chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: EYE IRRITATION/SENSATION OF PRESSURE IN HER EYES; This spontaneous report received from a consumer concerned a female of unspecified age. 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 not reported, batch number: unknown) dose, start therapy date were not reported 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 eye irritation/sensation of pressure in her eyes and had to go to the hospital for surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eye irritation/sensation of pressure in her eyes  was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210420255.; Sender's Comments: V0: 20210420006-Covid-19 vaccine ad26.cov2.s-eye irritation/sensation of pressure in her eyes. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Dermatitis
Clinical narrative: Severe skin reaction:vacuolar interface dermatitis
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient described numbness and tingling in her left arm that lasted a few hours after the vaccination.  It resolved after a couple of hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm pain, all over music pain, dizziness, fatigue, fever, headache. Tylenol was sufficient in treating the symptoms, symptoms lasted about 1.5 days
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm pain, all over music pain, dizziness, fatigue, fever, headache. Tylenol was sufficient in treating the symptoms, symptoms lasted about 1.5 days
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: VOMITING; NAUSEA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 around 12:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 08-APR-2021, treatment medications included: paracetamol. On 08-APR-2021 17:00, the subject experienced chills. On 08-APR-2021 17:00, the subject experienced headache. On 08-APR-2021 17:00, the subject experienced fever. On 08-APR-2021 22:00, the subject experienced nausea. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 09-APR-2021 03:00, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, was recovering from fever, and had not recovered from headache, nausea, and vomiting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; NAUSEA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 around 12:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 08-APR-2021, treatment medications included: paracetamol. On 08-APR-2021 17:00, the subject experienced chills. On 08-APR-2021 17:00, the subject experienced headache. On 08-APR-2021 17:00, the subject experienced fever. On 08-APR-2021 22:00, the subject experienced nausea. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 09-APR-2021 03:00, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, was recovering from fever, and had not recovered from headache, nausea, and vomiting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Hallucination, Tremor, Vomiting
Clinical narrative: 1) After midnight, I began to get what felt like the shivers, but they were unlike anything I had ever seen or experienced, as I could not stop shaking, feeling like I had to try to get warm.  I had a heat pack under my back, and no temperature, but for 25 minutes, kept shaking. 2) At 10am in the morning, I began hallucinating, which has never happened to me before, and I only recognize because when my Dad was dying of prostate cancer, they had him on morphine and he began to see things.  It was a very specific hallucination, of being in a specific from in front of a specific computer talking to a person.  I feel quite reluctant to share this.  This lasted for somewhere between 30 and 45 minutes. 3) I've vomited once, and had diarrhea, drinking lots of water, and only using Tylenol.  I did not take the Tylenol until after I stopped shivering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Seizure
Clinical narrative: Pt presented on 4/20 for 2nd dose of Moderna, in which at that time she informed MD & RN she had a convulsion 1 week after first dose. Pt has hx of convulsions. 2nd dose postponed until evaluation by neurology.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: 8 days after vaccination, patient developed large red rash on the arm where the vaccine was administered
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Pyrexia
Clinical narrative: Fever (101), joint pain, headache, injection site pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Loud ringing in both ears nonstop since first covid vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: PSYCHOTIC EPISODES; MINIMAL SLEEP FOR AT LEAST 50 HOURS; TIREDNESS; This spontaneous report received from a consumer concerned a 29-year-old white  female. The patient's height, and weight were not reported. The patient's concurrent conditions included cognitive disability, but she was not on medication for anything.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10805031 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 in left arm around 4:40 pm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the patient exhibited bizarre behaviors that raised eyebrows but not red flags, as her father thought she was goofing around, she was talking loudly and laughing to herself with nobody around. She seemed very tired, taking a long time in the bathroom (about an hour/an hour and a half). On 03-APR-2021, she was saying things that did not make sense and people could not make sense of what she was talking about. On 04-APR-2021, she started experiencing really bizarre behavior. She was hearing voices, talking to herself and seeing people that were not there, insisting that people were coming over to the house and she had to go there. By the evening, she experienced hallucinations and delusions. She was taken to emergency hospital. She had been awake for about 12 hours, possibly