chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Headache, Hyperventilation
Clinical narrative: panic attack; like she couldn't breathe; hyperventilating; feeling crappy; headache; sick to stomach; diarrhea; couldn't sleep; red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe) and HYPERVENTILATION (hyperventilating) in a 67-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.     The patient's past medical history included Spinal cord injury (Patient had spinal cord injury due  to tumor she had 24 years ago and she often got 400units of Botox injected into her spine to stop muscle spasm..) since an unknown date, Hip fracture (patient had Hip fracture about 15 years ago.) since an unknown date and Spinal cord operation (Patient had two surgery done on her spinal code and last one was done in 2014, hence she tends to have neurological pain all the time.) since an unknown date. Concurrent medical conditions included Neurological disorder NOS (Neurological pain.). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Muscle spasm, IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Spinal cord injury.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep) and URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs). On an unknown date, the patient experienced PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), HEADACHE (headache) and NAUSEA (sick to stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs), HEADACHE (headache) and NAUSEA (sick to stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient gets IVIG once a month.  Patient received botox  up and down paraspinous muscle from  neck to sacrum  by HCP .  Treatment includes Benadryl but patient had diarrhea in the night and couldn't sleep throughout the night.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Significant FollowUp appended New events are added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Panic attack, Urticaria
Clinical narrative: panic attack; like she couldn't breathe; hyperventilating; feeling crappy; headache; sick to stomach; diarrhea; couldn't sleep; red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe) and HYPERVENTILATION (hyperventilating) in a 67-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.     The patient's past medical history included Spinal cord injury (Patient had spinal cord injury due  to tumor she had 24 years ago and she often got 400units of Botox injected into her spine to stop muscle spasm..) since an unknown date, Hip fracture (patient had Hip fracture about 15 years ago.) since an unknown date and Spinal cord operation (Patient had two surgery done on her spinal code and last one was done in 2014, hence she tends to have neurological pain all the time.) since an unknown date. Concurrent medical conditions included Neurological disorder NOS (Neurological pain.). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Muscle spasm, IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Spinal cord injury.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep) and URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs). On an unknown date, the patient experienced PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), HEADACHE (headache) and NAUSEA (sick to stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), INSOMNIA (couldn't sleep), PANIC ATTACK (panic attack), DYSPNOEA (like she couldn't breathe), HYPERVENTILATION (hyperventilating), FEELING ABNORMAL (feeling crappy), URTICARIA (red, burning, itchy, swollen, welt running down her left and right leg and at the back of her legs), HEADACHE (headache) and NAUSEA (sick to stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient gets IVIG once a month.  Patient received botox  up and down paraspinous muscle from  neck to sacrum  by HCP .  Treatment includes Benadryl but patient had diarrhea in the night and couldn't sleep throughout the night.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Significant FollowUp appended New events are added.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphagia, Dyspnoea, Speech disorder
Clinical narrative: Difficulty when talking; Difficulty in breathing; Felt weak; Difficulty to swallow; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty to swallow), ASTHENIA (Felt weak), SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPHAGIA (Difficulty to swallow). On 05-Feb-2021, the patient experienced ASTHENIA (Felt weak). On an unknown date, the patient experienced SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing). At the time of the report, DYSPHAGIA (Difficulty to swallow), ASTHENIA (Felt weak), SPEECH DISORDER (Difficulty when talking) and DYSPNOEA (Difficulty in breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinner medicine.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear swelling, Erythema, Fatigue, Malaise
Clinical narrative: warm at location of shot; arm was red and warm and had the normal soreness and achiness; nausea; fatigue for 3-4 days; like I was going to pass out; light headed, dizzy; swelling in inner ear; unwell for 45 minutes to an hour; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour) and VACCINATION SITE WARMTH (warm at location of shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS (has History of allergies).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour), NAUSEA (nausea) and FATIGUE (fatigue for 3-4 days). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm at location of shot) and ERYTHEMA (arm was red and warm and had the normal soreness and achiness). The patient was treated with CETIRIZINE for Premedication and Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Premedication and Adverse reaction, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour), VACCINATION SITE WARMTH (warm at location of shot), ERYTHEMA (arm was red and warm and had the normal soreness and achiness), NAUSEA (nausea) and FATIGUE (fatigue for 3-4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Presyncope, Vaccination site warmth
