Clinical narrative: My mouth has developed swollen, red, tender gums and also some areas of roof of mouth. Behind front upper teeth is the worst. Also on  inside of right premolars area is very tender and sore. A slight bit of tenderness and swelling on inside of right cheek where premolars are also sore. Inside upper lip in top most center area is also red and swollen and extends down front to teeth. I took some ibuprofen but it did nothing. I just now took two Benadryl and it might be feeling a slight bit of improvement. First symptoms started yesterday evening around 5pm.  This morning symptoms became more pronounced. And now at 8:30pm it feels much higher level of discomfort.  My left lymph node under mandible is a bit swollen too. And around 3pm I felt like I had a slight fever but didn?t take temp. I Otherwise feel fine and have no other medical issues occurring.   When I was 10 I was diagnosed as having PCN allergy. I recall something like this happening about five days after I was prescribed. Something like this also happened after taking Sulfa antibiotic but it was at back of throat about 4 days after first administration. That was in 2015.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: My mouth has developed swollen, red, tender gums and also some areas of roof of mouth. Behind front upper teeth is the worst. Also on  inside of right premolars area is very tender and sore. A slight bit of tenderness and swelling on inside of right cheek where premolars are also sore. Inside upper lip in top most center area is also red and swollen and extends down front to teeth. I took some ibuprofen but it did nothing. I just now took two Benadryl and it might be feeling a slight bit of improvement. First symptoms started yesterday evening around 5pm.  This morning symptoms became more pronounced. And now at 8:30pm it feels much higher level of discomfort.  My left lymph node under mandible is a bit swollen too. And around 3pm I felt like I had a slight fever but didn?t take temp. I Otherwise feel fine and have no other medical issues occurring.   When I was 10 I was diagnosed as having PCN allergy. I recall something like this happening about five days after I was prescribed. Something like this also happened after taking Sulfa antibiotic but it was at back of throat about 4 days after first administration. That was in 2015.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Rash, Skin exfoliation
Clinical narrative: PEELING HANDS/FEET, DIFFUSE GENERALIZED RASH.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electric shock sensation, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Fever of 100.4, chills, occasional body sensations like a jolt of electricity (as if weaning off of an anti-depressant)started at 2:00 pm of day 2 and lasted until early morning of day 3, stiff neck/muscle ache on 4/7/21
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling,  itchy, rash at injection sit on left arm
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Pt received vaccine and then began to feel nauseated and fatigue. Pt laid down on a cot, with small sips of water and less than 15 minutes later patient said the symptoms resolved.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Tired, aches, felt like I had a fever, even though I did not
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Inflammation, Injection site pain, Malaise
Clinical narrative: 7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided.  Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pyrexia
Clinical narrative: 7 hours from vaccine, my heart started palpitating and I started feeling sick. I got in my car to go home from a friends house and started severe chills and called Doctor for fear of heart attack. They told me to go to ER. I continued driving home. Chills got worse. I got in shower with heater on and chills persisted. Drank coconut water and heart palpitations resided.  Got in bed and fever spiked to 102 and every bone was inflamed in pain. Nyquil did nothing. After a few hours of severe and unbearable pain I called ER. Headed over to ER at 3:00 a.m. and sat in parking lot. Fever broke at 3:00 a.m. which was hour 14 after vaccine. Other than severe nausea, pain calmed down. Drove home with Tylenol. Took 1,000 mg and finally rested at 4:00 a.m. Woke up at 8:00 a.m. with nausea but pain gone. 24 hours from vaccine, most of the reaction gone. 48 hours out body normal but pain in injection site.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Nausea, headache, chills, fatigue, diarrhea, wheezing
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Nausea, headache, chills, fatigue, diarrhea, wheezing
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Petechiae, Rash
Clinical narrative: Moderna COVID-19 Vaccine EUA March 22 in the evening a red, itchy, painful and burning sensation began around the injection site. The area around the injection site also turned red (it was  approximately 1x2 inches),  Ice was applied at time of initial symptoms. Symptoms seemed to subside within 48 hours, however I have been continuing to have moments of pain and itchiness flare up including today April 8, 2021.  I have also had an ovoid area of what appears to be a rash or petechiae on the underside of my left forearm near the wrist
