chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Somnolence
Clinical narrative: Patient. Received her second dose of Pfizer (LOT#: EC3183) at 1835 on 8/17/21. Patient alerted EMT and reported feeling lightheaded, dizzy, was experiencing shortness of breathe and chest pressure. EMT took patients vital signs. BP: 158/78, HR: 49, O2: 100%. Patient stated that the same thing happened with her first dose 40 minutes after completing her observation time. Symptoms resolved with food and rest. Patient also stated that heart rate is low and is normal for her. At 1850 patient stated that she "feels chills" and the chest pressure and dizziness had improved and that she feels sleepy. EMT retook patients vitals signs at 1850. BP: 130/91, HR: 48, O2: 100%. At 1900 patient stated that she had not had any water today and no longer was experiencing any chills or any other symptoms. EMT retook patients vital signs at 1900. BP: 114/72, HR: 43, 02: 100%. EMT retook and reassessed patient at 1911. BP: 104/72, HR: 44, O2: 98%. Patient stated that she was no longer feeling any symptoms. EMT moved patient to zero gravity chair at 1920. Patient completed her observation time. EMT educated patient on adverse effects of COVID vaccine and when to seek EMS. Patient verbalized understanding of education. Patient stood up on her own and walked out of vaccination site with a steady gait at 1924.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Continuous positive airway pressure, Cough, Decreased appetite, Dyspnoea
Clinical narrative: June 20 at 4 weeks after the vaccination, I began feeling very tired and lathargic.  june 26 i took my temperature at it was 101. for the next ten days I was in bed , eating very little, and foggy thinking. the worst part was the 103.5 temperature when I was not able to speak in a complete sentence without coughing .  I had trouble breathing and after a virtual appointment with my doctor was perscribed zpak and albuterol and cepcol. I was unable to sleep with my CPAP machine because I was coughing during the night in bed.  It was almost 3 weeks later when I was back to my normal self of eating ,   for the next 3 month (to day) I require exceessive sleep - 10 to 13 hours a night with 2 hour naps a couple times a week.  I have seem a sleep doctor and am pleased to report my CPAP machine settings are new and now functioning well so that I can sleep uninterrupted with the RESMED machine therapy.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Lethargy, Mobility decreased
Clinical narrative: June 20 at 4 weeks after the vaccination, I began feeling very tired and lathargic.  june 26 i took my temperature at it was 101. for the next ten days I was in bed , eating very little, and foggy thinking. the worst part was the 103.5 temperature when I was not able to speak in a complete sentence without coughing .  I had trouble breathing and after a virtual appointment with my doctor was perscribed zpak and albuterol and cepcol. I was unable to sleep with my CPAP machine because I was coughing during the night in bed.  It was almost 3 weeks later when I was back to my normal self of eating ,   for the next 3 month (to day) I require exceessive sleep - 10 to 13 hours a night with 2 hour naps a couple times a week.  I have seem a sleep doctor and am pleased to report my CPAP machine settings are new and now functioning well so that I can sleep uninterrupted with the RESMED machine therapy.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence
Clinical narrative: June 20 at 4 weeks after the vaccination, I began feeling very tired and lathargic.  june 26 i took my temperature at it was 101. for the next ten days I was in bed , eating very little, and foggy thinking. the worst part was the 103.5 temperature when I was not able to speak in a complete sentence without coughing .  I had trouble breathing and after a virtual appointment with my doctor was perscribed zpak and albuterol and cepcol. I was unable to sleep with my CPAP machine because I was coughing during the night in bed.  It was almost 3 weeks later when I was back to my normal self of eating ,   for the next 3 month (to day) I require exceessive sleep - 10 to 13 hours a night with 2 hour naps a couple times a week.  I have seem a sleep doctor and am pleased to report my CPAP machine settings are new and now functioning well so that I can sleep uninterrupted with the RESMED machine therapy.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Dizziness, Fatigue
Clinical narrative: Body aches, fever, nausea,  dizziness, weakness, tiredness, extreme flu-like symptoms
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Body aches, fever, nausea,  dizziness, weakness, tiredness, extreme flu-like symptoms
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt recieved Moderna for 1st 2 doses of vaccine. Pfizer was administered and upon examination of pt card, She had recieved Moderna for first 2 doses.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Patient called the pharmacy on 8/20/21 with complaint of fever, flu-like symptoms, pain, and nausea. She was instructed to take Tylenol or ibuprofen but stated she vomited the ibuprofen back up and did not feel well. Patient was recommended to follow up in the ER if her symptoms did not improve. She went to the emergency room and was given an IV and was prescribed an antibiotic, nausea medication, and itching medication. Patient was discharged from the ER in the same day.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient called the pharmacy on 8/20/21 with complaint of fever, flu-like symptoms, pain, and nausea. She was instructed to take Tylenol or ibuprofen but stated she vomited the ibuprofen back up and did not feel well. Patient was recommended to follow up in the ER if her symptoms did not improve. She went to the emergency room and was given an IV and was prescribed an antibiotic, nausea medication, and itching medication. Patient was discharged from the ER in the same day.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 09:08 PATIENT STATES THINKS SHE MAYBE HAVING A LITTLE HARAD TIME BREATHING. PATIENT HAS NO LIP OR TONGUE SWELLING  AND IN NO APPARENT DESTRESS.  09:20 PATIENT TATES FEELS FINE MOM STATES FEELS OK WITH LEAVING AND FOLLOWING UP WITH URGENT CARE IF SYMPTOMS RETURN FURTHER NEEDS. PATIENT LEFT WITH MOM IN NO APPARENT DISTRESS.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Hyperacusis, Pain, Photophobia
