chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site swelling
Clinical narrative: Bump on right side of arm; Arm itch like crazy; Upper arm red through elbow and up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm itch like crazy), ERYTHEMA (Upper arm red through elbow and up) and VACCINATION SITE SWELLING (Bump on right side of arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Arm itch like crazy) and ERYTHEMA (Upper arm red through elbow and up). On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Bump on right side of arm). At the time of the report, PRURITUS (Arm itch like crazy), ERYTHEMA (Upper arm red through elbow and up) and VACCINATION SITE SWELLING (Bump on right side of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure meds, pacemaker, heart medicine for drug use for unknown indication. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vaccination site pain
Clinical narrative: Pain in the injection site; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) and ABDOMINAL PAIN UPPER (Stomach ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the injection site) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not reported. No treatment information were reported
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 diagnose after their first shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 diagnose after their first shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced COVID-19 (COVID-19 diagnose after their first shot). At the time of the report, COVID-19 (COVID-19 diagnose after their first shot) 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; rash in upper chest and shoulders in both sides; A spontaneous report was received from a consumer concerning an unmentioned-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced two small rashes and rash in upper chest and shoulders in both sides.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 21-JAN-2021, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch: unknown for prophylaxis of COVID-19 infection.  On 22-JAN-2021, The patient experienced two small rashes and rash in upper chest and shoulders in both sides.  No Laboratory details provided.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) was unknown.  The reporter assessed the event(s), [rash and rash in upper chest and shoulders], as listed to study drug.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of vaccination site pruritus (itchy sensation - near injection site), vaccination site erythema (redness - near injection site) and vaccination site swelling (swelling - near injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 004M20A) for COVID-19 immunization. Concurrent medical conditions included Parkinson's disease. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 28, 2021, patient experienced vaccination site pruritus (itchy sensation - near injection site), vaccination site erythema (redness - near injection site) and vaccination site swelling (swelling - near injection site). At the time of the report, vaccination site pruritus (itchy sensation - near injection site), vaccination site erythema (redness - near injection site) and vaccination site swelling (swelling - near injection site) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. Concomitant medications included a lot of different unspecified medications for Parkinson's disease. Treatment information not provided.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Pruritus
Clinical narrative: red puffy arm at injection site; itchy at injection site; tiredness and headache; tiredness and headache; bad chills for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red puffy arm at injection site), PRURITUS (itchy at injection site), CHILLS (bad chills for 4 days), FATIGUE (tiredness and headache) and HEADACHE (tiredness and headache) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced CHILLS (bad chills for 4 days). On 28-Jan-2021, the patient experienced ERYTHEMA (red puffy arm at injection site), PRURITUS (itchy at injection site), FATIGUE (tiredness and headache) and HEADACHE (tiredness and headache). On 22-Jan-2021, CHILLS (bad chills for 4 days) had resolved. At the time of the report, ERYTHEMA (red puffy arm at injection site), PRURITUS (itchy at injection site), FATIGUE (tiredness and headache) and HEADACHE (tiredness and headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: urticaria on her shoulder; Red; itchy; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (urticaria on her shoulder), ERYTHEMA (Red) and PRURITUS (itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 22-Jan-2021, the patient experienced URTICARIA (urticaria on her shoulder), ERYTHEMA (Red) and PRURITUS (itchy). At the time of the report, URTICARIA (urticaria on her shoulder), ERYTHEMA (Red) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Nasopharyngitis, Pain, Vaccination site pain