longer. She was tested for a urinary tract infection, but the result was negative. In the emergency room, she had a blood test and computed tomography (CT) scan that did not show anything. In the night on same day, her condition was bad. She was trying to get out of the house. On 05-APR-2021, at 6am, she went back to the hospital room and was admitted to the psych ward for psychotic behaviors. She had been there for 7 days. She had been on unspecified medications, which was helping the symptoms. She was examined by a doctor and admitted to the psychiatric ward. In the evening on same day, her behavior became more severe, showed signs of aggression, flipping furniture, throwing things, saying a light on the wall was watching her. On 06-APR-2021, the psychiatrist stated that she was experiencing psychotic episodes and she was put on antipsychotic medication and examined her. She did not sleep for almost 3 days, started 04-APR-2021 morning at 7:00 am until 06-APR-2021 night (about 50 hours with minimal sleep). Then she was sedated, and she finally slept.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minimal sleep for at least 50 hours on 06-APR-2021, was recovering from psychotic episodes, and the outcome of tiredness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210420207- Covid-19 vaccine ad26.cov2.s-psychotic episodes. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Dizziness, Nausea
Clinical narrative: Slight dizziness within 10 minutes after injection.  Dizziness continues daily for brief periods with slight nausea.   Low body temp - 95.8F average
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: 1 hour after receiving the vaccine, I had a hard spot on the injection site. The area was swollen and red and hot, also itchy. This disappeared after 2 days. I experienced vertigo and fatigue for 3 days. This morning, 1 week after vaccination, my arm became itchy. It is now very swollen at vaccine site. It?s also very itchy and hot. The swollen, hard area is about a 3 inch circle. I also have pain in my arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vertigo
Clinical narrative: 1 hour after receiving the vaccine, I had a hard spot on the injection site. The area was swollen and red and hot, also itchy. This disappeared after 2 days. I experienced vertigo and fatigue for 3 days. This morning, 1 week after vaccination, my arm became itchy. It is now very swollen at vaccine site. It?s also very itchy and hot. The swollen, hard area is about a 3 inch circle. I also have pain in my arm.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Computerised tomogram abdomen, Pain, Pain in extremity
Clinical narrative: Beginning at approximately 9pm on 04/03/21, spasm like pain under back right ribs, radiating around under ribs and up into right shoulder and right arm.  Diagnosis in 4/7 was acute pulmonary embolism in right lung.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary imaging procedure, Ultrasound scan
Clinical narrative: Beginning at approximately 9pm on 04/03/21, spasm like pain under back right ribs, radiating around under ribs and up into right shoulder and right arm.  Diagnosis in 4/7 was acute pulmonary embolism in right lung.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Skin warm, Syncope
Clinical narrative: Patient received Moderna Covid-19 vaccine and fainted approximately 5 minutes later.  Patient reported feeling dizzy, hot and nauseous. Patient's blood pressure 81/41mmHg, heart rate 58 bpm, oxygen level 96% (taken by paramedics) approximately 10 minutes post-vaccination. Paramedics took patient to emergency department to be monitored. Patient was given IV fluids and discharged from the hospital a few hours later. Patient reported that he has a needle phobia and had fainting incident post-vaccination years ago.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Incorrect diluent volume was mixed (the vial contents were diluted with a diluent volume of  0.8 mL instead of 1.8 mL), but a 0.3 mL dose was still administered. We have already talked to Pfizer-BioNtech. They told us that if the dose given in error is the first dose, a second should dose should be administered at the recommended interval of 21 days. If the dose given in error is the second dose, the series is complete, an no additional doses are needed. We have already informed the patients of the potential for local and systemic adverse events.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Swelling face
Clinical narrative: Significant facial swelling on left side. Arm pain on left side. Numbness in neck/jaw area on left side. No other signs of allergic reaction  Received shot on left side.  Transported by companion in personal vehicle.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial, Ultrasound Doppler abnormal
Clinical narrative: Thrombosis of left greater saphenous vein at the knee and proximal leg.  Thrombosed superficial veins in the calf.  Thrombosed peroneal vein of calf on 2/1/21
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dysstasia, Fatigue
Clinical narrative: Very mild fatigue all day and at 5pm until now at 9pm experiencing abdominal pain?hard to stand straight.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness at the injection site the same day,  followed by a rash and hot to the touch on 4/22/21.  Also reports fatigue.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Swallow and itchiness, redness, with some heat at injection site.  It occurs 7 days after the shot, not immediately.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Palpitations, Tachycardia