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall, Fatigue, Limb discomfort, Pyrexia
Clinical narrative: Cement like feeling in limbs, fever, exhaustion, sleep so deep family worried about consciousness, vertigo leading to falling, confusion
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Cement like feeling in limbs, fever, exhaustion, sleep so deep family worried about consciousness, vertigo leading to falling, confusion
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Urticaria
Clinical narrative: Chills, fatigue and hives
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Crying, Suicidal ideation
Clinical narrative: Almost immediate severe suicidal thoughts. Within hours.  Crying.  Anger.  Inability to control thoughts of self-harm and crying.  I thought I was contacting a help line by clicking this link, but it?s just a long form.  It?s upsetting.   So many mental health issues since getting COVID.  I hope everyone reading this is well.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Myalgia, Palpitations
Clinical narrative: Fever, chills, muscle aches, hip joint pain, dizziness, vomiting, fainting, high heart rate
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Fever, chills, muscle aches, hip joint pain, dizziness, vomiting, fainting, high heart rate
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Fever, headache, body aches. Site of injection very red and hot and swollen as large as a baseball
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, headache, body aches. Site of injection very red and hot and swollen as large as a baseball
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Pain, Pyrexia, Thirst
Clinical narrative: Dry mouth, excessive thirst within the first hour post administration which persisted for about eight hours. About twelve hours post administration developed widespread, severe aches and a fever that persisted overnight into the following day. 36 hours post administration moderate aches and chills with no measurable fever.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: I received the vaccine on April 6. At the time of receiving the vaccine I began to feel numbness in the tip of the tongue, lips and central incisors, on April 7, the day after receiving the vaccine I began to feel numbness in the small fingers of both hands. Today, April 8, the numbness of the lips and the numbness and tingling still persist in all the fingers of the hands, especially the little fingers
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient presented to pharmacy center stating that she was having an adverse event shortly after vaccination. She sat down & reported lip swelling, facial swelling, facial tingling from chin -> ears. She was administered Benadryl x2 tabs & sips of H20. 911 was called & EMS took her out for further evaluation.
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Lip swelling, Paraesthesia, Swelling face
Clinical narrative: Patient presented to pharmacy center stating that she was having an adverse event shortly after vaccination. She sat down & reported lip swelling, facial swelling, facial tingling from chin -> ears. She was administered Benadryl x2 tabs & sips of H20. 911 was called & EMS took her out for further evaluation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eye contusion, Pyrexia, Syncope
Clinical narrative: PATIENT FAINTED IN BATHROOM (Fainting, Syncope) FAINTING RESULTED IN BLACK EYE (Black eye, Eye contusion) CHILLS (Chills, Chills) FEVER (Fever, Pyrexia) This spontaneous report received from a patient via a company representative concerned a patient of unknown sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On the night of vaccination, 05-MAR-2021, the patient had chills and fever. The following day, the patient fainted in the bathroom which resulted in a black eye. At the time of this report, there were no reports of the previously mentioned adverse events. The patient would get a head x-ray to make sure everything was okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from patient fainted in bathroom, chills, and fever on MAR-2021, and the outcome of fainting resulted in black eye was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and chills, fever, patient fainted in bathroom was related. The reporter causality between covid-19 vaccine ad26.cov2.s and fainting resulted in black eye was possible. Company causality between covid-19 vaccine ad26.cov2.s and chills, fever, patient fainted in bathroom, fainting resulted in black eye was possible. This report was serious (Other Medically Important Condition).  Additional information was received from telephone log on 22-MAR-2021. This report contained no new regulatory relevant information. Telephone call was placed reached generic voice message. No message left.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Presyncope