Clinical narrative: Cold symptoms; arm is hot, face was very hot; sore at injection site; Light headed; Sore; A spontaneous report was received from a consumer concerning herself, a 68-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced light headed/dizziness, sore/pain, cold symptoms/nasopharyngitis, arm and face hot/hot flushes, sore at the injection site/vaccination site pain.  The patient's medical history was not included . Concomitant products was not included.  On 13 Feb 2021, prior to the onset of event the patient received first dose of their two planned doses of mRNA-1273 (Batch N0:not provided) in the left arm for prophylaxis of covid 19 infection.  On 13 Feb 2021 the patient experienced light headed, and sore. On 21 Feb 2021 she began experiencing cold symptoms, arm is hot and sore at injection site. Face was very hot.  Treatment information was not included.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, light headed/dizziness, sore/pain were resolved on 13 Feb 2021, the outcome of the events, cold symptoms/nasopharyngitis, arm and face hot/hot flushes, sore at the injection site/vaccination site pain were resolved on 22 Feb 2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Hot where she got vaccinated; Redness on arm; Some discoloration; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot where she got vaccinated), VACCINATION SITE DISCOLOURATION (Some discoloration) and VACCINATION SITE ERYTHEMA (Redness on arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Some discoloration). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot where she got vaccinated) and VACCINATION SITE ERYTHEMA (Redness on arm). On 30-Jan-2021, VACCINATION SITE WARMTH (Hot where she got vaccinated) and VACCINATION SITE ERYTHEMA (Redness on arm) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Some discoloration) 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: red area 4or 5 inches below the injection site; at the beginning hurt; kind of warm to the touch; then it was itchy; disorder visual field, with some spots and with some white flashes in the field; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (disorder visual field, with some spots and with some white flashes in the field), VACCINATION SITE WARMTH (kind of warm to the touch), VACCINATION SITE PRURITUS (then it was itchy), VACCINATION SITE ERYTHEMA (red area 4or 5 inches below the injection site) and VACCINATION SITE PAIN (at the beginning hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 immunisation.     The patient's past medical history included Migraine headache (Migraine Headache Syndrome). Concomitant products included LOSARTAN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced EYE DISORDER (disorder visual field, with some spots and with some white flashes in the field). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (kind of warm to the touch), VACCINATION SITE PRURITUS (then it was itchy), VACCINATION SITE ERYTHEMA (red area 4or 5 inches below the injection site) and VACCINATION SITE PAIN (at the beginning hurt). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, EYE DISORDER (disorder visual field, with some spots and with some white flashes in the field), VACCINATION SITE WARMTH (kind of warm to the touch), VACCINATION SITE PRURITUS (then it was itchy), VACCINATION SITE ERYTHEMA (red area 4or 5 inches below the injection site) and VACCINATION SITE PAIN (at the beginning hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Cortisol cream on 30-Jan-2021. Concomitant medications include losartan.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Non-significant follow up appended.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the left arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in the left arm). On 18-Jan-2021, PAIN IN EXTREMITY (soreness in the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received on 16-Apr-2021 contains non-significant information of reporter email address.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin swelling
Clinical narrative: Skin around her eyes is tingling; Skin around her eyes is swelling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Skin around her eyes is tingling) and SKIN SWELLING (Skin around her eyes is swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Panic attacks.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PARAESTHESIA (Skin around her eyes is tingling) and SKIN SWELLING (Skin around her eyes is swelling). At the time of the report, PARAESTHESIA (Skin around her eyes is tingling) and SKIN SWELLING (Skin around her eyes is swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Aches all over her body; Low grade Fever; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches all over her body), PYREXIA (Low grade Fever) and HEADACHE (Mild Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN (Aches all over her body), PYREXIA (Low grade Fever) and HEADACHE (Mild Headache). At the time of the report, PAIN (Aches all over her body), PYREXIA (Low grade Fever) and HEADACHE (Mild Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; Case reference number MOD-2021-020252 is a spontaneous case report sent by a Non-Health Professional on 22-FEB-2021 00:00:00. .  On 1feb2021,  the patient was administered the second dose of  Moderna COVID-19 Vaccine for COVID-19 vaccination. The patient developed Headache.   The patient was treated with Excederin1500 daily.   The eventual diagnosis made on was Headache.  Follow-up required.   The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship.   Terse Narrative (narratives and signal review) Brief 3 line summary of above for listing: Report Source- Non-Health Professional,  Age-  ,  Sex-  ,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- Headaches - Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: left lower back pain; very tired; arm started to be painful and stiff; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (arm started to be painful and stiff), FATIGUE (very tired) and BACK PAIN (left lower back pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for an unknown indication.     The patient's past medical history included UTI.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm started to be painful and stiff). On 26-Jan-2021, the patient experienced FATIGUE (very tired). On 27-Jan-2021, the patient experienced BACK PAIN (left lower back pain). On 29-Jan-2021, PAIN IN EXTREMITY (arm started to be painful and stiff), FATIGUE (very tired) and BACK PAIN (left lower back pain) had resolved.
