chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pneumonia, Pyrexia
Clinical narrative: Systemic: pneumonia-Mild, Additional Details: Per pt's wife, pt started feeling bad on 8/1/21 and ran a fever of 102. Pt went to doctor on 8/3/21 and was diagnosised with pneumonia. Pt is asymptomatic per wife and received antibiotics.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Mild
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Headache, Lethargy, Syncope
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted upon minutes after patient given vaccine. Pt was going by seat to sit down after getting vaccinated and brother was on deck for the vaccine. Before sitting down pt fainted and hit the floor. Patient was unresponsive for a few seconds and then recovered. Pt was complaining about headaches but reported to be okay. Asked pt and father multiple times if they were okay, they said they were fine. Pt sat for observation for 15 minutes and then left the pharmacy, fine.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted upon minutes after patient given vaccine. Pt was going by seat to sit down after getting vaccinated and brother was on deck for the vaccine. Before sitting down pt fainted and hit the floor. Patient was unresponsive for a few seconds and then recovered. Pt was complaining about headaches but reported to be okay. Asked pt and father multiple times if they were okay, they said they were fine. Pt sat for observation for 15 minutes and then left the pharmacy, fine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Lip swelling
Clinical narrative: her lips were swollen; chills; headache; fatigue; blotching redness on her arm; little bit of itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (her lips were swollen), ERYTHEMA (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (blotching redness on her arm) and PRURITUS (little bit of itching). On an unknown date, the patient experienced LIP SWELLING (her lips were swollen), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Chills, Headache, Fatigue and Temperature elevation, at a dose of 200 mg once. On 21-Feb-2021, ERYTHEMA (blotching redness on her arm) and PRURITUS (little bit of itching) had resolved. At the time of the report, LIP SWELLING (her lips were swollen) outcome was unknown and CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reportedly, 3 weeks after being vaccinated, the patient stated started experiencing chills, headache, fatigue, and little bit of temperature, which resolved following treatment with ibuprofen. The patient questioned herself if this could be a delayed reaction from the vaccine or is this common and wanted to due diligence by reporting this to Moderna. Concomitant medications were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: her lips were swollen; chills; headache; fatigue; blotching redness on her arm; little bit of itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (her lips were swollen), ERYTHEMA (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (blotching redness on her arm) and PRURITUS (little bit of itching). On an unknown date, the patient experienced LIP SWELLING (her lips were swollen), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Chills, Headache, Fatigue and Temperature elevation, at a dose of 200 mg once. On 21-Feb-2021, ERYTHEMA (blotching redness on her arm) and PRURITUS (little bit of itching) had resolved. At the time of the report, LIP SWELLING (her lips were swollen) outcome was unknown and CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reportedly, 3 weeks after being vaccinated, the patient stated started experiencing chills, headache, fatigue, and little bit of temperature, which resolved following treatment with ibuprofen. The patient questioned herself if this could be a delayed reaction from the vaccine or is this common and wanted to due diligence by reporting this to Moderna. Concomitant medications were not reported.   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Injection site reaction, Oropharyngeal pain, Pain
Clinical narrative: Body aches, my right arm where I got the injection is feels heavy, swollen feet, sore throat and tiredness.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Body aches, my right arm where I got the injection is feels heavy, swollen feet, sore throat and tiredness.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient (documentation in system)-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient reported pain and swelling at injection site. Swelling decreased within the hour but she was concerned because it hurt more than first dose. She declined follow up with MD, although RPh recommended follow up since patient was concerned.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Hallucination, Lethargy, Pain
Clinical narrative: Had several hours of chills/shivering, followed by several hours of being extremely hot with some hallucinations.  Fever with body aches from head to toe.  Extremely lethargic for 24 hours or so.  Still not back to 100% energy level, but getting close.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Had several hours of chills/shivering, followed by several hours of being extremely hot with some hallucinations.  Fever with body aches from head to toe.  Extremely lethargic for 24 hours or so.  Still not back to 100% energy level, but getting close.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral, Throat irritation
Clinical narrative: Onset of numbness/tingling in lips was around 4 hours later after receiving shot.  Numbness area expanded around 35 hours later to throat mouth area.  Numbness/swelling continues to irritate throat/lips area persists with feeling of little swelling, but not impacting any breathing.  I continue to monitor and plan on going to a dr if breathing becomes compromised, if symptoms remain the same - I will notify my doctor Monday morning for documentation purposes and advice on if I should receive 2nd shot?