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the patient experienced a very adverse reaction. According to the physicians at the site, it was vasovagal episode. Ultimately, the patient had to go to the ER because of atrial fibrillation. If interested, the patient would be happy to speak about it, and share the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The out come of the vasovagal episode and atrial fibrillation was not reported. the repot was serious (Other Medically Important Condition). Version (1) created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Reporter causality statement was removed from narrative, vaccine type and vaccination site were removed.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the patient experienced a very adverse reaction. According to the physicians at the site, it was vasovagal episode. Ultimately, the patient had to go to the ER because of atrial fibrillation. If interested, the patient would be happy to speak about it, and share the experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The out come of the vasovagal episode and atrial fibrillation was not reported. the repot was serious (Other Medically Important Condition). Version (1) created to amend previously reported information on 10-Mar-2021. Upon review the following information was amended: Reporter causality statement was removed from narrative, vaccine type and vaccination site were removed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, weight and medical history were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov.2 (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 05-Mar-2021 to Left Deltoids for prophylactic vaccination. No concomitant medications were reported.  The patient received PCR test the next day (on 06-Mar-2021) which came back positive for COVID 19. He reported mild fever as his only symptom. On 07-Mar-2021, the subject experienced clinically confirm COVID 19 diagnosis. The action taken with covid-19 vaccine ad26cov2.s was not applicable. The outcome of the clinically confirm COVID19 diagnosis, mild fever and PCR test positive for COVID-19 was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000172118. The suspected product quality complaint has been confirmed to be this record indicated a positive PCR test result the day after the patient received the vaccine, therefore there was no time between the vaccine administration and the PCR test for the vaccine to be effective. So it was confirmed no product quality complaint (PQC) was identified within the reported complaint case. Case is approved for void, based on the PQC evaluation/investigation performed. Additional information was received from central complaint vigilance on 09-Mar-2021 following information was updated and incorporated into case narrative: investigational results
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, weight and medical history were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov.2 (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 05-Mar-2021 to Left Deltoids for prophylactic vaccination. No concomitant medications were reported.  The patient received PCR test the next day (on 06-Mar-2021) which came back positive for COVID 19. He reported mild fever as his only symptom. On 07-Mar-2021, the subject experienced clinically confirm COVID 19 diagnosis. The action taken with covid-19 vaccine ad26cov2.s was not applicable. The outcome of the clinically confirm COVID19 diagnosis, mild fever and PCR test positive for COVID-19 was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000172118. The suspected product quality complaint has been confirmed to be this record indicated a positive PCR test result the day after the patient received the vaccine, therefore there was no time between the vaccine administration and the PCR test for the vaccine to be effective. So it was confirmed no product quality complaint (PQC) was identified within the reported complaint case. Case is approved for void, based on the PQC evaluation/investigation performed. Additional information was received from central complaint vigilance on 09-Mar-2021 following information was updated and incorporated into case narrative: investigational results
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Feeling cold, Musculoskeletal chest pain, Tremor
Clinical narrative: SHAKINESS (LIKE SEIZURE) (Shaking, Tremor) CHEST AND RIBS BEING PAINFUL (Rib pain, Musculoskeletal chest pain) FEELING COLD (Feeling Cold, Feeling Cold) FEELING AWFUL (Feels awful, Feeling abnormal) This spontaneous report received from a patient and concerned a patient of unspecified age and sex.  The patient's weight, height, and medical history were not reported.   The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported. On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, was recovering from feeling cold, and feeling awful. This report was serious (Other Medically Import Condition).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Feeling abnormal, Feeling cold, Musculoskeletal chest pain, Seizure like phenomena
