chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Next day about same time of vaccination, runny nose for about three hours then gone. Feeling almost normal. Almost no pain on the harm. The day after at about ten PM feeling really tired, cold chills, Went to bed and couldn't sleep almost all night. Hot chicken veg soup helped. Couldn't never get rid of really bad headache, sore neck, extreme fatigue, foggy mind.  A few scattered and small red spots on skin. Not getting bigger nor smaller. Occasional chills but no fever 36.2 C to 37.2 C max at one point. Tingling skin and occasional numbness on hands and fingers. At one point today the hands turned white and tingly then back to normal. About 15 minutes earlier I took to baby aspirins with plenty of water. It worked on the headache but it may have been responsible for the whyte cold and tingly hands. The skin on the forearms also turned almost violet and then back to normal within about ten minutes. How long are these side effects supposed to last? I haven't been able to work. We are on day four.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Neck pain, Pain in extremity, Paraesthesia, Rash macular
Clinical narrative: Next day about same time of vaccination, runny nose for about three hours then gone. Feeling almost normal. Almost no pain on the harm. The day after at about ten PM feeling really tired, cold chills, Went to bed and couldn't sleep almost all night. Hot chicken veg soup helped. Couldn't never get rid of really bad headache, sore neck, extreme fatigue, foggy mind.  A few scattered and small red spots on skin. Not getting bigger nor smaller. Occasional chills but no fever 36.2 C to 37.2 C max at one point. Tingling skin and occasional numbness on hands and fingers. At one point today the hands turned white and tingly then back to normal. About 15 minutes earlier I took to baby aspirins with plenty of water. It worked on the headache but it may have been responsible for the whyte cold and tingly hands. The skin on the forearms also turned almost violet and then back to normal within about ten minutes. How long are these side effects supposed to last? I haven't been able to work. We are on day four.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Skin discolouration, Sleep disorder
Clinical narrative: Next day about same time of vaccination, runny nose for about three hours then gone. Feeling almost normal. Almost no pain on the harm. The day after at about ten PM feeling really tired, cold chills, Went to bed and couldn't sleep almost all night. Hot chicken veg soup helped. Couldn't never get rid of really bad headache, sore neck, extreme fatigue, foggy mind.  A few scattered and small red spots on skin. Not getting bigger nor smaller. Occasional chills but no fever 36.2 C to 37.2 C max at one point. Tingling skin and occasional numbness on hands and fingers. At one point today the hands turned white and tingly then back to normal. About 15 minutes earlier I took to baby aspirins with plenty of water. It worked on the headache but it may have been responsible for the whyte cold and tingly hands. The skin on the forearms also turned almost violet and then back to normal within about ten minutes. How long are these side effects supposed to last? I haven't been able to work. We are on day four.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: Rash, itchiness, hives, redness around the jab location.  Upper part,  left shoulder.  Consistent for 2 weeks after the shot. Size - oval or drop like shape, about 3x1.5 in. No treatment applied.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin, Blood albumin increased, Blood creatinine, Blood creatinine increased, Neutrophil count
Clinical narrative: Elevated albumin/SCR; Elevated albumin/SCR; Elevated Neutrophil count; A spontaneous report  was received from a  concerning a consumer concerning a 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, elevated albumin/SCR / blood albumin increased / blood creatinine increased and elevated neutrophil count / neutrophil count increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient had a blood work done. On an unknown date, the patient had an elevated albumin, SCR and neutrophil.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events elevated albumin/SCR and elevated neutrophil count was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil count increased
Clinical narrative: Elevated albumin/SCR; Elevated albumin/SCR; Elevated Neutrophil count; A spontaneous report  was received from a  concerning a consumer concerning a 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, elevated albumin/SCR / blood albumin increased / blood creatinine increased and elevated neutrophil count / neutrophil count increased.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient had a blood work done. On an unknown date, the patient had an elevated albumin, SCR and neutrophil.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events elevated albumin/SCR and elevated neutrophil count was unknown.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Coordination abnormal, Dyspnoea, Electrocardiogram normal, Gait disturbance