Clinical narrative: Severe headache that lasted 12 days.  Tachycardia that lasted 8 days. Resting heart rate would jump  from 70 to 115 while sitting and would feel pounding heart and that I couldn?t catch my breath.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Asthenia, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine normal, Contusion, Differential white blood cell count normal, Fatigue, Fibrin D dimer normal
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematochezia, Haematocrit normal, Haemoglobin normal, Headache, Immune thrombocytopenia
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Petechiae, Platelet count decreased, Red blood cell count normal, Thrombocytopenic purpura
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Coagulation time, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Immunoglobulin therapy, Influenza virus test, Platelet count decreased, SARS-CoV-2 test
Clinical narrative: Patient seen at medical facility 4/6/2021 with headache, fatigue, lower extremity petechial rash, unexplained bruising, small amount of blood in stool. CBC ordered 4/6/2021 and obtained on 4/8/2021. Platelet count was 4 x 10^9/L. Patient admitted to hospital. Hematology/Oncology consult obtained. Patient diagnosed with Immune Thrombocytopenia Purpura (ITP). 4/9/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone.  Platelets increased to 15 x 10^9/L.  4/10/2021 Given 1g/kg IVIG and 125mg IV methylprednisolone, platelets increased to 81 x 10^9/L.  Patient discharged on oral prednisone with Hematology/Oncology outpatient follow-up.  Patient advised to stop Goodies Powder for Headache.  4/13/2021 patient returned to hospital emergency department with generalized weakness. His platelets were rechecked and were 277 x 10^9/L. D-Dimer was undetectable at <0.27.  Patient was discharged home from the emergency department.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: - Pain at injection site starting around 2 hours after injection - Fever: temperature taken approx. 12 hours after injection, 100.7 F - Chills accompanied by fever
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Injection site pruritus, Injection site rash
Clinical narrative: My arm started swelling that night, 04/21. It was painful to move or brush against anything. The next morning 04/22, I couldn?t move my arm without extreme pain, it hurt to even change into my work clothes(I work from home), I had a fever, shaking chills, fatigue, and a head ache that didn?t stop until about 8p. I logged off from work about 645p. I went to shower and noted a new quarter sized rash that was at the injection site with a white dot near the center. Today 04/23, no fever or chills but headache and fatigue persisted. Tonight 04/23, rash is now the size of a baseball, there is a marble size lump underneath my skin and the rash is pink and even in color, the white dot at injection site is still there, it?s been itchy today but I haven?t touched it.  I am healthy, have zero existing medical conditions and confused on my body?s reaction to my initial vaccination.  I am 5?3? and 118 lb. I take nothing but birth control. I get sick maybe once every couple years, nothing major, just based on cold/flu season. I get my flu shot annually. My lymph nodes are normal, no swelling anywhere else, no other side effects.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Peripheral swelling, Pyrexia, Tremor
Clinical narrative: My arm started swelling that night, 04/21. It was painful to move or brush against anything. The next morning 04/22, I couldn?t move my arm without extreme pain, it hurt to even change into my work clothes(I work from home), I had a fever, shaking chills, fatigue, and a head ache that didn?t stop until about 8p. I logged off from work about 645p. I went to shower and noted a new quarter sized rash that was at the injection site with a white dot near the center. Today 04/23, no fever or chills but headache and fatigue persisted. Tonight 04/23, rash is now the size of a baseball, there is a marble size lump underneath my skin and the rash is pink and even in color, the white dot at injection site is still there, it?s been itchy today but I haven?t touched it.  I am healthy, have zero existing medical conditions and confused on my body?s reaction to my initial vaccination.  I am 5?3? and 118 lb. I take nothing but birth control. I get sick maybe once every couple years, nothing major, just based on cold/flu season. I get my flu shot annually. My lymph nodes are normal, no swelling anywhere else, no other side effects.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hiccups, Pain, Pyrexia
Clinical narrative: Second dose on 4/18 with high fever, chills, body aches that evening. Fever broke early AM on 4/19 then on 4/20 around 8 PM hiccups started and have remained persistent and still occur at the time of this writing.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt started feeling lightheaded/dizzy after vaccine (second dose), and was escorted to treatment area where history and vitals were obained. Pt stated this is a common reaction for him following any injection. He was given water and monitored. Initial VS: P=72, BP=112/66  P. Ox=97%   After several minutes and pt stating he was feeling fine, he sat up. VS: P=88  BP=126/64  P. Ox=98%   After a few more minutes, he stood up, felt fine. VS: P=94  BP=122/80  P. Ox=98%   Pt discharged home without further incident. Advised to get next shot laying on cot.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Muscular weakness, Pain in extremity, Sensitive skin
Clinical narrative: Day after vaccine, left arm felt very weak and sore, and could not raise arm from the shoulder. Symptoms resolved by the third day. One week from the vaccine, slight soreness returned at injection site. On the 8th day, slight soreness/sensitivity continues and a pink, slightly raised area has appeared (approx 3? x 3? irregular patch or rash) at the injection area. No itching  at this point.
