chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stabbing pain; Fever; Chills; Headache; muscle aches , back in knots; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots).   At the time of the report, PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain in extremity
Clinical narrative: had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint; He also had a headache, that was sharp and it came and subsided, came and subsided; sore arm; had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint), HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP), METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint), HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint). On 21-Jan-2021, MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) had resolved. On 22-Jan-2021, HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications:two medications for anxiety, hydrocholon and albuterol sulphate inhaler.  reatment medication were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient reported about Dose-1 event outcome. Patient said he recovered from the events and there were no events after second dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Glossodynia, Headache, Lip swelling
Clinical narrative: Chills; fatigue, could hardly stand; Sore tongue; headache; lips swollen due to the soreness; muscles spasms; Sore mouth; low fever 100.1 F; A spontaneous report was received from a type concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fatigue, glossodynia (sore tongue), headache, lip swelling (lips swollen due to the soreness), muscle spasms, oral pain (sore mouth) and pyrexia (low fever 100.1 F).  The patient's medical history was not provided. Concomitant medications reported were alpha lipoic acid, atorvastatin 40mg, calcium, flowfe iron supplements,  letrozole 2,5mg, losartan 30mg, melatonin, omeprazole 40mg, sertraline 150mg,  vitamin A, vitamin B, vitamin C, vitamin D3, zinc for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, muscles spasms, low fever 100.1 F, fatigue, could hardly stand, chills, sore mouth, sore tongue and  lips swollen due to the soreness.  Treatment details included : Tylenol every 5 hours since 4 in the morning on the 20 Feb 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, fatigue and fever are consistent with the known safety profile of mRNA-1273
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oral pain, Pyrexia
Clinical narrative: Chills; fatigue, could hardly stand; Sore tongue; headache; lips swollen due to the soreness; muscles spasms; Sore mouth; low fever 100.1 F; A spontaneous report was received from a type concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fatigue, glossodynia (sore tongue), headache, lip swelling (lips swollen due to the soreness), muscle spasms, oral pain (sore mouth) and pyrexia (low fever 100.1 F).  The patient's medical history was not provided. Concomitant medications reported were alpha lipoic acid, atorvastatin 40mg, calcium, flowfe iron supplements,  letrozole 2,5mg, losartan 30mg, melatonin, omeprazole 40mg, sertraline 150mg,  vitamin A, vitamin B, vitamin C, vitamin D3, zinc for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, muscles spasms, low fever 100.1 F, fatigue, could hardly stand, chills, sore mouth, sore tongue and  lips swollen due to the soreness.  Treatment details included : Tylenol every 5 hours since 4 in the morning on the 20 Feb 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, fatigue and fever are consistent with the known safety profile of mRNA-1273
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Altered visual depth perception, Blood pressure increased, Erythema, Feeling hot, Hypersensitivity
Clinical narrative: red marks all over face and hands; felt hot; couldn't sleep; allergy reactions; lost depth perception; psychedelic pattern in vision; insignificant arm pain; Blood pressure increased; Rash on forehead; hives; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions) and ALTERED VISUAL DEPTH PERCEPTION (lost depth perception) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHENAMINE HIPPURATE (HIPREX [METHENAMINE HIPPURATE]) for Bladder infection, NORTRIPTYLINE for Facial pain, ATORVASTATIN, MULTIVITAMIN [VITAMINS NOS] and DENOSUMAB (PROLIA) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased), RASH (Rash on forehead) and URTICARIA (hives). On an unknown date, the patient experienced ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions), ALTERED VISUAL DEPTH PERCEPTION (lost depth perception), VISUAL IMPAIRMENT (psychedelic pattern in vision) and MYALGIA (insignificant arm pain). On 15-Feb-2021, URTICARIA (hives) had resolved. At the time of the report, ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions), ALTERED VISUAL DEPTH PERCEPTION (lost depth perception), VISUAL IMPAIRMENT (psychedelic pattern in vision), BLOOD PRESSURE INCREASED (Blood pressure increased), RASH (Rash on forehead) and MYALGIA (insignificant arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: 180/135 (High) 180/135 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication used was Benadryl   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded. On 28-Apr-2021: NNI, additional info 2 On 28-Apr-2021: Additional info 3 On 29-Apr-2021: No specific follow-up information recorded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Rash, Urticaria, Visual impairment
Clinical narrative: red marks all over face and hands; felt hot; couldn't sleep; allergy reactions; lost depth perception; psychedelic pattern in vision; insignificant arm pain; Blood pressure increased; Rash on forehead; hives; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions) and ALTERED VISUAL DEPTH PERCEPTION (lost depth perception) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHENAMINE HIPPURATE (HIPREX [METHENAMINE HIPPURATE]) for Bladder infection, NORTRIPTYLINE for Facial pain, ATORVASTATIN, MULTIVITAMIN [VITAMINS NOS] and DENOSUMAB (PROLIA) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased), RASH (Rash on forehead) and URTICARIA (hives). On an unknown date, the patient experienced ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions), ALTERED VISUAL DEPTH PERCEPTION (lost depth perception), VISUAL IMPAIRMENT (psychedelic pattern in vision) and MYALGIA (insignificant arm pain). On 15-Feb-2021, URTICARIA (hives) had resolved. At the time of the report, ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions), ALTERED VISUAL DEPTH PERCEPTION (lost depth perception), VISUAL IMPAIRMENT (psychedelic pattern in vision), BLOOD PRESSURE INCREASED (Blood pressure increased), RASH (Rash on forehead) and MYALGIA (insignificant arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: 180/135 (High) 180/135 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication used was Benadryl   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded. On 28-Apr-2021: NNI, additional info 2 On 28-Apr-2021: Additional info 3 On 29-Apr-2021: No specific follow-up information recorded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Sleep disorder, Vomiting