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: mild, consistent and persistent itching all over his body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (mild, consistent and persistent itching all over his body) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (mild, consistent and persistent itching all over his body). At the time of the report, PRURITUS (mild, consistent and persistent itching all over his body) outcome was unknown.        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.   Reportedly, the patient already reached out to Centers for Disease Control and Prevention (CDC) to ask if he can proceed with the 2nd dose after experiencing these symptoms and CDC advised him not to proceed with it. He called to get Moderna's recommendation on his situation before going to his healthcare provider for advise. Concomitant medications and treatment details were not reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient complained of numbness in lower extremeties on the inside of both legs from knee down. Denies any previous injury or surgery or inflammation in that area. I did not want to give dosage 2 until we have knowledge of what may have occured and someone confirms that he is well enough to receive.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: 7 days after injection, injection site developed a welt. The welt was tender, hot to the touch, swollen and itchy.  14 days after the injection, a red circle has developed. The circle is hot to the touch and tender.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Urticaria
Clinical narrative: 7 days after injection, injection site developed a welt. The welt was tender, hot to the touch, swollen and itchy.  14 days after the injection, a red circle has developed. The circle is hot to the touch and tender.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hypertension
Clinical narrative: Systemic: Chills-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Additional Details: AFTER 15 MINUTES PT GOT UP AND STARTED NOT FELLING GOOD. BLOOD PRESSURE 215/182.. TAKEN AGAIN 205/180.. DAUGHTER CALLED AMBULANCE. SHE DECIDED NOT TO GO AFTER HER DAUGHTER BROUGHT HER HCTZ. WILL CALL MONDAY TO FOLLOW UP.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Systemic: Knot developed on right wrist approximately 2-3 hours after administration.-Mild
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash at injection site
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: face numbness-Mild
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle tightness, Paraesthesia
Clinical narrative: Systemic: jaw tightness-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: experienced numbness and tingling from left shoulder down to left hand
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Colitis ischaemic, Colon adenoma, Colonoscopy abnormal, Constipation
Clinical narrative: The day after I got my 2nd shot, I felt really sick. I was dizzy, nauseous, extremely fatigued to where I almost passed out a couple times. My biggest concern was the fatigue and my blood pressure tanking. It got down to 90/60. The issue is that for the months following I had really bad gastrointestinal issues. I was constipated at times, and had diarrhea at other times, going about 8-10 times before it even hit noon (my average before this was once a day or not at all). I was dehydrated from using the bathroom so much so I was dizzy nauseous, light-headed, and fatigued constantly. I had a lot of abdomen pain and soreness. All of these symptoms occured after I got my 2nd dose and have continued until this very day. I went to my primary doctor in May/June, but she believed that I was having too many unrelated symptoms and that it was probably something I was eating (since I do have a few food allergies). I basically wasn?t having it and I went to get a second opinion at a diagnostic gastrointestinal doctor. I got a colonoscopy and endoscopy from him back in July and  it was concluded that I had an ulcer in my colon, among other things like a polyp (also in my colon), gastritis, esophagitis, and internal hemorrhoids. Now the only one that is really important to this story, however, is the ulcer. I was told by the doctor?s assistant in my follow up appointment that I also have ischemic colitis and that that was how my ulcer was most likely formed- just having a drop in blood pressure for an extended period of time, not getting enough blood flow to my colon, causing an ulcer. She told me the ulcer will heal as my blood pressure rises, but I?m my whole life I?ve always had lower than average blood pressure so it can?t get high enough and I?m in a bit of a pickle.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Diarrhoea, Dizziness, Endoscopy abnormal, Fatigue
Clinical narrative: The day after I got my 2nd shot, I felt really sick. I was dizzy, nauseous, extremely fatigued to where I almost passed out a couple times. My biggest concern was the fatigue and my blood pressure tanking. It got down to 90/60. The issue is that for the months following I had really bad gastrointestinal issues. I was constipated at times, and had diarrhea at other times, going about 8-10 times before it even hit noon (my average before this was once a day or not at all). I was dehydrated from using the bathroom so much so I was dizzy nauseous, light-headed, and fatigued constantly. I had a lot of abdomen pain and soreness. All of these symptoms occured after I got my 2nd dose and have continued until this very day. I went to my primary doctor in May/June, but she believed that I was having too many unrelated symptoms and that it was probably something I was eating (since I do have a few food allergies). I basically wasn?t having it and I went to get a second opinion at a diagnostic gastrointestinal doctor. I got a colonoscopy and endoscopy from him back in July and  it was concluded that I had an ulcer in my colon, among other things like a polyp (also in my colon), gastritis, esophagitis, and internal hemorrhoids. Now the only one that is really important to this story, however, is the ulcer. I was told by the doctor?s assistant in my follow up appointment that I also have ischemic colitis and that that was how my ulcer was most likely formed- just having a drop in blood pressure for an extended period of time, not getting enough blood flow to my colon, causing an ulcer. She told me the ulcer will heal as my blood pressure rises, but I?m my whole life I?ve always had lower than average blood pressure so it can?t get high enough and I?m in a bit of a pickle.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastritis, Gastrointestinal disorder, Haemorrhoids, Large intestinal ulcer, Nausea