Sex: M
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: hot flushed face; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushed face) 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 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jan-2021, the patient experienced HOT FLUSH (hot flushed face).            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling at the injection site; redness at the injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (itching at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20) for COVID-19 vaccination.     Concurrent medical conditions included Vaccination site swelling on 23-Jan-2021, Vaccination site erythema on 23-Jan-2021 and Vaccination site swelling on 23-Jan-2021.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (itching at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (itching at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-020032 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Fatigue; weak; A spontaneous report was received from an other healthcare concerning a 75 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue and weak/asthenia.  The patient's medical history included multiple sclerosis and chemotherapy. Products known to have been used by the patient, within two weeks prior to the event, included Rituximab infusion.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) on 13 Feb 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.   The patient reports that he has been very fatigued and weak. Treatment for the event included Paracetamol.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events fatigue and weak was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: woke up sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (woke up sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (woke up sweating). At the time of the report, HYPERHIDROSIS (woke up sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Fatigue, Hypertension
Clinical narrative: Two days later blood pressure was 130/90 (close to 110); He is aware that he may have Hypertension; Was aware that one of the side effects could be tiredness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE ABNORMAL (Two days later blood pressure was 130/90 (close to 110)), HYPERTENSION (He is aware that he may have Hypertension) and FATIGUE (Was aware that one of the side effects could be tiredness) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Jan-2021, the patient experienced BLOOD PRESSURE ABNORMAL (Two days later blood pressure was 130/90 (close to 110)), HYPERTENSION (He is aware that he may have Hypertension) and FATIGUE (Was aware that one of the side effects could be tiredness). At the time of the report, BLOOD PRESSURE ABNORMAL (Two days later blood pressure was 130/90 (close to 110)), HYPERTENSION (He is aware that he may have Hypertension) and FATIGUE (Was aware that one of the side effects could be tiredness) 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.   No treatment information was provided.  Patient reports Two after receiving his blood pressure was 130/90 (close to 110), blood pressure dropped again to 110/63. Did not take any medication, ate some crackers and drank class of coke for the salt. Blood pressure came back up to 128/80 and he was very tired. He is aware that he may have Hypertension but has never been clinically diagnosed with it.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Arm started to itch at the injection site; Injection site red; Injection site swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (Arm started to itch at the injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site swollen) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Arm started to itch at the injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site swollen). At the time of the report, INJECTION SITE PRURITUS (Arm started to itch at the injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. The patient reported the redness is like a rash that started as a patch of red and moves every day. It has moved one inch to the elbow and towards underneath her arm. She went to her doctor, who instructed her to contact Moderna.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: large red spot 3 to 4 diameter; Extremally itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (large red spot 3 to 4 diameter) and PRURITUS (Extremally itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included No adverse event (No Reported Medical event).    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced RASH MACULAR (large red spot 3 to 4 diameter) and PRURITUS (Extremally itchy). At the time of the report, RASH MACULAR (large red spot 3 to 4 diameter) and PRURITUS (Extremally itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling of body temperature change, Pyrexia
Clinical narrative: Hot and cold; Weakness; Fever; A spontaneous report was received from a consumer concerning herself a 93-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed fever/pyrexia, weakness/ asthenia, and she was also cold and hot/ feeling of body temperature change.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Jan 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date, the patient developed fever, weakness, and she was also cold and hot. She was sick for about 4 weeks Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   The outcome of events, fever, weakness, and she was also cold and hot were unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Illness, Nasopharyngitis, Pyrexia