Clinical narrative: SHAKINESS (LIKE SEIZURE) (Shaking, Tremor) CHEST AND RIBS BEING PAINFUL (Rib pain, Musculoskeletal chest pain) FEELING COLD (Feeling Cold, Feeling Cold) FEELING AWFUL (Feels awful, Feeling abnormal) This spontaneous report received from a patient and concerned a patient of unspecified age and sex.  The patient's weight, height, and medical history were not reported.   The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported. On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, was recovering from feeling cold, and feeling awful. This report was serious (Other Medically Import Condition).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: SHAKINESS (LIKE SEIZURE) (Shaking, Tremor) CHEST AND RIBS BEING PAINFUL (Rib pain, Musculoskeletal chest pain) FEELING COLD (Feeling Cold, Feeling Cold) FEELING AWFUL (Feels awful, Feeling abnormal) This spontaneous report received from a patient and concerned a patient of unspecified age and sex.  The patient's weight, height, and medical history were not reported.   The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported. On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, was recovering from feeling cold, and feeling awful. This report was serious (Other Medically Import Condition).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was underage the approved age for this vaccine. No adverse reactions have been reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Dysphagia, Dyspnoea
Clinical narrative: difficulting breathing Narrative: Patient contacted telephone triage nurse today requesting appt with provider for c/o, "I got a covid vaccine 3 weeks ago, I'm not sure if I'm having a reaction to the vaccine or what, but I cannot breathe and it's hard to swallow." Patient states right after he received the vaccine he developed difficulty swallowing, "I can't even eat anything, it just won't go down - the only thing I can eat is pudding." States his tongue has been "double the size it should be" since he received the covid vaccine. No worse today than it has been, "just not getting better and I still can't eat." No speech difficulties during conversation (enunciating words properly). Pt is now c/o difficulty breathing, "I just feel short of breath." States he noticed the SOB yesterday, worse today. +CP with both cough and deep inspiration. Some mild wheezing, chills. Cough is nonproductive. No conversational dyspnea or cough during conversation. Recommended local ER now, states he will have family member drive him to ER now.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia, Immediate post-injection reaction, Painful respiration, Swollen tongue, Wheezing
Clinical narrative: difficulting breathing Narrative: Patient contacted telephone triage nurse today requesting appt with provider for c/o, "I got a covid vaccine 3 weeks ago, I'm not sure if I'm having a reaction to the vaccine or what, but I cannot breathe and it's hard to swallow." Patient states right after he received the vaccine he developed difficulty swallowing, "I can't even eat anything, it just won't go down - the only thing I can eat is pudding." States his tongue has been "double the size it should be" since he received the covid vaccine. No worse today than it has been, "just not getting better and I still can't eat." No speech difficulties during conversation (enunciating words properly). Pt is now c/o difficulty breathing, "I just feel short of breath." States he noticed the SOB yesterday, worse today. +CP with both cough and deep inspiration. Some mild wheezing, chills. Cough is nonproductive. No conversational dyspnea or cough during conversation. Recommended local ER now, states he will have family member drive him to ER now.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fall, Heart rate increased, Muscular weakness
Clinical narrative: weakness, falling  Narrative: Patient is a 76yo male who was contacted by phone and reports  that on Friday afternoon March 13th felt weak and fell, went to ER after falling 5x,  also felt muscle weakness 'like I had rheumatic fever when I was a kid'; daughter  came home and took him to local ER. Received 2nd of 2 part  covid vaccine on March 11th at Health Care Center, thought to have reaction to vaccine. Next  morning felt mild temp and then symptoms progressed to the point of weakness in  legs causing him to fall; rapid heart rate 100-140s noted in hospital, back to  normal during stay. Discharged from hospital on Sunday March 14th 2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Headache, Hemiparesis, Magnetic resonance imaging normal
Clinical narrative: LUE and LLE weakness
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Hypertension, Impaired work ability, Nausea
Clinical narrative: Fever, NauseaVomiting, HYPERtension, Angina, Tachycardia, Chest pain radiating down L arm with hypertensive issues at  199/109. Narrative: Employee reports was taken to hospital and stayed for 2 days. Missed 2 days of work due to symptoms.  Other Relevant History:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vomiting
Clinical narrative: Fever, NauseaVomiting, HYPERtension, Angina, Tachycardia, Chest pain radiating down L arm with hypertensive issues at  199/109. Narrative: Employee reports was taken to hospital and stayed for 2 days. Missed 2 days of work due to symptoms.  Other Relevant History:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow abnormal, Haemorrhagic diathesis, Immune thrombocytopenia, Immunoglobulin therapy, Megakaryocytes normal