Clinical narrative: Went to the ER several days after shot after experiencing chest pain and difficulty breathing... tests came out fine and started to feel better.  Two weeks later, started experiencing tingling and pins/needles in feet. That sensation slowly shot up my entire body and had trouble walking and coordination was off in a major way. Started having major pain across body. When it felt like it was becoming too much and I needed to go to ER, it slowly started reversing over the course of 4-5 days. Now, I'm 90% recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Went to the ER several days after shot after experiencing chest pain and difficulty breathing... tests came out fine and started to feel better.  Two weeks later, started experiencing tingling and pins/needles in feet. That sensation slowly shot up my entire body and had trouble walking and coordination was off in a major way. Started having major pain across body. When it felt like it was becoming too much and I needed to go to ER, it slowly started reversing over the course of 4-5 days. Now, I'm 90% recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Received rash, hard bump, redness, and itching at injection site on Day 7 following injection. Also experienced headache and dizziness minutes after receiving injection on site. Extreme fatigue lasting days, but seemed to improve  by Day 6. Vestibular Condition - Meniere's Disease - Tinnitus started to occur and is still ongoing on Day 8.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling, Meniere's disease
Clinical narrative: Received rash, hard bump, redness, and itching at injection site on Day 7 following injection. Also experienced headache and dizziness minutes after receiving injection on site. Extreme fatigue lasting days, but seemed to improve  by Day 6. Vestibular Condition - Meniere's Disease - Tinnitus started to occur and is still ongoing on Day 8.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus, Vestibular disorder
Clinical narrative: Received rash, hard bump, redness, and itching at injection site on Day 7 following injection. Also experienced headache and dizziness minutes after receiving injection on site. Extreme fatigue lasting days, but seemed to improve  by Day 6. Vestibular Condition - Meniere's Disease - Tinnitus started to occur and is still ongoing on Day 8.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Brain stem auditory evoked response abnormal, Chills, Condition aggravated, Deafness unilateral
Clinical narrative: AFTER FIRST DOSE 20 APRIL 2021:  After first dost, had pain in my left arm for 3 days and it got better in a week time. PROBLEM-1, my left ear started little ringing.  PROBLEM-2, my right foot have problem in walking. Initially thought it is my old shoes but after changing to new shoes problem still persist.    AFTER SECOND DOSE 18 MAY 2021:  Heavy shivering, fever, body pain, pain in right arm 3 days then started getting better and got these conditions improved in 7-10 days.  PROBLEM-1, Ear ringing, buzzing, hollow sound, unable to recognize surround sound problem and listening capabilities in left ear reduced heavily.  PROBLEM-2: Right leg problem increased and feeling numbness and tickling on right foot. I could
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: AFTER FIRST DOSE 20 APRIL 2021:  After first dost, had pain in my left arm for 3 days and it got better in a week time. PROBLEM-1, my left ear started little ringing.  PROBLEM-2, my right foot have problem in walking. Initially thought it is my old shoes but after changing to new shoes problem still persist.    AFTER SECOND DOSE 18 MAY 2021:  Heavy shivering, fever, body pain, pain in right arm 3 days then started getting better and got these conditions improved in 7-10 days.  PROBLEM-1, Ear ringing, buzzing, hollow sound, unable to recognize surround sound problem and listening capabilities in left ear reduced heavily.  PROBLEM-2: Right leg problem increased and feeling numbness and tickling on right foot. I could
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: AFTER FIRST DOSE 20 APRIL 2021:  After first dost, had pain in my left arm for 3 days and it got better in a week time. PROBLEM-1, my left ear started little ringing.  PROBLEM-2, my right foot have problem in walking. Initially thought it is my old shoes but after changing to new shoes problem still persist.    AFTER SECOND DOSE 18 MAY 2021:  Heavy shivering, fever, body pain, pain in right arm 3 days then started getting better and got these conditions improved in 7-10 days.  PROBLEM-1, Ear ringing, buzzing, hollow sound, unable to recognize surround sound problem and listening capabilities in left ear reduced heavily.  PROBLEM-2: Right leg problem increased and feeling numbness and tickling on right foot. I could