Clinical narrative: ever since she is sick; cold; Chills; burning in skin; fever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ever since she is sick), NASOPHARYNGITIS (cold), CHILLS (Chills), SKIN BURNING SENSATION (burning in skin) and PYREXIA (fever) in a 71-year-old female patient 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (ever since she is sick), NASOPHARYNGITIS (cold), CHILLS (Chills), SKIN BURNING SENSATION (burning in skin), PYREXIA (fever) and DECREASED APPETITE (no appetite).            Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: ever since she is sick; cold; Chills; burning in skin; fever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ever since she is sick), NASOPHARYNGITIS (cold), CHILLS (Chills), SKIN BURNING SENSATION (burning in skin) and PYREXIA (fever) in a 71-year-old female patient 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (ever since she is sick), NASOPHARYNGITIS (cold), CHILLS (Chills), SKIN BURNING SENSATION (burning in skin), PYREXIA (fever) and DECREASED APPETITE (no appetite).            Reporter did not allow further contact
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: A Spontanous  report (UNITED STATES) was received concerning a 87 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 9-feb-2021 and experienced events     The patient's medical history was unknown     On 09 MAR 2021 she got her first dose of mRNA-1273 vaccine  intramuscularly and batch no:030M20A,   SHE Received the first dose of the Moderna vaccine on 9feb2021, next day big, hard, hot, lump on her  arm-lasted one day. Was also itching. On the 16th or 17th of Feb2021 has had hives itching like mad.  SHE Was put on a steroid yesterday 21FEB2021 helped a lot.  Consent for safety to follow up.  Treatment information was unknown.concaminant drug also not provided  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were Unknown
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: A Spontanous  report (UNITED STATES) was received concerning a 87 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) on 9-feb-2021 and experienced events     The patient's medical history was unknown     On 09 MAR 2021 she got her first dose of mRNA-1273 vaccine  intramuscularly and batch no:030M20A,   SHE Received the first dose of the Moderna vaccine on 9feb2021, next day big, hard, hot, lump on her  arm-lasted one day. Was also itching. On the 16th or 17th of Feb2021 has had hives itching like mad.  SHE Was put on a steroid yesterday 21FEB2021 helped a lot.  Consent for safety to follow up.  Treatment information was unknown.concaminant drug also not provided  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were Unknown
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness around injection site; Itchiness/ Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness/ Itchiness) and INJECTION SITE ERYTHEMA (redness around injection site) in an unknown age, female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    Previously administered products included for an unreported indication: .   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (unknown route) at an unspecified dose. On 16-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness/ Itchiness). On 25-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness around injection site). On 17-Jan-2021, INJECTION SITE PRURITUS (Itchiness/ Itchiness) outcome was unknown. At the time of the report, INJECTION SITE ERYTHEMA (redness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Upon in internal review on 21 May 2021, the age was corrected to unknown age.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site abscess, Vaccination site erythema
Clinical narrative: site problem; large area of redness that has grown; started about 7 or 8 days after the vaccine was given; continued to grow from about 2 inches in diameter to 4; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ABSCESS (site problem), VACCINATION SITE ERYTHEMA (large area of redness that has grown), VACCINATION SITE ERYTHEMA (started about 7 or 8 days after the vaccine was given) and VACCINATION SITE ERYTHEMA (continued to grow from about 2 inches in diameter to 4) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE ABSCESS (site problem), VACCINATION SITE ERYTHEMA (large area of redness that has grown), VACCINATION SITE ERYTHEMA (started about 7 or 8 days after the vaccine was given) and VACCINATION SITE ERYTHEMA (continued to grow from about 2 inches in diameter to 4). At the time of the report, VACCINATION SITE ABSCESS (site problem), VACCINATION SITE ERYTHEMA (large area of redness that has grown), VACCINATION SITE ERYTHEMA (started about 7 or 8 days after the vaccine was given) and VACCINATION SITE ERYTHEMA (continued to grow from about 2 inches in diameter to 4) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Antibiotics were taken as treatment drugs
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash papular
Clinical narrative: redness; 2 inch x 5 inch raised up to 1cm in the center; Irregular Itching; Soreness in arm; A spontaneous report was received from a Health care professional concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Soreness in arm, 2 inch x 5 inch raised up to 1cm in the center,  and Redness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 via Intramuscular route for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the event Soreness in arm. On 24 Jan 2021, the patient experienced the event 2 inch x 5 inch raised up to 1cm in the center, and Redness. The Patient was treated with Benadryl (25 mg).  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events Soreness in arm, 2 inch x 5 inch raised up to 1cm in the center and Redness was Not Recovered/Not Resolved.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache). On 29-Jan-2021, HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  No concomitant drugs and treatment drugs are provided     Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Periorbital swelling, Skin swelling