Clinical narrative: warm at location of shot; arm was red and warm and had the normal soreness and achiness; nausea; fatigue for 3-4 days; like I was going to pass out; light headed, dizzy; swelling in inner ear; unwell for 45 minutes to an hour; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour) and VACCINATION SITE WARMTH (warm at location of shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS (has History of allergies).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour), NAUSEA (nausea) and FATIGUE (fatigue for 3-4 days). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm at location of shot) and ERYTHEMA (arm was red and warm and had the normal soreness and achiness). The patient was treated with CETIRIZINE for Premedication and Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Premedication and Adverse reaction, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (like I was going to pass out), DIZZINESS (light headed, dizzy), EAR SWELLING (swelling in inner ear), MALAISE (unwell for 45 minutes to an hour), VACCINATION SITE WARMTH (warm at location of shot), ERYTHEMA (arm was red and warm and had the normal soreness and achiness), NAUSEA (nausea) and FATIGUE (fatigue for 3-4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes on left side) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on left side). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Medications: back pain medicine. No treatment information was provided.   This case was linked to MOD-2021-034245 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Reporter's email address information added; Sender's Comments:  MOD-2021-034245:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-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 28-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-017817, US-MODERNATX, INC.-MOD-2021-010482, US-MODERNATX, INC.-MOD-2021-017800, US-MODERNATX, INC.-MOD-2021-017750, US-MODERNATX, INC.-MOD-2021-010477, US-MODERNATX, INC.-MOD-2021-017674, US-MODERNATX, INC.-MOD-2021-019767, US-MODERNATX, INC.-MOD-2021-019740, US-MODERNATX, INC.-MOD-2021-019718, US-MODERNATX, INC.-MOD-2021-017795, US-MODERNATX, INC.-MOD-2021-028790, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-017817:Crosslinked (MOD21-018034) US-MODERNATX, INC.-MOD-2021-010482:Crosslinked (MOD21-018048) US-MODERNATX, INC.-MOD-2021-017800:Crosslinked (MOD21-018071) US-MODERNATX, INC.-MOD-2021-017750:Crosslinked (MOD21-018080) US-MODERNATX, INC.-MOD-2021-010477:Crosslinked (MOD21-018089) US-MODERNATX, INC.-MOD-2021-017674:Crosslinked (MOD21-018092) US-MODERNATX, INC.-MOD-2021-019767:Crosslinked (MOD21-018097) US-MODERNATX, INC.-MOD-2021-019740:Crosslinked (MOD21-018102) US-MODERNATX, INC.-MOD-2021-019718:Crosslinked (MOD21-018111) US-MODERNATX, INC.-MOD-2021-017795:Crosslinked (MOD21-018119) US-MODERNATX, INC.-MOD-2021-028790:Crosslinked (MOD21-018124) US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018126)
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site rash, Vaccination site warmth
Clinical narrative: Little warmer at injection site; Solid at injection site; red rash the size of a silver dollar and solid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20) for COVID-19 vaccination.     Concomitant products included Blood pressure meds for Blood pressure management, Thyroid meds for Thyroid disorder, PANTOPRAZOLE SODIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid). At the time of the report, VACCINATION SITE WARMTH (Little warmer at injection site), VACCINATION SITE INDURATION (Solid at injection site) and VACCINATION SITE RASH (red rash the size of a silver dollar and solid) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: follow up received on 20-JUN-2021 and contains no new information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Oral herpes, Pain
Clinical narrative: Outbreak of cold sore on lips; Body aches; Nausea; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Outbreak of cold sore on lips), PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue). On 04-Feb-2021, the patient experienced ORAL HERPES (Outbreak of cold sore on lips). The patient was treated with ACETAMINOPHEN for Adverse event following immunisation, at an unspecified dose and frequency and DOCOSANOL (ABREVA) for Cold sores lip, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Outbreak of cold sore on lips), PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram, Confusional state, Headache, Incoherent
Clinical narrative: General Confusion; Aphasia; Difficulty Talking Coherently, difficult time remembering wife and son's names; Intermittent Sharp Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Lumbar myelography (patient had a somewhat similar response several years ack to a lumbar myelogram. The fluid that is introduced called isovue which has iodine possibly aused the response.).    On 29-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 CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches). On 31-Jan-2021, CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Computerised tomogram: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage. On 30-Jan-2021, Magnetic resonance imaging: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage.     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 relevant concomitant medications were reported.   