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle tightness, Pain in jaw, Paraesthesia
Clinical narrative: By 8 hours post vax facial tingling. By 9 hours, some numbness to the nose and chin. Some pain or tightness to the lower jaw.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Disorientation, Dizziness
Clinical narrative: Heavy vaginal bleeding for 6+ days with blood clots 3-4 inches long/ wide with disorientation, dizziness, pain radiating from right hip to the back of right knee, lower back pain, abdominal cramps. Treatment: progesterone medication Outcome: vaccine reaction
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Pain, Pregnancy test, Thrombosis, Ultrasound scan
Clinical narrative: Heavy vaginal bleeding for 6+ days with blood clots 3-4 inches long/ wide with disorientation, dizziness, pain radiating from right hip to the back of right knee, lower back pain, abdominal cramps. Treatment: progesterone medication Outcome: vaccine reaction
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Heavy vaginal bleeding for 6+ days with blood clots 3-4 inches long/ wide with disorientation, dizziness, pain radiating from right hip to the back of right knee, lower back pain, abdominal cramps. Treatment: progesterone medication Outcome: vaccine reaction
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Pruritus, Rash, Rash papular, Scab
Clinical narrative: Swollen earlobe and raised bumps behind left ear. Turned scabby and purple after a few days, then itchy red welts appeared on neck and chest. Treated with cortisone cream. Rashes persisted for about 8 days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Swollen earlobe and raised bumps behind left ear. Turned scabby and purple after a few days, then itchy red welts appeared on neck and chest. Treated with cortisone cream. Rashes persisted for about 8 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 3rd dose of Pfizer after denying ever receiving the vaccines series prior.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Influenza like illness
Clinical narrative: Headache and fatigue , extreme feeling of heat with no fever . Feel like I have the flu with no other symptoms.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Headache, Sensory disturbance
Clinical narrative: I have a horrible headache like I?ve never had before and my chest on my left side feels really tight and I have a watery pain sensation right under.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Tenderness at the injection site.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 INJECTION SITE PAIN (Tenderness at the injection site.). At the time of the report, INJECTION SITE PAIN (Tenderness at the injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Injection site rash
Clinical narrative: Rash developed at the injection site more than a week after receiving the shot. Conjunctivitis developed the next day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Pain in extremity
Clinical narrative: arm was in pain; head felt funny; she felt off for a few days; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm was in pain), FEELING ABNORMAL (head felt funny) and DEPRESSED MOOD (she felt off for a few days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was in pain), FEELING ABNORMAL (head felt funny) and DEPRESSED MOOD (she felt off for a few days). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was in pain), FEELING ABNORMAL (head felt funny) and DEPRESSED MOOD (she felt off for a few days) had resolved.        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.   Patient reported that she did not took any medications post dose 1.  No treatment information was provided.  No concomitant medication was provided.     This case was linked to MOD-2021-019076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: This follow-up was received on 25-MAY-2021 which did not update any new information.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness
Clinical narrative: Feeling a cold tingly feeling in both of his legs; Feeling a cold tingly feeling in both of his legs; A spontaneous report was received from a consumer , other healthcare professional and the consumer  was also a 86-years-old male patient who received Moderna's COVID-19 vaccine and experienced a  cold tingly feeling in both of his legs.  Patient's medical history and concomitant medication list was not provided.  On 13-JAN-2021, patient received  Moderna's COVID-19 vaccine in his left arm .  On an unknown date ,about a week later the patient started feeling a cold tingly feeling in both of his legs. Symptoms are ongoing.  Treatment actions not provided.  Action taken with mRNA-1273 was not provided.  The outcome of events, started feeling a cold tingly feeling in both of his legs.was not recovered/resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the event, diarrhea. Treatment details included Pepto-Bismol tablet. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, diarrhea was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pain of skin