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Blood alkaline phosphatase, Lymphocyte count, Monocyte count, Myalgia, White blood cell count
Clinical narrative: Pain in biceps muscles, thigh muscles and buttock muscles. There was NO JOINT pain Systemic Inflammation
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary gland mass
Clinical narrative: Subcentimeter 7 mm nodular density at the left premandibular soft tissues, favoring to represent a reactive lymph node,
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Moderna COVID?19 Vaccine EUA  Rash appeared on the arm around the injection local
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Electrocardiogram, Hyperhidrosis, Loss of consciousness, Tremor
Clinical narrative: Patient came for his second dose of COVID-19 vaccine. Before giving the vaccine, I asked the patient if they had any problems with the first dose and they stated that they did not. After giving the vaccine I went back inside the pharmacy to throw away the supplies and his son-in-law called me over to take a look at the patient. The patient had his eyes closed and head tilted back and started shaking for a couple of seconds. I had my technician call 911 at this moment. The patient has lost consciousness and I took the patients mask off to assess and confirm that he was breathing which he was. Upon regaining consciousness the patient was disoriented and sweating. Unfortunately it was difficult to find out how the patient was feeling due to a language barrier. I monitored the patient until the paramedics arrived which they took out the EKG and injected him with an IV. His BP was 107/62, HR in the 70s, and not sure if I overheard correctly but bloodsugar of 163. The EKG report stated that the patient was having a STEMI but when they printed it out there was no ST elevation. The paramedics took care of the situation and took him in for further evaluation.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Lip swelling, Malaise, Nausea, Paraesthesia oral
Clinical narrative: Pt received covid-19 vaccine, 2nd one ~ 3:10 pm. Approx 10 minutes later experienced some chest tightness (but not shortness of breath or wheezing) and feeling some lip swelling and tingling as well as facial itching. She also felt somewhat ill in general. She laid down. After 20 more minutes she got up and felt worse with more facial itching and also now nauseous. She was sent to ED. From ED record - The patient received 4 mg IV zofran, 50 mg of Benadryl IV, 20 mg of Pepcid IV, 125 mg of Solu-Medrol IV and a 1 L normal saline bolus for hydration and possible allergic reaction. She felt better with improvement in symptoms and was discharged home in good condition. A course of prednisone and an epi pen was prescribed to her.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt received covid-19 vaccine, 2nd one ~ 3:10 pm. Approx 10 minutes later experienced some chest tightness (but not shortness of breath or wheezing) and feeling some lip swelling and tingling as well as facial itching. She also felt somewhat ill in general. She laid down. After 20 more minutes she got up and felt worse with more facial itching and also now nauseous. She was sent to ED. From ED record - The patient received 4 mg IV zofran, 50 mg of Benadryl IV, 20 mg of Pepcid IV, 125 mg of Solu-Medrol IV and a 1 L normal saline bolus for hydration and possible allergic reaction. She felt better with improvement in symptoms and was discharged home in good condition. A course of prednisone and an epi pen was prescribed to her.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Blood test, Computerised tomogram
Clinical narrative: Acute appendicitis
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Severe ringing in the ears; some mild difficulty hearing
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Hypoaesthesia, Throat irritation
Clinical narrative: Burning eyes, Burning Throat, Liquid going down throat.  Numbness on left side of face. 30 minutes after shot. Burning eyes and throat lasted 10 minutes. Numbness in face lasted around 12 hours.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Flushing, Hot flush, Tinnitus