No treatment information was provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: General Confusion; Aphasia; Difficulty Talking Coherently, difficult time remembering wife and son's names; Intermittent Sharp Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Lumbar myelography (patient had a somewhat similar response several years ack to a lumbar myelogram. The fluid that is introduced called isovue which has iodine possibly aused the response.).    On 29-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 CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches). On 31-Jan-2021, CONFUSIONAL STATE (General Confusion), APHASIA (Aphasia), INCOHERENT (Difficulty Talking Coherently, difficult time remembering wife and son's names) and HEADACHE (Intermittent Sharp Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Computerised tomogram: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage. On 30-Jan-2021, Magnetic resonance imaging: (Inconclusive) Neither a CT Scan nor a MRI showed acute occurrence of bleed or blockage.     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 relevant concomitant medications were reported.   No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Lethargy
Clinical narrative: flu like symptoms; extreme lethargic; delayed reaction; headache; severe muscle ache; fatigue; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache) and MYALGIA (severe muscle ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills). The patient was treated with IBUPROFEN ongoing since an unknown date for Fatigue and Chills, at a dose of 200 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills) had resolved. Not Provided      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 products included Over the counter Prilosec: 20 milligram once a day.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Type IV hypersensitivity reaction
Clinical narrative: flu like symptoms; extreme lethargic; delayed reaction; headache; severe muscle ache; fatigue; sever chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache) and MYALGIA (severe muscle ache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills). The patient was treated with IBUPROFEN ongoing since an unknown date for Fatigue and Chills, at a dose of 200 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (extreme lethargic), TYPE IV HYPERSENSITIVITY REACTION (delayed reaction), HEADACHE (headache), MYALGIA (severe muscle ache), FATIGUE (fatigue) and CHILLS (sever chills) had resolved. Not Provided      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 products included Over the counter Prilosec: 20 milligram once a day.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was itchy; Injection site was red; Injection site was swollen; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itchy), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  The action taken with the drug was Not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with FAMCICLOVIR (FAMVIR [FAMCICLOVIR]) on 29-Jan-2021 for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Joint pain; Red arm; Swollen arm; Fever; Chills; Headache; Swollen lymph nodes at the arm of the injection; Fatigue; Vaccination site pain; This spontaneous case was reported by a health care professional and describes the occurrence of ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE SWELLING (Swollen arm), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0416Z0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient medication history was not provided by the reporter.  Concurrent medical conditions included Drug allergy (Aspirin, Toradol, Maclodent, Anaprox, Cotrast, nsids and Retromicin.) and Penicillin allergy. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Jan-2021, PYREXIA (Fever) had resolved. On 12-Jan-2021, CHILLS (Chills) had resolved. On 17-Jan-2021, ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE SWELLING (Swollen arm), HEADACHE (Headache), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. Not Provided      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.   This case was linked to MOD-2021-021517 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Joint pain; Red arm; Swollen arm; Fever; Chills; Headache; Swollen lymph nodes at the arm of the injection; Fatigue; Vaccination site pain; This spontaneous case was reported by a health care professional and describes the occurrence of ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE SWELLING (Swollen arm), PYREXIA (Fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0416Z0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient medication history was not provided by the reporter.  Concurrent medical conditions included Drug allergy (Aspirin, Toradol, Maclodent, Anaprox, Cotrast, nsids and Retromicin.) and Penicillin allergy. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE SWELLING (Swollen arm), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Jan-2021, PYREXIA (Fever) had resolved. On 12-Jan-2021, CHILLS (Chills) had resolved. On 17-Jan-2021, ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Red arm), VACCINATION SITE SWELLING (Swollen arm), HEADACHE (Headache), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. Not Provided      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.   This case was linked to MOD-2021-021517 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching around hairline, hair, some places on his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and PRURITUS (itching around hairline, hair, some places on his body) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Ischemic heart disease, Atrial fibrillation, General physical health deterioration (He has health issues) and Shellfish allergy.    On 01-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 URTICARIA (hives) and PRURITUS (itching around hairline, hair, some places on his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 04-Feb-2021 for Hives and Itching, at a dose of 25 milligram. On 04-Feb-2021, URTICARIA (hives) and PRURITUS (itching around hairline, hair, some places on his body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported he is a Vietnam veteran and was exposed to agent orange.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait inability, Groin pain, Illness