Clinical narrative: Headache; The injection site was very painful; Fever of 101; don't feel good/not feeling well; her skin hurt; with a pins and needles sensation; her whole body was in pain/achy; Chills; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (don't feel good/not feeling well), PAIN OF SKIN (her skin hurt), PARAESTHESIA (with a pins and needles sensation), PAIN (her whole body was in pain/achy) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021 at 2:20 AM, the patient experienced VACCINATION COMPLICATION (don't feel good/not feeling well), PAIN OF SKIN (her skin hurt), PARAESTHESIA (with a pins and needles sensation), PAIN (her whole body was in pain/achy), CHILLS (Chills), VACCINATION SITE PAIN (The injection site was very painful) and PYREXIA (Fever of 101). On 21-Feb-2021 at 2:45 PM, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 20-Feb-2021 at a dose of At 3:30AM took 2, another two at 8:30AM. On 21-Feb-2021 at 2:45 PM, CHILLS (Chills) and PYREXIA (Fever of 101) had resolved. At the time of the report, VACCINATION COMPLICATION (don't feel good/not feeling well), PAIN OF SKIN (her skin hurt), PARAESTHESIA (with a pins and needles sensation), PAIN (her whole body was in pain/achy), HEADACHE (Headache) and VACCINATION SITE PAIN (The injection site was very painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101 (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications are not provided.   This case was linked to MOD-2021-019071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up document was received. Adverse event outcome was updated to recovered/resolved. It contains significant information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination complication, Vaccination site pain
Clinical narrative: Headache; The injection site was very painful; Fever of 101; don't feel good/not feeling well; her skin hurt; with a pins and needles sensation; her whole body was in pain/achy; Chills; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (don't feel good/not feeling well), PAIN OF SKIN (her skin hurt), PARAESTHESIA (with a pins and needles sensation), PAIN (her whole body was in pain/achy) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021 at 2:20 AM, the patient experienced VACCINATION COMPLICATION (don't feel good/not feeling well), PAIN OF SKIN (her skin hurt), PARAESTHESIA (with a pins and needles sensation), PAIN (her whole body was in pain/achy), CHILLS (Chills), VACCINATION SITE PAIN (The injection site was very painful) and PYREXIA (Fever of 101). On 21-Feb-2021 at 2:45 PM, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 20-Feb-2021 at a dose of At 3:30AM took 2, another two at 8:30AM. On 21-Feb-2021 at 2:45 PM, CHILLS (Chills) and PYREXIA (Fever of 101) had resolved. At the time of the report, VACCINATION COMPLICATION (don't feel good/not feeling well), PAIN OF SKIN (her skin hurt), PARAESTHESIA (with a pins and needles sensation), PAIN (her whole body was in pain/achy), HEADACHE (Headache) and VACCINATION SITE PAIN (The injection site was very painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 101 (High) 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications are not provided.   This case was linked to MOD-2021-019071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up document was received. Adverse event outcome was updated to recovered/resolved. It contains significant information.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: had an immediate reaction in regards to a fast heartbeat; A spontaneous report was received from a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, fast heartbeat Ever since she got the vaccine, she had an immediate reaction in regards to a fast heartbeat, but notes that her heartrate has been high still following the vaccination.    The patient's medical history were not provided.   Relevant concomitant medication were not provided.   On 23Jan2021 prior to the onset of the events, fast heartbeat, the patient received their mRNA-1273 (lot/batch: not provided) Implant route for prophylaxis of COVID-19 infection.    Laboratory details were not provided .    She took no medications in regards to her reaction.  Action taken with mRNA-1273 in response to the events was not reported.      The outcome of  reported event, fast heartbeat was recovering/resolving.  The reporter assessment for the event(s) fast heartbeat was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site itching; rash at injection site; injection site redness 5x2 inches; A spontaneous report was received from a reporter like consumer concerning an unspecified year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on the injection site, redness 5x2 inches at injection site and injection site itching.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, prior to receiving mRNA-1273, the patient felt rash on the injection site, redness 5x2 inches at injection site and injection site itching.  