Clinical narrative: fatigue many days; sleep disturbance; light vomit; This case was received via an unknown source (no reference has been entered for a Regulatory Authority) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (light vomit), FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced VOMITING (light vomit). On an unknown date, the patient experienced FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance). At the time of the report, VOMITING (light vomit), FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: Body aches; very sick; sweating; loss of appetite; vomiting; headache; high fever at 103.2F; light chills/ Severe Chill; soreness but nothing much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite) and VOMITING (vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (soreness but nothing much) and CHILLS (light chills/ Severe Chill). On 28-Jan-2021, the patient experienced ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache) and PYREXIA (high fever at 103.2F). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache), PYREXIA (high fever at 103.2F) and CHILLS (light chills/ Severe Chill) had not resolved and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2F.         No concomitant drug reported. Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-mar-2021 contains second dose information, new event updated. On 29-Apr-2021: Follow up received on 29-apr-2021 contains no new information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain, Pyrexia, Vomiting
Clinical narrative: Body aches; very sick; sweating; loss of appetite; vomiting; headache; high fever at 103.2F; light chills/ Severe Chill; soreness but nothing much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite) and VOMITING (vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (soreness but nothing much) and CHILLS (light chills/ Severe Chill). On 28-Jan-2021, the patient experienced ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache) and PYREXIA (high fever at 103.2F). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache), PYREXIA (high fever at 103.2F) and CHILLS (light chills/ Severe Chill) had not resolved and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2F.         No concomitant drug reported. Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-mar-2021 contains second dose information, new event updated. On 29-Apr-2021: Follow up received on 29-apr-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Swelling face, Vaccination site pain
Clinical narrative: swelling in her eye; swelling in her face/ swelling in her cheek; chills; injection site pain - left arm; A spontaneous report was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, vaccination site pain ( injection site pain - left arm), eye swelling (swelling in her eye) and swelling face (swelling in her cheek).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced chills and injection site pain. On 22 Feb 2021, the patient experienced swelling in her face, swelling in her eye and swelling in her cheek. she also stated that on 23 Feb 2021, the swelling of the face had worsened.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills and Injection site pain are consistent with the known safety profile of mRNA-1273.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus, Rash
Clinical narrative: area of injection is also itchy but is not as bad as her back; experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness; rash on her right shoulder blade area of her back.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.) in a 62-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.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.). At the time of the report, INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Tigerbalm and Benadryl; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash and injection site pruritus are consistent with the known safety profile of mRNA-1273
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Listless
Clinical narrative: ight-headed; listless; tired; headache; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), HEADACHE (headache), INJECTION SITE PAIN (injection site soreness), DIZZINESS (ight-headed) and LISTLESS (listless) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Pneumonia. Concomitant products included LISINOPRIL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (tired), HEADACHE (headache), INJECTION SITE PAIN (injection site soreness) and LISTLESS (listless). On 23-Feb-2021, the patient experienced DIZZINESS (ight-headed). On 19-Feb-2021, INJECTION SITE PAIN (injection site soreness) had resolved. On 20-Feb-2021, FATIGUE (tired), HEADACHE (headache) and LISTLESS (listless) had resolved. At the time of the report, DIZZINESS (ight-headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Tylenol; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, injection site pain and fatigue are consistent with the known safety profile of mRNA-1273
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Ache base of skull; Feeling listless, tired immediately after receiving the vaccine; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), PAIN (Ache base of skull) and FATIGUE (Feeling listless, tired immediately after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Feeling listless, tired immediately after receiving the vaccine). On an unknown date, the patient experienced PAIN (Ache base of skull). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), PAIN (Ache base of skull) and FATIGUE (Feeling listless, tired immediately after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the known safety profile of mRNA-1273; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the known safety profile of mRNA-1273
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity, Skin exfoliation
Clinical narrative: Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), PAIN IN EXTREMITY (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), INJECTION SITE PRURITUS (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) and INJECTION SITE SWELLING (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) 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 SKIN EXFOLIATION (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), PAIN IN EXTREMITY (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), INJECTION SITE PRURITUS (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) and INJECTION SITE SWELLING (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better). At the time of the report, SKIN EXFOLIATION (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), PAIN IN EXTREMITY (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), INJECTION SITE PRURITUS (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) and INJECTION SITE SWELLING (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site swelling is consistent with the known safety profile of mRNA-1273
