chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Tinnitus, Vertigo
Clinical narrative: Early morning had significant vertigo; Headache all day; Have had tinnitus ever since; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Early morning had significant vertigo), TINNITUS (Have had tinnitus ever since) and HEADACHE (Headache all day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced VERTIGO (Early morning had significant vertigo) and HEADACHE (Headache all day). In November 2021, the patient experienced TINNITUS (Have had tinnitus ever since). At the time of the report, VERTIGO (Early morning had significant vertigo), TINNITUS (Have had tinnitus ever since) and HEADACHE (Headache all day) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia
Clinical narrative: can't sleep; Rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (can't sleep) and HEART RATE INCREASED (Rapid heartbeat) 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 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INSOMNIA (can't sleep) and HEART RATE INCREASED (Rapid heartbeat). At the time of the report, INSOMNIA (can't sleep) and HEART RATE INCREASED (Rapid heartbeat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate increased: increased (High) rapid heartbeat.         No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Nasal congestion
Clinical narrative: she is  still sick; nose still stuff; nose starting running and started sneezing; chills; fever; fatigue,tired; headache; throat started hurting /  sore throat; arm sore,; and the one that aren't supper common, like  running nose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she is  still sick), NASAL CONGESTION (nose still stuff), OROPHARYNGEAL PAIN (throat started hurting /  sore throat), PAIN IN EXTREMITY (arm sore,) and RHINORRHOEA (and the one that aren't supper common, like  running nose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (throat started hurting /  sore throat), PAIN IN EXTREMITY (arm sore,), RHINORRHOEA (and the one that aren't supper common, like  running nose), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue,tired) and HEADACHE (headache). On 25-Nov-2021, the patient experienced ILLNESS (she is  still sick), NASAL CONGESTION (nose still stuff) and SNEEZING (nose starting running and started sneezing). In 2021, NASAL CONGESTION (nose still stuff) and OROPHARYNGEAL PAIN (throat started hurting /  sore throat) outcome was unknown, SNEEZING (nose starting running and started sneezing) had resolved. On 25-Nov-2021, PAIN IN EXTREMITY (arm sore,), RHINORRHOEA (and the one that aren't supper common, like  running nose), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue,tired) and HEADACHE (headache) had resolved. At the time of the report, ILLNESS (she is  still sick) had not resolved.            Treatment details was not reported by the reporter.   This case was linked to MOD-2021-397570, MOD-2021-397552 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: she is  still sick; nose still stuff; nose starting running and started sneezing; chills; fever; fatigue,tired; headache; throat started hurting /  sore throat; arm sore,; and the one that aren't supper common, like  running nose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she is  still sick), NASAL CONGESTION (nose still stuff), OROPHARYNGEAL PAIN (throat started hurting /  sore throat), PAIN IN EXTREMITY (arm sore,) and RHINORRHOEA (and the one that aren't supper common, like  running nose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (throat started hurting /  sore throat), PAIN IN EXTREMITY (arm sore,), RHINORRHOEA (and the one that aren't supper common, like  running nose), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue,tired) and HEADACHE (headache). On 25-Nov-2021, the patient experienced ILLNESS (she is  still sick), NASAL CONGESTION (nose still stuff) and SNEEZING (nose starting running and started sneezing). In 2021, NASAL CONGESTION (nose still stuff) and OROPHARYNGEAL PAIN (throat started hurting /  sore throat) outcome was unknown, SNEEZING (nose starting running and started sneezing) had resolved. On 25-Nov-2021, PAIN IN EXTREMITY (arm sore,), RHINORRHOEA (and the one that aren't supper common, like  running nose), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue,tired) and HEADACHE (headache) had resolved. At the time of the report, ILLNESS (she is  still sick) had not resolved.            Treatment details was not reported by the reporter.   This case was linked to MOD-2021-397570, MOD-2021-397552 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasal congestion, Pain, Pyrexia