No lab details were provided.  Treatment for the events were benadryl and hydrocortisone.  Action taken with mRNA-1273 in response to the events was not reported.   The events, rash on the injection site, redness 5x2 inches at injection site and injection site itching was unknown.  Recoded events (Vaccination site pruritus, Vaccination site erythema, Vaccination site rash)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Feeling abnormal; Headache; Chills; Her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm was sore). On 20-Feb-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling abnormal). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 21-Feb-2021, CHILLS (Chills) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Her arm was sore), FEELING ABNORMAL (Feeling abnormal) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hyposmia, Taste disorder
Clinical narrative: Change in taste; Sense of smell diminished; A spontaneous report was received from a consumer concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events change in taste / taste disorder and sense of smell diminished / hyposmia.  The patient's medical history was not provided. Concomitant medications reported were linaclotide, amlodipine, CBD oil, ezetimibe, finasteride, gabapentin, losartan, Montelukast and lorazepam for drug use for unknown indication.  On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events, change in taste and sense of smell diminished.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, change in taste and sense of smell diminished was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Diarrhoea, Lethargy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not eating), ASTHENIA (no energy), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (not feeling good, blah) and LETHARGY (lethargic and has no energy whatsoever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, CYANOCOBALAMIN (VITAMIN B12 AAA), ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN, METFORMIN, SEMAGLUTIDE (RYBELSUS) and SEMAGLUTIDE (RYBELSUS) for an unknown indication. 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 PAIN (pain in the injection site), ARTHRALGIA (soreness in the shoulder) and VACCINATION SITE PAIN (soreness in the injection site). On 17-Feb-2021, the patient experienced DECREASED APPETITE (not eating) and VACCINATION COMPLICATION (not feeling good, blah). On 18-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (throwing up). On 19-Feb-2021, the patient experienced ASTHENIA (no energy) and LETHARGY (lethargic and has no energy whatsoever). On 14-Feb-2021, VACCINATION SITE PAIN (pain in the injection site), ARTHRALGIA (soreness in the shoulder) and VACCINATION SITE PAIN (soreness in the injection site) had resolved. At the time of the report, DECREASED APPETITE (not eating), ASTHENIA (no energy), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (not feeling good, blah), LETHARGY (letargic and has no energy whatsoever) and VOMITING (throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non Significant Follow up appended.  Reporter contact information updated - mail ID provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not eating), ASTHENIA (no energy), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (not feeling good, blah) and LETHARGY (lethargic and has no energy whatsoever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, CYANOCOBALAMIN (VITAMIN B12 AAA), ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN, METFORMIN, SEMAGLUTIDE (RYBELSUS) and SEMAGLUTIDE (RYBELSUS) for an unknown indication. 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 PAIN (pain in the injection site), ARTHRALGIA (soreness in the shoulder) and VACCINATION SITE PAIN (soreness in the injection site). On 17-Feb-2021, the patient experienced DECREASED APPETITE (not eating) and VACCINATION COMPLICATION (not feeling good, blah). On 18-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and VOMITING (throwing up). On 19-Feb-2021, the patient experienced ASTHENIA (no energy) and LETHARGY (lethargic and has no energy whatsoever). On 14-Feb-2021, VACCINATION SITE PAIN (pain in the injection site), ARTHRALGIA (soreness in the shoulder) and VACCINATION SITE PAIN (soreness in the injection site) had resolved. At the time of the report, DECREASED APPETITE (not eating), ASTHENIA (no energy), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (not feeling good, blah), LETHARGY (letargic and has no energy whatsoever) and VOMITING (throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non Significant Follow up appended.  Reporter contact information updated - mail ID provided
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Feeling abnormal, Illness, Pain in extremity