Clinical narrative: The day after I got my 2nd shot, I felt really sick. I was dizzy, nauseous, extremely fatigued to where I almost passed out a couple times. My biggest concern was the fatigue and my blood pressure tanking. It got down to 90/60. The issue is that for the months following I had really bad gastrointestinal issues. I was constipated at times, and had diarrhea at other times, going about 8-10 times before it even hit noon (my average before this was once a day or not at all). I was dehydrated from using the bathroom so much so I was dizzy nauseous, light-headed, and fatigued constantly. I had a lot of abdomen pain and soreness. All of these symptoms occured after I got my 2nd dose and have continued until this very day. I went to my primary doctor in May/June, but she believed that I was having too many unrelated symptoms and that it was probably something I was eating (since I do have a few food allergies). I basically wasn?t having it and I went to get a second opinion at a diagnostic gastrointestinal doctor. I got a colonoscopy and endoscopy from him back in July and  it was concluded that I had an ulcer in my colon, among other things like a polyp (also in my colon), gastritis, esophagitis, and internal hemorrhoids. Now the only one that is really important to this story, however, is the ulcer. I was told by the doctor?s assistant in my follow up appointment that I also have ischemic colitis and that that was how my ulcer was most likely formed- just having a drop in blood pressure for an extended period of time, not getting enough blood flow to my colon, causing an ulcer. She told me the ulcer will heal as my blood pressure rises, but I?m my whole life I?ve always had lower than average blood pressure so it can?t get high enough and I?m in a bit of a pickle.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oesophagitis, Presyncope, Sick relative
Clinical narrative: The day after I got my 2nd shot, I felt really sick. I was dizzy, nauseous, extremely fatigued to where I almost passed out a couple times. My biggest concern was the fatigue and my blood pressure tanking. It got down to 90/60. The issue is that for the months following I had really bad gastrointestinal issues. I was constipated at times, and had diarrhea at other times, going about 8-10 times before it even hit noon (my average before this was once a day or not at all). I was dehydrated from using the bathroom so much so I was dizzy nauseous, light-headed, and fatigued constantly. I had a lot of abdomen pain and soreness. All of these symptoms occured after I got my 2nd dose and have continued until this very day. I went to my primary doctor in May/June, but she believed that I was having too many unrelated symptoms and that it was probably something I was eating (since I do have a few food allergies). I basically wasn?t having it and I went to get a second opinion at a diagnostic gastrointestinal doctor. I got a colonoscopy and endoscopy from him back in July and  it was concluded that I had an ulcer in my colon, among other things like a polyp (also in my colon), gastritis, esophagitis, and internal hemorrhoids. Now the only one that is really important to this story, however, is the ulcer. I was told by the doctor?s assistant in my follow up appointment that I also have ischemic colitis and that that was how my ulcer was most likely formed- just having a drop in blood pressure for an extended period of time, not getting enough blood flow to my colon, causing an ulcer. She told me the ulcer will heal as my blood pressure rises, but I?m my whole life I?ve always had lower than average blood pressure so it can?t get high enough and I?m in a bit of a pickle.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: broke out in whelps all over her body; swollen lips; A spontaneous report  was received from a consumer concerning a 67-year old, female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and broke out in welts all over her body.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On an unknown date, the patient broke out in welts (reported as whelps) all over her body.Treatment details included diphenhydramine hydrochloride, and famotidine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, broke out in whelps all over her body,was unknown.; Reporter'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: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: 11 hours after vaccine developed very high fever 39.3 C, chills, feeling nauseous
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Flushing, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient has a fear of needles.  Reported always having trouble in past when giving blood.  Patient felt flushed within a minute afterward.  She also began to feel nauseaous and vomited some.  She felt some stomach pain as well.  She sat for nearly 30 minutes and felt better over time.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling extremeties