Clinical narrative: below my left eye became red; my left cheek became very puffy; below my left eye became very puffy; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (below my left eye became red), SKIN SWELLING (my left cheek became very puffy) and PERIORBITAL SWELLING (below my left eye became very puffy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced ERYTHEMA (below my left eye became red), SKIN SWELLING (my left cheek became very puffy) and PERIORBITAL SWELLING (below my left eye became very puffy). At the time of the report, ERYTHEMA (below my left eye became red), SKIN SWELLING (my left cheek became very puffy) and PERIORBITAL SWELLING (below my left eye became very puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore and achy arm after injection; 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 sore and achy arm after injection (Arthralgia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  Prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, case received by safety. Patient experienced the event(s) sore and achy arm after injection (Arthralgia).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore and achy arm after injection (Arthralgia), was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Neck pain
Clinical narrative: headache; painful arm; felt lightheaded; fatigue; neckache; fever 102.3ºF; was not hungry; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (painful arm), FATIGUE (fatigue), HEADACHE (headache), NECK PAIN (neckache) and PYREXIA (fever 102.3ºF) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid, LIRAGLUTIDE (VICTOZA) for Weight loss, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (ATORVASTATINE ACCORD) and TRAZODONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue), NECK PAIN (neckache), PYREXIA (fever 102.3ºF) and DECREASED APPETITE (was not hungry). On 27-Jan-2021, the patient experienced DIZZINESS (felt lightheaded). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) and HEADACHE (headache). On 24-Jan-2021, FATIGUE (fatigue), NECK PAIN (neckache), PYREXIA (fever 102.3ºF) and DECREASED APPETITE (was not hungry) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), HEADACHE (headache) and DIZZINESS (felt lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: headache; painful arm; felt lightheaded; fatigue; neckache; fever 102.3ºF; was not hungry; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (painful arm), FATIGUE (fatigue), HEADACHE (headache), NECK PAIN (neckache) and PYREXIA (fever 102.3ºF) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid, LIRAGLUTIDE (VICTOZA) for Weight loss, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (ATORVASTATINE ACCORD) and TRAZODONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue), NECK PAIN (neckache), PYREXIA (fever 102.3ºF) and DECREASED APPETITE (was not hungry). On 27-Jan-2021, the patient experienced DIZZINESS (felt lightheaded). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) and HEADACHE (headache). On 24-Jan-2021, FATIGUE (fatigue), NECK PAIN (neckache), PYREXIA (fever 102.3ºF) and DECREASED APPETITE (was not hungry) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), HEADACHE (headache) and DIZZINESS (felt lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: itching; redness; wrist pain that radiates to forearm; hot; pain at injection site; A spontaneous report was received from a nurse concerning a 75-year-old, female patient, who received  Moderna's  COVID-19 vaccine (mRNA-1273) and experienced Redness expanding,  warmth, pain at injection site, wrist  pain that radiates from forearm, itching. The patient's medical history, was not provided by the reporter.  On 20 Jan 2021 , the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the  arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021 the patient experienced the event pain at injection site and it got resolved on 22 Jan 2021. Again on 26 Jan 2021 she reported redness expanding, warmth, wrist pain that radiates  to fore arm, itching.  Treatment  information was not provided. Action taken with mRNA-1273 in response to the events was not reported.   The events,  pain at injection site got resolved on 22 Jan 2021. Redness expanding, warmth, wrist pain that radiates to fore arm, itching were considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at the injection site; Swelling at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Rash on the abdomen; Headache; Sore neck; extreme tiredness; fever; Sore arm; A SPONTANEOUS REPORT from was received concerning a 75 Years old, Female patient who received Moderna's COVID-19 shot  on 11FEB and only had a slight, sore arm. No medication needed. On the 19th she had what seems to be a reaction with headache, sore neck, extreme tiredness and a fever of 100F.  She called back again on 22feb2021  she I woke up feeling fine and her fever was in 98F. But then last night she developed a rash on my abdomen. Ishe already completed that V-safe form. Agent confirmed the patient did not consume or apply any treatment medication, and collected thyroid medication and Lipitor as concomitant drugs. When the agent asked for a primary doctor's contact, the caller mentioned she has recently transferred into a new state and didn't have a new primary doctor yet  Treatment outcome is unknown
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on the abdomen; Headache; Sore neck; extreme tiredness; fever; Sore arm; A SPONTANEOUS REPORT from was received concerning a 75 Years old, Female patient who received Moderna's COVID-19 shot  on 11FEB and only had a slight, sore arm. No medication needed. On the 19th she had what seems to be a reaction with headache, sore neck, extreme tiredness and a fever of 100F.  She called back again on 22feb2021  she I woke up feeling fine and her fever was in 98F. But then last night she developed a rash on my abdomen. Ishe already completed that V-safe form. Agent confirmed the patient did not consume or apply any treatment medication, and collected thyroid medication and Lipitor as concomitant drugs. When the agent asked for a primary doctor's contact, the caller mentioned she has recently transferred into a new state and didn't have a new primary doctor yet  Treatment outcome is unknown