Clinical narrative: Sick; Not able to eat/was just eating cereals; Threw up twice last night; Sore arm; Feel like crap/Knocked out for four days; She could not get out of the bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed), ILLNESS (Sick), FEEDING DISORDER (Not able to eat/was just eating cereals) and PAIN IN EXTREMITY (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Amantadine. Past adverse reactions to the above products included No adverse event with Amantadine. Concurrent medical conditions included Multiple sclerosis since December 1994 and Fibromyalgia since 2000. Concomitant products included PANTOPRAZOLE, DIMETHYL FUMARATE (TECFIDERA), VITAMIN B3, VITAMIN B12 [VITAMIN B12 NOS], CLONAZEPAM and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 18-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 FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed) and PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VOMITING (Threw up twice last night). On an unknown date, the patient experienced ILLNESS (Sick) and FEEDING DISORDER (Not able to eat/was just eating cereals). At the time of the report, FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed), ILLNESS (Sick), FEEDING DISORDER (Not able to eat/was just eating cereals), PAIN IN EXTREMITY (Sore arm) and VOMITING (Threw up twice last night) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included Vitamins B12 & D3. Treatment information included icing on arm for sore arm The patient thought adverse events were caused as the patient stopped taking amantadine.      Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information received on 27-Apr-2021: Reporter details, patient details, medical history, concomitant medications, update on initial adverse events and new adverse events were added. On 28-May-2021: Initial additional information received on 28-May-2021: Patient demographics, medical history, concomitant medications, and event outcome were added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sick; Not able to eat/was just eating cereals; Threw up twice last night; Sore arm; Feel like crap/Knocked out for four days; She could not get out of the bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed), ILLNESS (Sick), FEEDING DISORDER (Not able to eat/was just eating cereals) and PAIN IN EXTREMITY (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Amantadine. Past adverse reactions to the above products included No adverse event with Amantadine. Concurrent medical conditions included Multiple sclerosis since December 1994 and Fibromyalgia since 2000. Concomitant products included PANTOPRAZOLE, DIMETHYL FUMARATE (TECFIDERA), VITAMIN B3, VITAMIN B12 [VITAMIN B12 NOS], CLONAZEPAM and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 18-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 FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed) and PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced VOMITING (Threw up twice last night). On an unknown date, the patient experienced ILLNESS (Sick) and FEEDING DISORDER (Not able to eat/was just eating cereals). At the time of the report, FEELING ABNORMAL (Feel like crap/Knocked out for four days), ASTHENIA (She could not get out of the bed), ILLNESS (Sick), FEEDING DISORDER (Not able to eat/was just eating cereals), PAIN IN EXTREMITY (Sore arm) and VOMITING (Threw up twice last night) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included Vitamins B12 & D3. Treatment information included icing on arm for sore arm The patient thought adverse events were caused as the patient stopped taking amantadine.      Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional information received on 27-Apr-2021: Reporter details, patient details, medical history, concomitant medications, update on initial adverse events and new adverse events were added. On 28-May-2021: Initial additional information received on 28-May-2021: Patient demographics, medical history, concomitant medications, and event outcome were added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: Not feeling all together; A slight headache; Chills all over her body; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling all together), HEADACHE (A slight headache) and CHILLS (Chills all over her body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (Not feeling all together), HEADACHE (A slight headache) and CHILLS (Chills all over her body). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, MALAISE (Not feeling all together) and CHILLS (Chills all over her body) had resolved. At the time of the report, HEADACHE (A slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Very fatigued; Severely sick; Slept the day and night; regurgitation; Chills; Fever (101F); Muscle pain; Nausea; Vomiting; Arm was extremely sore; Could not move arm; Lethargic; Didn't want to eat; So dizzy to the point that I couldn't walk because of the dizziness; Diarrhea; Shortness of breath; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle pain / myalgia, arm was extremely sore / pain in extremity, could not move arm / limb discomfort, lethargic, didn`t want to eat / decreased appetite, so dizzy to the point that i