Clinical narrative: Narrative:  65yr male with a history of CLL (stable disease on most recent CT) followed by Hematology service and was on observation without active treatment. PLT prior to Moderna #1 (2/19/21) and Moderna #2 (3/19/21) was WNL (238, date 1/27/2021). Within 2 days of Moderna #2 reports to hematology bleeding easily and PLT count was obtained <2 (3/24/21). Patient was directly admitted to the hospital for ITP (common CLL complication though one case report of IPT post vaccination). Bone marrow biopsy done on 3/31/21 showed 40% CLL cells with low normal megakaryocytes on preliminary read. ITP Therapy: Continues on prednisone 1mg/kg, s/p IVIG 3/25-3/28, rituximab-pvvr on 4/1 (4 weekly doses) started MMF and TXA 650mg TID on 4/2 for ongoing mucosal bleeding and low PLT (<2), then eltrombopag 50mg daily started on 4/3 (PLT <2). PLT count on 4/6 <2 and Surgical team consulted for consideration of splenectomy. On 4/7 PLT 5000 ITP is refractory to steroids and IVIG, with ongoing severe thrombocytopenia on rituximab, MMF, eltrombopag. Surgical Consult: ITP in light of multiple medical treatments, a laparoscopic, possible open, splenectomy is warranted. Surgery is planned for 7:30AM on Thursday, 4/8/2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Mucosal haemorrhage, Platelet count decreased
Clinical narrative: Narrative:  65yr male with a history of CLL (stable disease on most recent CT) followed by Hematology service and was on observation without active treatment. PLT prior to Moderna #1 (2/19/21) and Moderna #2 (3/19/21) was WNL (238, date 1/27/2021). Within 2 days of Moderna #2 reports to hematology bleeding easily and PLT count was obtained <2 (3/24/21). Patient was directly admitted to the hospital for ITP (common CLL complication though one case report of IPT post vaccination). Bone marrow biopsy done on 3/31/21 showed 40% CLL cells with low normal megakaryocytes on preliminary read. ITP Therapy: Continues on prednisone 1mg/kg, s/p IVIG 3/25-3/28, rituximab-pvvr on 4/1 (4 weekly doses) started MMF and TXA 650mg TID on 4/2 for ongoing mucosal bleeding and low PLT (<2), then eltrombopag 50mg daily started on 4/3 (PLT <2). PLT count on 4/6 <2 and Surgical team consulted for consideration of splenectomy. On 4/7 PLT 5000 ITP is refractory to steroids and IVIG, with ongoing severe thrombocytopenia on rituximab, MMF, eltrombopag. Surgical Consult: ITP in light of multiple medical treatments, a laparoscopic, possible open, splenectomy is warranted. Surgery is planned for 7:30AM on Thursday, 4/8/2021.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: 2 days P vaccine pt called in complaining of loss of leg ins-  Flu T PCP/ post vaste
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paralysis
Clinical narrative: GRADUAL WEEKNESS IN LEGS, THEN PARALYSIS, HOSPITALIZATION, PHYSICAL THERAPY. DRS PREDICT 2 MONTHS OF REHAB.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Feminisation acquired
Clinical narrative: ABLE TO ACHIEVE OR MAINTAIN AN ERECTION (Erectile dysfunction.  Erectile dysfunction)  FEMINIZATION (Feminization, Feminisation acquired)  This spontaneous; report received from a patient via a company  representative concerned a male of unspecified age.  patient height, and medical history were not reported.  The patient received JNJ78436735 (Ad26.COV2.S) (suspension for  injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, start therapy date was not  reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant  medications were reported.  On an unspecified date in MAR-2021. the patient was unable to achieve or maintain an erection as well as  feminization (making him 5'3" and giving him small hands) .  The action with JNJ78436735 (Ad26. cov2.g) was not applicable.  The outcome of the unable to achieve or maintain an erection and feminization was not reported.  This report was serious (Other Medically Important Condition) .  Version created amend previously reported information on 11-MAR-2021- Upon review, the following information  was amended: outcome was updated from possible to not reported in narrative. Null flavor unknown selected for  batch no.
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Product label issue
Clinical narrative: This spontaneous report received from a health care professional concerned multiple patients (five patients) of unspecified age and sex.  The patient's height and weight were not reported. The patient's medical history or concurrent conditions were not reported.  The reporter stated that, none of the 5 patients had a history of cardiovascular issues. The patient's received JANSSEN COVID-19 VACCINE Ad26.COV2.S (suspension for injection, unspecified route, batch number:  1805022 expiry:  25-MAY-2021),  dose was not reported,  administered on 11-MAR-2021 for COVID-19 vaccination.  No concomitant medications were reported. On 08-MAR-2021, it was noted that, the package insert was blank. On 11-MAR-2021, five patients experienced hypotension, and were hospitalized.  A public health manager reported that, she had 5 cases of hypotension after administering Janssen COVID 19 vaccine.  The action taken with COVID-19 vaccineAd26.COV2.S was not reported.  The patients were recovering from hypotension and the outcome of package insert was blank was not reported. The report was associated with product quality complaint number 90000172674. This report was serious  (Hospitalization Caused / Prolonged) .