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall
Clinical narrative: Fell in the kitchen; Bruise on her arm; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell in the kitchen) and CONTUSION (Bruise on her arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FALL (Fell in the kitchen) and CONTUSION (Bruise on her arm). At the time of the report, FALL (Fell in the kitchen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: There is not enough information to assess the relationship between the event of fall and the administration of mRNA-1273.  Critical details such as the patient's medical history and latency from onset of the event to vaccine administration is lacking.  the bruise resulted from the fall and is assessed as unlikely related to product use.  All events are confounded by the patient's advanced age.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: pain at injection; muscle swelling; hot; itching; red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red).   At the time of the report, INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Fever blister; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Fever blister). At the time of the report, ORAL HERPES (Fever blister) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient had acyclovir she usually took for the blisters but had not taken any yet.  The patient had gotten fever blisters since the patient was a child and this was not out of the ordinary. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated second dose had taken and event history. On 12-Jul-2021: Follow up received and contains No New Information.
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Gingival pain, Headache, Tooth infection
Clinical narrative: Little sore in the face; Soreness in the gums; Tooth infection; Strange headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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 an unknown date, the patient experienced FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache). At the time of the report, FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the information provide, the causal association between the reported events and the administration of the mRNA-1273 vaccine is assessed as unlikely.  Event is assessed as due to the underlying infection although headache is consistent with the known profile of the vaccines.  Tooth infection causing pain has also been found to cause headaches.; Sender's Comments: Based on the information provide, the causal association between the reported events and the administration of the mRNA-1273 vaccine is assessed as unlikely.  Event is assessed as due to the underlying infection although headache is consistent with the known profile of the vaccines.  Tooth infection causing pain has also been found to cause headaches.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe head ache in the side of his head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe head ache in the side of his head) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (Severe head ache in the side of his head). At the time of the report, HEADACHE (Severe head ache in the side of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included Acetaminophen; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the known safety profile of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: swollen gland; very sore throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat) 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 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat). At the time of the report, LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Splenomegaly
Clinical narrative: Enlarged spleen; Burning in her chest; Severe stomach pains; A spontaneous report was received from a consumer concerning for his wife, a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning in her chest/Chest pain, severe stomach pains/Abdominal pain upper, enlarged spleen/Splenomegaly.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29Jan2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events burning in her chest, severe stomach pains after her first shot, Physician said she has an enlarged spleen. Treatment information was not provided. The event severe stomach pains was considered as medically significant by reporter.   Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, burning in her chest, severe stomach pains, enlarged spleen was unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Hot; itch; hive; Swollen; red; soreness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive) and VACCINATION SITE SWELLING (Swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (soreness) and VACCINATION SITE PAIN (Sore arm). On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Hot; itch; hive; Swollen; red; soreness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive) and VACCINATION SITE SWELLING (Swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (soreness) and VACCINATION SITE PAIN (Sore arm). On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity
Clinical narrative: Left lower limb swelling; left leg pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Left lower limb swelling), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (Joint pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 11-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 OEDEMA PERIPHERAL (Left lower limb swelling), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL at an unspecified dose and frequency and CODEINE at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Left lower limb swelling), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: F/U received on 30-APR-2021,No New Information reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Initial insomnia, Vaccination site pain
Clinical narrative: Felt fatigue; Slight headache; Sore arm; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     The patient's past medical history included No adverse event.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep) outcome 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
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cold Compress. relevant concomitant products usage were not reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: F/U received on 28-APR-2021,No New Information reported.