couldn't walk because of the dizziness / dizziness, nausea, vomiting, diarrhea, shortness of breath / dyspnea, chills, fever (101f) / pyrexia, kept on regurgitating, came very close to going to the er, very fatigued, severely sick / illness and slept the day and night / hypersomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient had muscle pain, arm was extremely sore and could not move arm. On 5 Feb 2021, after receiving the second dose, the patient had same muscle pain with extremely sore arm that she could not move the arm. She also felt lethargic, didn`t wanted to eat, was so dizzy to the point that she could not walk because of dizziness, had nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating and came very close to going to the emergency room. On 6 Feb 2021, the patient was very fatigued and severely sick that she slept the day and night.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle pain, arm was extremely sore, could not move arm, lethargic, didn`t want to eat, so dizzy to the point that i couldn't walk because of the dizziness, nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating, came very close to going to the er, very fatigued, severely sick and slept the day and night was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Illness, Lethargy, Limb discomfort
Clinical narrative: Very fatigued; Severely sick; Slept the day and night; regurgitation; Chills; Fever (101F); Muscle pain; Nausea; Vomiting; Arm was extremely sore; Could not move arm; Lethargic; Didn't want to eat; So dizzy to the point that I couldn't walk because of the dizziness; Diarrhea; Shortness of breath; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle pain / myalgia, arm was extremely sore / pain in extremity, could not move arm / limb discomfort, lethargic, didn`t want to eat / decreased appetite, so dizzy to the point that i couldn't walk because of the dizziness / dizziness, nausea, vomiting, diarrhea, shortness of breath / dyspnea, chills, fever (101f) / pyrexia, kept on regurgitating, came very close to going to the er, very fatigued, severely sick / illness and slept the day and night / hypersomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient had muscle pain, arm was extremely sore and could not move arm. On 5 Feb 2021, after receiving the second dose, the patient had same muscle pain with extremely sore arm that she could not move the arm. She also felt lethargic, didn`t wanted to eat, was so dizzy to the point that she could not walk because of dizziness, had nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating and came very close to going to the emergency room. On 6 Feb 2021, the patient was very fatigued and severely sick that she slept the day and night.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle pain, arm was extremely sore, could not move arm, lethargic, didn`t want to eat, so dizzy to the point that i couldn't walk because of the dizziness, nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating, came very close to going to the er, very fatigued, severely sick and slept the day and night was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Regurgitation
Clinical narrative: Very fatigued; Severely sick; Slept the day and night; regurgitation; Chills; Fever (101F); Muscle pain; Nausea; Vomiting; Arm was extremely sore; Could not move arm; Lethargic; Didn't want to eat; So dizzy to the point that I couldn't walk because of the dizziness; Diarrhea; Shortness of breath; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle pain / myalgia, arm was extremely sore / pain in extremity, could not move arm / limb discomfort, lethargic, didn`t want to eat / decreased appetite, so dizzy to the point that i couldn't walk because of the dizziness / dizziness, nausea, vomiting, diarrhea, shortness of breath / dyspnea, chills, fever (101f) / pyrexia, kept on regurgitating, came very close to going to the er, very fatigued, severely sick / illness and slept the day and night / hypersomnia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient had muscle pain, arm was extremely sore and could not move arm. On 5 Feb 2021, after receiving the second dose, the patient had same muscle pain with extremely sore arm that she could not move the arm. She also felt lethargic, didn`t wanted to eat, was so dizzy to the point that she could not walk because of dizziness, had nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating and came very close to going to the emergency room. On 6 Feb 2021, the patient was very fatigued and severely sick that she slept the day and night.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle pain, arm was extremely sore, could not move arm, lethargic, didn`t want to eat, so dizzy to the point that i couldn't walk because of the dizziness, nausea, vomiting, diarrhea, shortness of breath, chills, fever (101f), kept on regurgitating, came very close to going to the er, very fatigued, severely sick and slept the day and night was unknown.