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Extreme soreness at site of injection. Significant weakness in both legs.  Achiness in both legs, particularly from knees down.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: water like feeling in skin
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Paraesthesia, Rash
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: water like feeling in skin
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: water like feeling in skin
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: water like feeling in skin
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Sensory disturbance
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: water like feeling in skin
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Pain
Clinical narrative: Bad body aches, freezing cold, mild headache , tiredness
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea
Clinical narrative: Extreme chills the first evening and progressed to extreme difficulty breathing and chest pains.  I assumed it was the vaccine doing its job to build up my immunity.  So I didn't head to the hospital until my breathing was extremely labored.  At the hospital I was diagnosed with DVT in left leg and multiple pulmonary embolisms in both lungs. I had a very large blood clot in my left lung.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Pulmonary thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Extreme chills the first evening and progressed to extreme difficulty breathing and chest pains.  I assumed it was the vaccine doing its job to build up my immunity.  So I didn't head to the hospital until my breathing was extremely labored.  At the hospital I was diagnosed with DVT in left leg and multiple pulmonary embolisms in both lungs. I had a very large blood clot in my left lung.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site laceration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash at the injection site; Redness at the injection site; Raised at the injection site; Broke out at the injection site; Itchiness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE LACERATION (Broke out at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Raised at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (History of anaphylactic reaction to bug bite and medication). Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Acid reflux (oesophageal).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE LACERATION (Broke out at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Raised at the injection site). On 19-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Vaccination site rash, Vaccination site erythema, Vaccination site laceration, Vaccination site swelling and Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE LACERATION (Broke out at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Raised at the injection site) 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.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Feeling abnormal, Lymphadenopathy, Migraine
Clinical narrative: Severe Migraine; Swollen Lymph node; foggy brain; ear pain; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe Migraine), LYMPHADENOPATHY (Swollen Lymph node), FEELING ABNORMAL (foggy brain), EAR PAIN (ear pain) and FATIGUE (fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe Migraine), LYMPHADENOPATHY (Swollen Lymph node), FEELING ABNORMAL (foggy brain), EAR PAIN (ear pain) and FATIGUE (fatigue). At the time of the report, MIGRAINE (Severe Migraine), LYMPHADENOPATHY (Swollen Lymph node), FEELING ABNORMAL (foggy brain), EAR PAIN (ear pain) and FATIGUE (fatigue) 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.   Treatment details were not provided
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Insomnia, Peripheral swelling, Tremor
Clinical narrative: Swollen arm; felt hyper; could not sleep; Hand little shaky; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), AGITATION (felt hyper), INSOMNIA (could not sleep) and TREMOR (Hand little shaky) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZIA) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), AGITATION (felt hyper), INSOMNIA (could not sleep) and TREMOR (Hand little shaky). At the time of the report, PERIPHERAL SWELLING (Swollen arm), AGITATION (felt hyper), INSOMNIA (could not sleep) and TREMOR (Hand little shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to know if his symptoms were expected and mentioned that he was not going to take the second dose. The patient was angry and frustrated. Treatment details and concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Autoscopy, Back pain, Feeling abnormal, Hand deformity, Presyncope
Clinical narrative: back ache; felt like I had the flu; felt like I was going to pass out; weird feeling; out of body experience; hands feel weird as if they did not belong to me; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (back ache), FEELING ABNORMAL (felt like I had the flu), PRESYNCOPE (felt like I was going to pass out), FEELING ABNORMAL (weird feeling) and AUTOSCOPY (out of body experience) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M-20A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (back ache), FEELING ABNORMAL (felt like I had the flu), PRESYNCOPE (felt like I was going to pass out), FEELING ABNORMAL (weird feeling), AUTOSCOPY (out of body experience) and HAND DEFORMITY (hands feel weird as if they did not belong to me). At the time of the report, BACK PAIN (back ache), FEELING ABNORMAL (felt like I had the flu), PRESYNCOPE (felt like I was going to pass out), FEELING ABNORMAL (weird feeling), AUTOSCOPY (out of body experience) and HAND DEFORMITY (hands feel weird as if they did not belong to me) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment details were not provided.   This case was linked to MOD-2021-034856 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: big lump on arm; red round circle on arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (big lump on arm) and VACCINATION SITE ERYTHEMA (red round circle on arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE INDURATION (big lump on arm) and VACCINATION SITE ERYTHEMA (red round circle on arm). At the time of the report, VACCINATION SITE INDURATION (big lump on arm) and VACCINATION SITE ERYTHEMA (red round circle on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details and concomitant medications were not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pruritus, Rash macular