Clinical narrative: congested; aches and pains; fever,highest 99.9; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested), PAIN (aches and pains), PYREXIA (fever,highest 99.9) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 0Z4M20A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congested), PAIN (aches and pains), PYREXIA (fever,highest 99.9) and CHILLS (chills). At the time of the report, NASAL CONGESTION (congested), PAIN (aches and pains) and CHILLS (chills) outcome was unknown and PYREXIA (fever,highest 99.9) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: Back pain; Low back muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and MYALGIA (Low back muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced BACK PAIN (Back pain) and MYALGIA (Low back muscle pain). In November 2021, BACK PAIN (Back pain) had resolved. At the time of the report, MYALGIA (Low back muscle pain) had not resolved.            No concomitant medications were provided.  No treatment medications were reported.  Patient had been experiencing low back muscle pain since 2-3 weeks.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Strong pain in left arm from shoulder to wrist; Immediately following arm went numb; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Strong pain in left arm from shoulder to wrist) and HYPOAESTHESIA (Immediately following arm went numb) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Strong pain in left arm from shoulder to wrist) and HYPOAESTHESIA (Immediately following arm went numb). At the time of the report, PAIN IN EXTREMITY (Strong pain in left arm from shoulder to wrist) and HYPOAESTHESIA (Immediately following arm went numb) outcome was unknown. Not Provided    No concomitant information was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-387323 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Hypoaesthesia, Paraesthesia
Clinical narrative: slight numbness in my cheeks/then nose and face/It spread to the area behind my jaw and ears; some sensitivity in my teeth; I felt a tingling/ slight numbness in my cheeks, then nose and face; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (slight numbness in my cheeks/then nose and face/It spread to the area behind my jaw and ears), HYPERAESTHESIA TEETH (some sensitivity in my teeth) and PARAESTHESIA (I felt a tingling/ slight numbness in my cheeks, then nose and face) in a patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (slight numbness in my cheeks/then nose and face/It spread to the area behind my jaw and ears), HYPERAESTHESIA TEETH (some sensitivity in my teeth) and PARAESTHESIA (I felt a tingling/ slight numbness in my cheeks, then nose and face). At the time of the report, HYPOAESTHESIA (slight numbness in my cheeks/then nose and face/It spread to the area behind my jaw and ears), HYPERAESTHESIA TEETH (some sensitivity in my teeth) and PARAESTHESIA (I felt a tingling/ slight numbness in my cheeks, then nose and face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: dizziness; was sick for three days/sick sick/she was more sick/though up and all of the above; having the flu for a couple of days; diarrhea; felt rush and a fatigue very fast, tired; Nausea; fever/ really bad fever and went away after 3 days; vomiting; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea) and FATIGUE (felt rush and a fatigue very fast, tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20a and 027L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea), FATIGUE (felt rush and a fatigue very fast, tired), NAUSEA (Nausea), PYREXIA (fever/ really bad fever and went away after 3 days), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 06-Mar-2021, DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea), FATIGUE (felt rush and a fatigue very fast, tired), NAUSEA (Nausea), PYREXIA (fever/ really bad fever and went away after 3 days), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved.            Treatment medications were not provided.  It was reported that patient did not had swollen glandes and throat didn't hurt so bad.   This case was linked to MOD-2021-397570, MOD-2021-397419 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Nausea, Pyrexia, Vomiting
Clinical narrative: dizziness; was sick for three days/sick sick/she was more sick/though up and all of the above; having the flu for a couple of days; diarrhea; felt rush and a fatigue very fast, tired; Nausea; fever/ really bad fever and went away after 3 days; vomiting; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea) and FATIGUE (felt rush and a fatigue very fast, tired) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20a and 027L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea), FATIGUE (felt rush and a fatigue very fast, tired), NAUSEA (Nausea), PYREXIA (fever/ really bad fever and went away after 3 days), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). On 06-Mar-2021, DIZZINESS (dizziness), ILLNESS (was sick for three days/sick sick/she was more sick/though up and all of the above), INFLUENZA (having the flu for a couple of days), DIARRHOEA (diarrhea), FATIGUE (felt rush and a fatigue very fast, tired), NAUSEA (Nausea), PYREXIA (fever/ really bad fever and went away after 3 days), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had resolved.            Treatment medications were not provided.  It was reported that patient did not had swollen glandes and throat didn't hurt so bad.   