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram normal, Heart rate increased, Pyrexia
Clinical narrative: HEART RATE INCREASED (Heart rate increased, Heart rate increased) FEVER (Fever, pyrexia) This spontaneous report received from a patient concerned a 26 year old female. The Patient's weight was 59.8 kilograms, and height was 154.94 centimeters. The patient's past medical history included COVID-19 virus test positive on JUN-2020. The patient's concurrent conditions included anxiety (she was unsure if her elevated Heart rate was due to Vaccine or Anxiety). The patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) does not reported, administered on 05-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-20212, the patient experienced fever. On 05-MAR-2021, the patient experienced heart rate increased. The patient was concerned after heart rate was 120 to 135 beats per minute and went to the hospital for evaluation. In hospital she had received blood work evaluations and an EKG. The Patient's reports all test were normal. On MAR-2021, Laboratory data included: Blood test within normal limits, Body temperature : 99.8-100.0 F, Electrocardiogram within normal limits, Heart rate 115 beats per minute (units unspecified) , 120-135 beats per minute. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart rate increased was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and fever and heart rate increased was possible. The company cauality between covid-19 vaccine ad26.cov2.s and fever and heart rate increased was possible. This report was serious (Hospitalization Caused / Prolonged). Add7itional information was received from patient on 10-MAR-2021. The following in2formatio was updated and incorporated in to the case narrative: Patient demographic details (DOB, age group, height, weight and Age at the time of vaccination), Concurrent condition added (Anxiety), Past medical history added (Covid-19 infection), No. Of Days Hospitalized added (No information), Other AE characteristics added, Hospital address added, Lab data added (Body temperature, Heart rate, Blood test, EKG, COVID-19 PCR test), seriousness criteria added for events fever and heart rate increased (Hospitalization Caused / Prolonged and other identification numbers was added. Upon review following information was amended: Route of the of the suspect product changed from unknown to intramuscular, therapy end date changed from 05/Mar/2021 to 05/Mar/2021;12:00, unit dose added (0.5 ml), Dosage text added (vaccinated at 12:00 in an unknown site), Batch number added (unknown), Form of admin and route of admin of treatment drug added (unknown), Lab test date of HEART RATE 115 beats per minute changed from unknown to /MAR/2021. On 24-MAR-2021 received Non significant follow up with email delivery failure notification.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain- Barre syndrome
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tryptase
Clinical narrative: 30mins past vaccination-patient c/o itchy throat able to swallow, but cleaning throat felt getting worse-same sxs with previous  anaphylaxislofish (dietary)
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solutuon diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under the direction of the DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the DOH, as they later questioned their original desecion. The were 30 to 36 doses drawn this solution and this person is 1 of 72 others who may have had a dose of this mix
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 03/27/21 this patient came to COVID Vaccine clinic at that time the person may have received a dose of Pfizer vaccine dlluted with Sterile Water rather than the saline solution dlluent from the manufacturer. Our office was shipped 26 vials of the vaccine 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under direction the DOH sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the DOH, as they later questioned their original desecion.   The were 30 to 36 doses drawn with this solution and this person is 1 to 72 others who may have had a dose of this mix
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the\saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State reported there was a diluent shortage at the time. Under the direction of the stage the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state, as they later questioned their original desecion.  The were 30 to 36 doses drawn with this person is 1 of 72 others who may have had a dose of this mix
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that  time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the  saline solutuon diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or  diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of  the stage DOH the sterile water solution was used. Later we were contacted to report this to both the  patients and VAERS by the state DOH, as they later questioned their original desecion.   The were 30 to 36 doses with this solution and this person is 1 of 72 others who may have had a  dose of this mix