Clinical narrative: Fever, horrendous body aches even in fingers and toes, headache, sensitivity to light and sound, no appetite
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, horrendous body aches even in fingers and toes, headache, sensitivity to light and sound, no appetite
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Insomnia
Clinical narrative: Stabbing pains in heart all night / anytime I lay down. Cannot get into hospital as they are full of Covid patients in my area but called my doctor. I have never had stabbing chest pains in my entire life, it kept me awake all night and is still occurring during the day.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Facial pain, Fatigue, Injection site pain
Clinical narrative: Excessive swelling in armpit that extended to shoulder blade. Swelling lasted a few days (5-6), pain at injection site.  Extreme/abnormal fatigue, unusually extreme feeling of malaise, intermittent dizziness affecting normal activity,  Also, higher level of pain in lower back, nerve pain in legs and  feet still ongoing and requiring use of OTC (Tylenol), however the pain is still present, sometimes constant and sometimes intermittent.  Patient feels the vaccine caused increased pain sensations in back, legs and feet.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Lymphadenopathy, Malaise, Neuralgia, Pain in extremity
Clinical narrative: Excessive swelling in armpit that extended to shoulder blade. Swelling lasted a few days (5-6), pain at injection site.  Extreme/abnormal fatigue, unusually extreme feeling of malaise, intermittent dizziness affecting normal activity,  Also, higher level of pain in lower back, nerve pain in legs and  feet still ongoing and requiring use of OTC (Tylenol), however the pain is still present, sometimes constant and sometimes intermittent.  Patient feels the vaccine caused increased pain sensations in back, legs and feet.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Excessive swelling in armpit that extended to shoulder blade. Swelling lasted a few days (5-6), pain at injection site.  Extreme/abnormal fatigue, unusually extreme feeling of malaise, intermittent dizziness affecting normal activity,  Also, higher level of pain in lower back, nerve pain in legs and  feet still ongoing and requiring use of OTC (Tylenol), however the pain is still present, sometimes constant and sometimes intermittent.  Patient feels the vaccine caused increased pain sensations in back, legs and feet.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Started out pain in both hands by the thumb. Pain then went to my left elbow area, then to my right elbow area.  Started getting into my toes and fingers.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose 16 days after the first dose.  Patient stated he had a headache from the shot.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Ischaemic stroke, Magnetic resonance imaging head abnormal, Thalamic infarction
Clinical narrative: Small right thalamic ischemic stroke (proven on MRI) with left-sided total body numbness.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Presyncope, Syncope
Clinical narrative: syncope, vagal response:  within one minute after administration, fainted.  Elevated feet prior to administration as he has history of fainting with shot administration.  Wife splashed water on his face, I placed cold wet compress at base of neck, we managed to contain him in chair with feet elevated.  took about  one minute to regain consciousness, BP readings were 84/54 mmHg HR 50, then 108/60mmHg HR 62 about 2 minutes later.  EMS was called as he was fainting.  They came and assessed him and diagnosed vagal response.  They left him at pharmacy to recover fully.  Last BP reading before leaving pharmacy was 95/65mmHg HR 62, about 10-15 minutes after.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of personal independence in daily activities, Tinnitus, Tremor
Clinical narrative: A few days after the first  shot I went for a bike ride. After the ride I could not stop shaking and my blood felt like it had been poisoned. My ears were ringing also. I had to take a week off from exercise. Today, one week later, I tried to workout which I have done on a regular basis all my life. I had to stop halfway through because my body started shaking very badly and my ears rang. I was so out of sorts I had to lay down. This has never happened to me before.  I think this shot has made me very ill.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pruritus, Skin swelling
Clinical narrative: 8 days after my vaccine, I developed a rather large triangular rash at the injection site. The skin is red, puffy, hot, and itchy.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient stated that he was feeling lightheaded and dizzy. gave him a bottle of water and put some icepacks on his neck to cool him off and stood by him for 5 minutes , after that he felt better