Clinical narrative: sickness; unable to walk/Couldn't walk and has had to crawl ever since; pain in her lower back; groin pain; Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness), GAIT INABILITY (unable to walk/Couldn't walk and has had to crawl ever since), BACK PAIN (pain in her lower back), GROIN PAIN (groin pain) and ARTHRALGIA (Hip pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT INABILITY (unable to walk/Couldn't walk and has had to crawl ever since), BACK PAIN (pain in her lower back), GROIN PAIN (groin pain) and ARTHRALGIA (Hip pain). On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness), GAIT INABILITY (unable to walk/Couldn't walk and has had to crawl ever since), BACK PAIN (pain in her lower back), GROIN PAIN (groin pain) and ARTHRALGIA (Hip pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment : Patient is taking pain pills and got a shot in her hip.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Events added and dosage text added On 20-Apr-2021: No specific follow-up information recorded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore, lasted about day and half; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore, lasted about day and half) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore, lasted about day and half). The patient was treated with NAPROXEN for Pain in arm, at a dose of 2 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm sore, lasted about day and half) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hypertension, Pain in extremity, Pyrexia
Clinical narrative: His blood pressure is a little high than normal for him; 99.9F temperature and now has a 101.3F temperature; Two bouts of extreme chills that last up to 20 minutes at a 30 minute interval between; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (His blood pressure is a little high than normal for him), PAIN IN EXTREMITY (Sore arm), PYREXIA (99.9F temperature and now has a 101.3F temperature) and CHILLS (Two bouts of extreme chills that last up to 20 minutes at a 30 minute interval between) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 04-Feb-2021, the patient experienced HYPERTENSION (His blood pressure is a little high than normal for him), PYREXIA (99.9F temperature and now has a 101.3F temperature) and CHILLS (Two bouts of extreme chills that last up to 20 minutes at a 30 minute interval between). At the time of the report, HYPERTENSION (His blood pressure is a little high than normal for him), PAIN IN EXTREMITY (Sore arm), PYREXIA (99.9F temperature and now has a 101.3F temperature) and CHILLS (Two bouts of extreme chills that last up to 20 minutes at a 30 minute interval between) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99.9 (High) 99.9F temperature and 101.3 (High) 101.3F temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant product included medicines for high blood pressure. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Patient felt like they had a flu; Arm pain; Muscle pain; Joint pain; Headache; Lowgrade fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Blood pressure (NOS).    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Lowgrade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Rheumatoid arthritis and Blood pressure medicine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient felt like they had a flu; Arm pain; Muscle pain; Joint pain; Headache; Lowgrade fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Blood pressure (NOS).    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Lowgrade fever). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Patient felt like they had a flu), VACCINATION SITE PAIN (Arm pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Lowgrade fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Rheumatoid arthritis and Blood pressure medicine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: chills so bad I can't stand it; fatigue; Headache; Joint pain; Nausea; Vomiting; I was not good; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), VOMITING (Vomiting) and MALAISE (I was not good). At the time of the report, CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), VOMITING (Vomiting) and MALAISE (I was not good) 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 relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: chills so bad I can't stand it; fatigue; Headache; Joint pain; Nausea; Vomiting; I was not good; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), VOMITING (Vomiting) and MALAISE (I was not good). At the time of the report, CHILLS (chills so bad I can't stand it), FATIGUE (fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea), VOMITING (Vomiting) and MALAISE (I was not good) 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 relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up appended
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included MONTELUKAST and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore right arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The other relevant concomitant medication was reported as injection for osteoporosis, twice a year.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (6 days later I contracted COVID) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced COVID-19 (6 days later I contracted COVID). At the time of the report, COVID-19 (6 days later I contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.