Clinical narrative: After 6 days, I started having occasional vertigo, intermittent tinnitus, general increased dizziness, and afternoon flushed (red hot) face. Vertigo lasted 3 days, other symptoms still present one week later. I have a long history of immune problems and am disabled by chronic fatigue, with some dizziness present daily before receiving the vaccine. I think the vaccine triggered my already overactive immune system into increased inflammation, which affected my inner ear nerve causing the vertigo. Extremely unpleasant but thankful I did not fall or vomit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: After 6 days, I started having occasional vertigo, intermittent tinnitus, general increased dizziness, and afternoon flushed (red hot) face. Vertigo lasted 3 days, other symptoms still present one week later. I have a long history of immune problems and am disabled by chronic fatigue, with some dizziness present daily before receiving the vaccine. I think the vaccine triggered my already overactive immune system into increased inflammation, which affected my inner ear nerve causing the vertigo. Extremely unpleasant but thankful I did not fall or vomit.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness that turned into light headedness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash started almost 2 days after 2nd Moderna vaccine.  Started off as small rash on stomach in the morning and spread to whole stomatch, chest, and back by afternoon.  Does not itch.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia, Vomiting
Clinical narrative: CHILLS; INJECTION SITE SORENESS; VOMITING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced fever. On 11-APR-2021 02:15, the subject experienced vomiting. On an unspecified date, the subject experienced chills, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, vomiting, chills and injection site soreness was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: DIZZY/LIGHTHEADED; RUBBER LEGS; HEART RACING; LOOKED WHITE; NEAR SYNCOPAL EPISODE/NEARLY PASSED OUT; INTERMITTENTLY FEELING HOT; FLUSH; FOGGY; NOT FEELING WELL; BLURRY VISION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced blurry vision. On 01-APR-2021, the subject experienced intermittently feeling hot. On 01-APR-2021, the subject experienced flush. On 01-APR-2021, the subject experienced foggy. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced near syncopal episode/nearly passed out. On 02-APR-2021, the subject experienced heart racing. On 02-APR-2021, the subject experienced looked white. On 03-APR-2021, the subject experienced dizzy/lightheaded. On 03-APR-2021, the subject experienced rubber legs. On 05-APR-2021, Laboratory data included: ECG (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from near syncopal episode/nearly passed out on 02-APR-2021, heart racing on 04-APR-2021, and blurry vision on 30-MAR-2021, was recovering from intermittently feeling hot, flush, foggy, not feeling well, dizzy/lightheaded, and rubber legs, and the outcome of looked white was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness, Pallor, Palpitations, Presyncope
Clinical narrative: DIZZY/LIGHTHEADED; RUBBER LEGS; HEART RACING; LOOKED WHITE; NEAR SYNCOPAL EPISODE/NEARLY PASSED OUT; INTERMITTENTLY FEELING HOT; FLUSH; FOGGY; NOT FEELING WELL; BLURRY VISION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced blurry vision. On 01-APR-2021, the subject experienced intermittently feeling hot. On 01-APR-2021, the subject experienced flush. On 01-APR-2021, the subject experienced foggy. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced near syncopal episode/nearly passed out. On 02-APR-2021, the subject experienced heart racing. On 02-APR-2021, the subject experienced looked white. On 03-APR-2021, the subject experienced dizzy/lightheaded. On 03-APR-2021, the subject experienced rubber legs. On 05-APR-2021, Laboratory data included: ECG (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from near syncopal episode/nearly passed out on 02-APR-2021, heart racing on 04-APR-2021, and blurry vision on 30-MAR-2021, was recovering from intermittently feeling hot, flush, foggy, not feeling well, dizzy/lightheaded, and rubber legs, and the outcome of looked white was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: DIZZY/LIGHTHEADED; RUBBER LEGS; HEART RACING; LOOKED WHITE; NEAR SYNCOPAL EPISODE/NEARLY PASSED OUT; INTERMITTENTLY FEELING HOT; FLUSH; FOGGY; NOT FEELING WELL; BLURRY VISION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced blurry vision. On 01-APR-2021, the subject experienced intermittently feeling hot. On 01-APR-2021, the subject experienced flush. On 01-APR-2021, the subject experienced foggy. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced near syncopal episode/nearly passed out. On 02-APR-2021, the subject experienced heart racing. On 02-APR-2021, the subject experienced looked white. On 03-APR-2021, the subject experienced dizzy/lightheaded. On 03-APR-2021, the subject experienced rubber legs. On 05-APR-2021, Laboratory data included: ECG (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from near syncopal episode/nearly passed out on 02-APR-2021, heart racing on 04-APR-2021, and blurry vision on 30-MAR-2021, was recovering from intermittently feeling hot, flush, foggy, not feeling well, dizzy/lightheaded, and rubber legs, and the outcome of looked white was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE ACHES; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: CA3A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle aches. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) below 100F. On 07-APR-2021 20:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle aches, headache, and low grade fever on 09-APR-2021. This report was non-serious. This case is a duplicate of 20210421639.  Additional information was received from patient on 09-APR-2021. It was determined that Manufacture case number 20210421639 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacture case number 20210420734.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Headache, Hypersensitivity, Myalgia