This case was linked to MOD-2021-397570, MOD-2021-397419 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I had a severe headache the night of the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I had a severe headache the night of the booster dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 007B21A and 046B21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.   Concomitant products included PREGABALIN (LYRICA), GABAPENTIN, BUSPIRONE, CLONAZEPAM and MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (I had a severe headache the night of the booster dose). At the time of the report, HEADACHE (I had a severe headache the night of the booster dose) had resolved.      Treatment information was not provided by the reporter.   This case was linked to MOD-2021-085633, MOD-2021-085673 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Is a temp a side effect; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Is a temp a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Is a temp a side effect). At the time of the report, ADVERSE EVENT (Is a temp a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Peripheral swelling, Pyrexia, Renal pain
Clinical narrative: pain like someone is jabbing my back; acute kidney pain; swollen right arm; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain like someone is jabbing my back), RENAL PAIN (acute kidney pain), PERIPHERAL SWELLING (swollen right arm) and PYREXIA (Feverish) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain like someone is jabbing my back), RENAL PAIN (acute kidney pain), PERIPHERAL SWELLING (swollen right arm) and PYREXIA (Feverish). At the time of the report, BACK PAIN (pain like someone is jabbing my back) had not resolved and RENAL PAIN (acute kidney pain), PERIPHERAL SWELLING (swollen right arm) and PYREXIA (Feverish) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Infection
Clinical narrative: Got the breakthrough case and they both quarantine; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Got the breakthrough case and they both quarantine) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced INFECTION (Got the breakthrough case and they both quarantine) and HEADACHE (Headache). On 14-Oct-2021, HEADACHE (Headache) had resolved. On 28-Oct-2021, INFECTION (Got the breakthrough case and they both quarantine) had resolved.            No concomitant medications were provided. No treatment medications were reported.  This is a Spontaneous case concerning a male patient  of unknown age and unknwon medical history,  who experienced the unexpected non serious (AESI) event of Breakthrough infection. The event occurred approximately 5 months and 22 days after the second dose of mRNA 1273 vaccine. Patient was reported to had a breakthrough infection and refered that he had to quarantine but was unwilling to give more details regarding the definite diagnosis or diagnostic lab data regarding this infection that could confirm the case was refering to a COVID 19 breakthrough infection.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a male patient  of unknown age and unknwon medical history,  who experienced the unexpected non serious (AESI) event of Breakthrough infection. The event occurred approximately 5 months and 22 days after the second dose of mRNA 1273 vaccine. Patient was reported to had a breakthrough infection and refered that he had to quarantine but was unwilling to give more details regarding the definite diagnosis or diagnostic lab data regarding this infection that could confirm the case was refering to a COVID 19 breakthrough infection.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vial that was at room temperature since  the 23Nov2021.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Nov-2021 and was forwarded to Moderna on 27-Nov-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.). On 26-Nov-2021, PRODUCT STORAGE ERROR (vial that was at room temperature since  the 23Nov2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: in the same  arm of the injection, swelling in that area; it is hurting in armpit area in the same arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (in the same  arm of the injection, swelling in that area) and VACCINATION SITE PAIN (it is hurting in armpit area in the same arm of the injection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031h21a, 027c21a and 042b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced VACCINATION SITE SWELLING (in the same  arm of the injection, swelling in that area) and VACCINATION SITE PAIN (it is hurting in armpit area in the same arm of the injection). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (in the same  arm of the injection, swelling in that area) and VACCINATION SITE PAIN (it is hurting in armpit area in the same arm of the injection) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Insomnia, Pain