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Oropharyngeal pain
Clinical narrative: Metallic taste in mouth rear part of tongue, loss of taste. Sore tonsils
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Paraesthesia
Clinical narrative: After administering the vaccine, I asked the patient to have a seat in the pharmacy lobby/waiting area for 15 minutes. While seated, the patient lost consciousness for approximately one minute. After regaining consciousness, she said she had a tingling sensation in her arm and started to feel dizzy.  EMS arrived shortly after and checked her vitals then took her via ambulance to Hospital for observation.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pallor
Clinical narrative: After the shot was given, she walked with her mother and sister to sit down for 15 minutes. Before I could get inside the pharmacy my cashier said the little girl is sick. She was sitting in the chair with  her legs stretched, her head was back and her eyes were closed. Her mom and I lifted her on the mat on the floor and her mom and dad kept talking to her to try to arouse her. We placed a cold pack and cool napkins on her forehead and back of her neck. She was pale she opened her eyes but was not talking. She kept closing her eyes and putting her head  back. We kept talking to her and her mom asked her if she knew where she was and she answered pharmacy. The parents did not want to call 911 because this has happened before a long time ago when she cut herself in the shower.  In that previous incident 911 came and  she recovered in about 5 minutes. Today mom and dad said the same thing was happening but this  time was longer than 5 minutes.  She was able to stand on her own with support from  dad and they left with her slowing  walking out.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt felt faint and started to sweat after receiving the vaccine. We laid him down on a flat surface with his feet up for a few minutes. Used wet towels and ice packs to cool him down.  Felt better after a few minutes and was able to sit at ' post vaccination site'. After a few more minutes he stated that he wasn't feeling 'good' and so laid him down again and called 911 who then came ad took care of him. Called  him after 7 pm , spoke with him and he stated that he was feeling fine.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperhidrosis
Clinical narrative: Hyperhidrosis in joints; Joint pain; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Hyperhidrosis in joints) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced HYPERHIDROSIS (Hyperhidrosis in joints) and ARTHRALGIA (Joint pain). At the time of the report, HYPERHIDROSIS (Hyperhidrosis in joints) and ARTHRALGIA (Joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Vomiting
Clinical narrative: FELT MISERABLE; VOMITTING VIOLENTLY; COULDN'T EAT; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FELT MISERABLE), VOMITING (VOMITTING VIOLENTLY) and FEEDING DISORDER (COULDN'T EAT) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (FELT MISERABLE), VOMITING (VOMITTING VIOLENTLY) and FEEDING DISORDER (COULDN'T EAT). At the time of the report, FEELING ABNORMAL (FELT MISERABLE), VOMITING (VOMITTING VIOLENTLY) and FEEDING DISORDER (COULDN'T EAT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications are not reported. The Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness). At the time of the report, VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence, Rash macular, Rash pruritic, Skin discolouration
Clinical narrative: intestinal gas; loose stool/not having normal stool; red dotted rash that went up the inside and back of his legs; itchy rash that went up the inside and back of his legs; skin became discolored; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (intestinal gas), DIARRHOEA (loose stool/not having normal stool), RASH MACULAR (red dotted rash that went up the inside and back of his legs), RASH PRURITIC (itchy rash that went up the inside and back of his legs) and SKIN DISCOLOURATION (skin became discolored) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced FLATULENCE (intestinal gas), DIARRHOEA (loose stool/not having normal stool), RASH MACULAR (red dotted rash that went up the inside and back of his legs), RASH PRURITIC (itchy rash that went up the inside and back of his legs) and SKIN DISCOLOURATION (skin became discolored). In March 2021, FLATULENCE (intestinal gas), RASH MACULAR (red dotted rash that went up the inside and back of his legs), RASH PRURITIC (itchy rash that went up the inside and back of his legs) and SKIN DISCOLOURATION (skin became discolored) had resolved and DIARRHOEA (loose stool/not having normal stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Not feeling very well; Fever; pain on the arm where the vaccine was administered which has markedly increased in intensity over time; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Not feeling very well), PYREXIA (Fever) and VACCINATION SITE PAIN (pain on the arm where the vaccine was administered which has markedly increased in intensity over time) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling very well), PYREXIA (Fever) and VACCINATION SITE PAIN (pain on the arm where the vaccine was administered which has markedly increased in intensity over time). At the time of the report, MALAISE (Not feeling very well), PYREXIA (Fever) and VACCINATION SITE PAIN (pain on the arm where the vaccine was administered which has markedly increased in intensity over time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. The patient reported that he experienced fever during the first two days after administration, also not feeling very well. Gradually, he began experiencing pain on the arm  where the vaccine was administered, which has markedly increased in intensity over time and is still ongoing. He took oxycontin and other unspecified pain medication but was screaming from pain as the pain pills were not helping him.