Clinical narrative: HIGH HEART BEAT / TACHYCARDIA; ALLERGIC REACTION (SWOLLEN FACE UNDER EYES, ITCHINESS IN MOUTH, ITCHINESS IN PALMS / FEET); SHAKINESS; TINGLING; FEVER; HEADACHE; WEAKNESS; MUSCLE PAIN IN BACK AND LEGS; DROWSINESS / SLEEPINESS; BACK PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced drowsiness / sleepiness. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced muscle pain in back and legs. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced high heart beat / tachycardia. On 02-APR-2021, the subject experienced allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet). On 02-APR-2021, the subject experienced shakiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart beat / tachycardia, and muscle pain in back and legs on 02-APR-2021, drowsiness / sleepiness, and weakness on 16-MAR-2021, tingling on 28-MAR-2021, fever on 18-MAR-2021, and headache on 19-MAR-2021, had not recovered from shakiness, and allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet), and the outcome of back pain and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Somnolence, Tachycardia
Clinical narrative: HIGH HEART BEAT / TACHYCARDIA; ALLERGIC REACTION (SWOLLEN FACE UNDER EYES, ITCHINESS IN MOUTH, ITCHINESS IN PALMS / FEET); SHAKINESS; TINGLING; FEVER; HEADACHE; WEAKNESS; MUSCLE PAIN IN BACK AND LEGS; DROWSINESS / SLEEPINESS; BACK PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced drowsiness / sleepiness. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced muscle pain in back and legs. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced high heart beat / tachycardia. On 02-APR-2021, the subject experienced allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet). On 02-APR-2021, the subject experienced shakiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart beat / tachycardia, and muscle pain in back and legs on 02-APR-2021, drowsiness / sleepiness, and weakness on 16-MAR-2021, tingling on 28-MAR-2021, fever on 18-MAR-2021, and headache on 19-MAR-2021, had not recovered from shakiness, and allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet), and the outcome of back pain and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: HIGH HEART BEAT / TACHYCARDIA; ALLERGIC REACTION (SWOLLEN FACE UNDER EYES, ITCHINESS IN MOUTH, ITCHINESS IN PALMS / FEET); SHAKINESS; TINGLING; FEVER; HEADACHE; WEAKNESS; MUSCLE PAIN IN BACK AND LEGS; DROWSINESS / SLEEPINESS; BACK PAIN; BODY ACHES; This spontaneous report received from a patient concerned a 30 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced back pain. On MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced drowsiness / sleepiness. On 14-MAR-2021, the subject experienced weakness. On 14-MAR-2021, the subject experienced muscle pain in back and legs. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced high heart beat / tachycardia. On 02-APR-2021, the subject experienced allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet). On 02-APR-2021, the subject experienced shakiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high heart beat / tachycardia, and muscle pain in back and legs on 02-APR-2021, drowsiness / sleepiness, and weakness on 16-MAR-2021, tingling on 28-MAR-2021, fever on 18-MAR-2021, and headache on 19-MAR-2021, had not recovered from shakiness, and allergic reaction (swollen face under eyes, itchiness in mouth, itchiness in palms / feet), and the outcome of back pain and body aches was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Lymphadenopathy, Swelling face
Clinical narrative: HEAT BLISTERS; SWOLLEN GLANDS; LEFT SIDE OF FACE ENLARGED/SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included neck tumor, and concurrent conditions included non-hodgkins lymphoma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: hydrocortisone. On 08-APR-2021, the subject experienced swollen glands. On 08-APR-2021, the subject experienced left side of face enlarged/swollen. On 10-APR-2021, the subject experienced heat blisters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen glands, and left side of face enlarged/swollen, and had not recovered from heat blisters. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.