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solutuon diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under the direction of the DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by DOH, as they later questioned their original desecion.   The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion. The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is under the age of current authorization
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: 3 min after being vaccinated with Moderna #2, pt felt nausea, dizzy & clamy. No LOC. Dry heaves. Alert & oriented x 3. Bp 110/80 P=64 & regular
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Feeling cold, Feeling hot, Flushing, Nausea
Clinical narrative: 2 min after receiving 1st dose of Moderna, pt c/o "funny taste" in her mouth and tingling all over - No LOC.  c/o nausea. No vomiting c/o clammy, warm feeling, warm face, face appeared flushed, progressing chilly, clammy, pale 10:55am BP- 138/82 pulse 68 reg, 11:08am 118/78 pulse 60 reg
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Pallor, Paraesthesia, Taste disorder
Clinical narrative: 2 min after receiving 1st dose of Moderna, pt c/o "funny taste" in her mouth and tingling all over - No LOC.  c/o nausea. No vomiting c/o clammy, warm feeling, warm face, face appeared flushed, progressing chilly, clammy, pale 10:55am BP- 138/82 pulse 68 reg, 11:08am 118/78 pulse 60 reg
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction
Clinical narrative: Immediately after being vaccinated (within 1 minute) he felt dizzy, hot, and light headed. He was lowered to the floor and given smelling salts. Ems evaluated, monitored for appoximately 30mins and then was felling better. Patient went home.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Vasovagal Near Syncopal Episode. Good response to Ammonia inhalant and OJ. HR intially 56-76BPM oimety 100%RA.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Paraesthesia oral, Refusal of treatment by patient
Clinical narrative: Patient received 1st Moderna vaccine. 5-10 min after receiving vaccine tongue & lips felt tingling & face felt hot - and appeared flush. 0 SOB, 0 angio edema. 0 genealyed body rash. Evaluated by EMS on scene. Given liquid. Observed. After approximately 30 min symptoms decreased. Patient refused ER eval.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fall, Fatigue, Loss of consciousness
Clinical narrative: About 10 minutes post vaccination, she felt tired, lightheaded, chest pain, and tingling in hand and throat. She states she then passed out and fell out of chair onto the floor. Her mother administered Epi pen. Ems evaluated. Pt transported to hospital ER via ambulance.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal paraesthesia
Clinical narrative: About 10 minutes post vaccination, she felt tired, lightheaded, chest pain, and tingling in hand and throat. She states she then passed out and fell out of chair onto the floor. Her mother administered Epi pen. Ems evaluated. Pt transported to hospital ER via ambulance.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Malaise, Pallor, Presyncope
Clinical narrative: Approximately 1 min after receiving vaccine, patient became diaphoretic, pale & stated he did not feel well. He lost consciousness & was lowered to the floor. No SOB, angioedema or generalized rash. EMS evaluated & transported patient to ER. Discharged from ER with diagnosis of vaso-vagal episode.
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion.   The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion.   The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion.   The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion.  The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis to R Thigh Large Cellulitis to L Thigh Started on Bactrim & Orapred
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Dizziness, Musculoskeletal stiffness, Tenderness
Clinical narrative: Patient had vaccine about 10 minutes prior and was seated in vaccine observation area. At 11:25 am pt then seen laying on floor face down. Turned patient over to back and elevated legs. Pt initially not alert for 2 to 3 seconds than became alert afterwards. Pt body was initially stiff for 2 to 3 seconds then normal tone after. Pt complained feeling dizzy. Initial VS at 11:25am was 140/100, P71 O2 sat 99%. Pt C/o of right side of head tender to touch and rt knee tenderness. Ambulance called and PT taken to ER for assessment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives in the evening after her second covid vaccine. She applied hydrocortisone cream to  the hives.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: She appeared to have seizure 5 to 10 minutes after getting vaccinated.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage
Clinical narrative: 1st Pfizer vaccination on 3-29-21. 3-31-21 patient developed fatigue since 3/31/21. 4-4-21 lymph nodes in L axillary and mod size. approx 1 inch, seen in (withheld).
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: 1st Pfizer vaccination on 3-29-21. 3-31-21 patient developed fatigue since 3/31/21. 4-4-21 lymph nodes in L axillary and mod size. approx 1 inch, seen in (withheld).