Clinical narrative: chills; headache; fatigue; blotching redness on her arm; little bit of itching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH MACULAR (blotching redness on her arm) and PRURITUS (little bit of itching). On 03-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with IBUPROFEN 03-Mar-2021 for Chills, Headache, Fatigue and Temperature elevation, at a dose of 200 mg, 1 tablet. At the time of the report, RASH MACULAR (blotching redness on her arm), PRURITUS (little bit of itching), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient reported that on 03-Mar-2021, she experienced little bit of temperature (body temperature not reported). She confirmed that following treatment with ibuprofen, she felt completely fine. Patient wanted to due diligence by reporting this to Moderna. No further details were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: large lump under chin. She describes the lump size as a golf ball; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (large lump under chin. She describes the lump size as a golf ball) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced SWELLING (large lump under chin. She describes the lump size as a golf ball). At the time of the report, SWELLING (large lump under chin. She describes the lump size as a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment details were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain a couple days after vaccine; Arm swelling a couple days after vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain a couple days after vaccine) and PERIPHERAL SWELLING (Arm swelling a couple days after vaccine) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain a couple days after vaccine) and PERIPHERAL SWELLING (Arm swelling a couple days after vaccine). The patient was treated with MENTHOL (BIOFREEZE PAIN RELIEVING) ongoing since an unknown date for Pain and Swelling, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain a couple days after vaccine) and PERIPHERAL SWELLING (Arm swelling a couple days after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. The patient's friend reported that patient had some arm swelling and pain a couple days after receiving the Moderna COVID-19 vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm; upset stomach; nausea; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL DISCOMFORT (upset stomach), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.            The patient reported that he had an increase in his PSA level (details not provided). He wanted to confirm if he could take Tylenol for his symptoms? Concomitant medications and treatment details were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Vaccination site discomfort
Clinical narrative: Discomfort at the site; Burning up with a 103; She didn't sleep very well; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She didn't sleep very well), VACCINATION SITE DISCOMFORT (Discomfort at the site) and PYREXIA (Burning up with a 103) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (She didn't sleep very well). On 07-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the site) and PYREXIA (Burning up with a 103). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Feb-2021, INSOMNIA (She didn't sleep very well) had resolved. On 09-Feb-2021, VACCINATION SITE DISCOMFORT (Discomfort at the site) and PYREXIA (Burning up with a 103) had resolved.            No Concomitant product use was reported.  Treatment medication included Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-050384 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Mass, Nausea, Rash macular
Clinical narrative: was not eating; nausea and vomiting; nausea and vomiting; excruciating pain on her left shoulder arm, elbow down to her hand; lump above her left elbow; 3 red spots on her left arm which now appear like bruises; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump above her left elbow), RASH MACULAR (3 red spots on her left arm which now appear like bruises), DECREASED APPETITE (was not eating), VOMITING (nausea and vomiting) and NAUSEA (nausea and vomiting) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MexA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced MASS (lump above her left elbow), RASH MACULAR (3 red spots on her left arm which now appear like bruises) and ARTHRALGIA (excruciating pain on her left shoulder arm, elbow down to her hand). On an unknown date, the patient experienced DECREASED APPETITE (was not eating), VOMITING (nausea and vomiting) and NAUSEA (nausea and vomiting). The patient was treated with PARACETAMOL (TYNELOL) ongoing since an unknown date for Arthralgia, Mass, Nausea, Vomiting and Rash macular, at an unspecified dose and frequency. At the time of the report, MASS (lump above her left elbow), RASH MACULAR (3 red spots on her left arm which now appear like bruises), DECREASED APPETITE (was not eating), VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting) and ARTHRALGIA (excruciating pain on her left shoulder arm, elbow down to her hand) outcome was unknown.        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.   Concomitant medications were not reported.