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: coughed all night; broke up his chest congestion; coughed up a lot of phlegm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughed all night), CHEST DISCOMFORT (broke up his chest congestion) and COUGH (coughed up a lot of phlegm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (coughed all night), CHEST DISCOMFORT (broke up his chest congestion) and COUGH (coughed up a lot of phlegm). On 31-Mar-2021, COUGH (coughed all night), CHEST DISCOMFORT (broke up his chest congestion) and COUGH (coughed up a lot of phlegm) had resolved.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site reaction
Clinical narrative: sensitivity in arm at the site of injection; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (sensitivity in arm at the site of injection), CHILLS (chills) and PYREXIA (low grade fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN & MINERAL and COLFORSIN, CURCUMA LONGA (TURMERIC + FORSKOLIN) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever). On an unknown date, the patient experienced VACCINATION SITE REACTION (sensitivity in arm at the site of injection). At the time of the report, VACCINATION SITE REACTION (sensitivity in arm at the site of injection), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Covid arm; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (Covid arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Covid arm). At the time of the report, PAIN IN EXTREMITY (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-066393 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vaccination site pain
Clinical narrative: Pain at injection site; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Fatigue, Pain
Clinical narrative: Sore arm; Difficulty breathing at times; Achy; Having difficulty urinating; Chills; Fever; Fever 101.6; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating), CHILLS (Chills), PYREXIA (Fever), PYREXIA (Fever 101.6) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating), CHILLS (Chills), PYREXIA (Fever), PYREXIA (Fever 101.6) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101.6 (Inconclusive) Fever of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Urinary tract infection
Clinical narrative: Sore arm; Difficulty breathing at times; Achy; Having difficulty urinating; Chills; Fever; Fever 101.6; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COVID-19.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating), CHILLS (Chills), PYREXIA (Fever), PYREXIA (Fever 101.6) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), DYSPNOEA (Difficulty breathing at times), PAIN (Achy), URINARY TRACT INFECTION (Having difficulty urinating), CHILLS (Chills), PYREXIA (Fever), PYREXIA (Fever 101.6) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101.6 (Inconclusive) Fever of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Illness, Influenza like illness, Malaise, Nausea
Clinical narrative: Still dose not feel great this morning; Fellt sick all the day; Exactly like when she gets the flu; Remained in bed all day long; Felt nauseous; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous) and PYREXIA (Slight fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous) and PYREXIA (Slight fever). On 04-Apr-2021, the patient experienced MALAISE (Still dose not feel great this morning). At the time of the report, ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous), PYREXIA (Slight fever) and MALAISE (Still dose not feel great this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not given.   No treatment information was not given.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Still dose not feel great this morning; Fellt sick all the day; Exactly like when she gets the flu; Remained in bed all day long; Felt nauseous; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous) and PYREXIA (Slight fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous) and PYREXIA (Slight fever). On 04-Apr-2021, the patient experienced MALAISE (Still dose not feel great this morning). At the time of the report, ILLNESS (Fellt sick all the day), INFLUENZA LIKE ILLNESS (Exactly like when she gets the flu), BED REST (Remained in bed all day long), NAUSEA (Felt nauseous), PYREXIA (Slight fever) and MALAISE (Still dose not feel great this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not given.   No treatment information was not given.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Malaise, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), DECREASED APPETITE (Less or no appetite), MALAISE (Feels very sick), VOMITING (Vomiting) and CHILLS (Feeling chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure and Diabetes. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS (Light headedness), DECREASED APPETITE (Less or no appetite), MALAISE (Feels very sick), VOMITING (Vomiting) and CHILLS (Feeling chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headedness), DECREASED APPETITE (Less or no appetite), MALAISE (Feels very sick), VOMITING (Vomiting) and CHILLS (Feeling chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products included blood pressure pills and diabetes pill. Patient experienced the events three  hours after vaccine administration; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itching all over body). On 15-Mar-2021, PRURITUS (itching all over body) had resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness like when you're drunk; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness like when you're drunk) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fall (History of falls). Concurrent medical conditions included Dementia (Which varies in severity daily).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness like when you're drunk). At the time of the report, DIZZINESS (Dizziness like when you're drunk) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.  Patient reports the occurring of dizziness when  woke up the morning after receiving the dose.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Vaccination site pain
Clinical narrative: not able to sleep at night; sore left arm at injection site and left arm pain at the injection site had gotten worse; very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (not able to sleep at night), FATIGUE (very tired) and VACCINATION SITE PAIN (sore left arm at injection site and left arm pain at the injection site had gotten worse) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included VALSARTAN, AMLODIPINE, PAROXETINE, MONTELUKAST SODIUM (SINGULAIR), CARVEDILOL, METFORMIN and PRIMIDONE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (very tired). On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm at injection site and left arm pain at the injection site had gotten worse). On an unknown date, the patient experienced INSOMNIA (not able to sleep at night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and MENTHOL (BIOFREEZE PAIN RELIEVING) at an unspecified dose and frequency. At the time of the report, INSOMNIA (not able to sleep at night), FATIGUE (very tired) and VACCINATION SITE PAIN (sore left arm at injection site and left arm pain at the injection site had gotten worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: little itchy; Redness from top of the shoulder to arm; little warm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itchy), ERYTHEMA (Redness from top of the shoulder to arm) and FEELING HOT (little warm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRURITUS (little itchy), ERYTHEMA (Redness from top of the shoulder to arm) and FEELING HOT (little warm). At the time of the report, PRURITUS (little itchy), ERYTHEMA (Redness from top of the shoulder to arm) and FEELING HOT (little warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Cough, Headache, Pain in extremity
Clinical narrative: dry coughs; been in bed all week; sore arm; chills; strange headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry coughs), BEDRIDDEN (been in bed all week), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (strange headaches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B10RTYK) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (dry coughs), BEDRIDDEN (been in bed all week), PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (strange headaches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, COUGH (dry coughs), BEDRIDDEN (been in bed all week), CHILLS (chills) and HEADACHE (strange headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs include Blood pressure medication.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a non-healthcare professional, describes the occurrence of chest pain (pain in chest, headaches, body aches), pyrexia (fever 101.8°F), headache (pain in chest, headaches, body aches), myalgia (pain in chest, headaches, body aches) and fatigue in a 71-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 2, 2021, patient experienced chest pain (pain in chest, headaches, body aches), pyrexia (fever 101.8°F), headache (pain in chest, headaches, body aches), myalgia (pain in chest, headaches, body aches) and fatigue. At the time of the report, chest pain (pain in chest, headaches, body aches), pyrexia (fever 101.8 °F), headache (pain in chest, headaches, body aches), myalgia (pain in chest, headaches, body aches) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No medical history, concomitant medications or treatment medications provided in source document. Reporter did not allow further contact. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Head discomfort, Headache
Clinical narrative: sick; felt like head was gonna explode; couldn't even open bottle of water so weak/stayed in bed all day until 9pm; could not move; did not feel her self all next day; headache so bad induced vomiting; chills; fever for 3 days; had 2 really bad head colds; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move) and FEELING ABNORMAL (did not feel her self all next day) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Allergy. Concomitant products included MELOXICAM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced NASOPHARYNGITIS (had 2 really bad head colds). On 17-Mar-2021, the patient experienced ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move), FEELING ABNORMAL (did not feel her self all next day), HEADACHE (headache so bad induced vomiting), CHILLS (chills) and PYREXIA (fever for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move), FEELING ABNORMAL (did not feel her self all next day), NASOPHARYNGITIS (had 2 really bad head colds), HEADACHE (headache so bad induced vomiting), CHILLS (chills) and PYREXIA (fever for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Allergy pills for an unknown indication.