Clinical narrative: was hurting so bad, body ache; usually doesn't sleep good, and took two more Tylenol and doze off; worst headache,head was about to burst open; temperature  normally is 97.4°f and their temperature was 100.2°F; got chills,real bad chills,but body didn't felt warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off), CHILLS (got chills,real bad chills,but body didn't felt warm), HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 022m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, METHIMAZOLE, SIMVASTATIN, SALBUTAMOL SULFATE (PROAIR DIGIHALER), FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), DIPHENHYDRAMINE and METFORMIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (got chills,real bad chills,but body didn't felt warm). On 23-Nov-2021, the patient experienced PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off), HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F) had resolved. At the time of the report, PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off) and CHILLS (got chills,real bad chills,but body didn't felt warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Body temperature: 100.2 (High) 100.2 Degree F.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: was hurting so bad, body ache; usually doesn't sleep good, and took two more Tylenol and doze off; worst headache,head was about to burst open; temperature  normally is 97.4°f and their temperature was 100.2°F; got chills,real bad chills,but body didn't felt warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off), CHILLS (got chills,real bad chills,but body didn't felt warm), HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007b21a and 022m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, METHIMAZOLE, SIMVASTATIN, SALBUTAMOL SULFATE (PROAIR DIGIHALER), FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), DIPHENHYDRAMINE and METFORMIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (got chills,real bad chills,but body didn't felt warm). On 23-Nov-2021, the patient experienced PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off), HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, HEADACHE (worst headache,head was about to burst open) and PYREXIA (temperature  normally is 97.4°f and their temperature was 100.2°F) had resolved. At the time of the report, PAIN (was hurting so bad, body ache), INSOMNIA (usually doesn't sleep good, and took two more Tylenol and doze off) and CHILLS (got chills,real bad chills,but body didn't felt warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Body temperature: 100.2 (High) 100.2 Degree F.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Sever chronic  fatigue; Chronic joint pain; Chronic  muscle pain, that  has lessen is not that  severe; Her life has been turn up side down; Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away; Having  back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away), BACK PAIN (Having  back pain), FATIGUE (Sever chronic  fatigue) and ARTHRALGIA (Chronic joint pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 012l20a and 010m20a.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away) and BACK PAIN (Having  back pain). On 23-Nov-2021, the patient experienced FATIGUE (Sever chronic  fatigue), ARTHRALGIA (Chronic joint pain) and MYALGIA (Chronic  muscle pain, that  has lessen is not that  severe). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. On 23-Nov-2021, BACK PAIN (Having  back pain) had resolved. At the time of the report, FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away), FATIGUE (Sever chronic  fatigue), ARTHRALGIA (Chronic joint pain) and MYALGIA (Chronic  muscle pain, that  has lessen is not that  severe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-398471 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Sever chronic  fatigue; Chronic joint pain; Chronic  muscle pain, that  has lessen is not that  severe; Her life has been turn up side down; Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away; Having  back pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away), BACK PAIN (Having  back pain), FATIGUE (Sever chronic  fatigue) and ARTHRALGIA (Chronic joint pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 012l20a and 010m20a.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away) and BACK PAIN (Having  back pain). On 23-Nov-2021, the patient experienced FATIGUE (Sever chronic  fatigue), ARTHRALGIA (Chronic joint pain) and MYALGIA (Chronic  muscle pain, that  has lessen is not that  severe). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. On 23-Nov-2021, BACK PAIN (Having  back pain) had resolved. At the time of the report, FEELING ABNORMAL (Her life has been turn up side down), URTICARIA (Is having spontaneous  chronic hive this, all day long scratching,  100% from booster, cant live her life like this, is on prednisone and has read in internet this  doesn't go away), FATIGUE (Sever chronic  fatigue), ARTHRALGIA (Chronic joint pain) and MYALGIA (Chronic  muscle pain, that  has lessen is not that  severe) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-398471 (Patient Link).
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Headache, Nausea, Pyrexia
Clinical narrative: Lack of appetite; Fever of 100.5F°; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), PYREXIA (Fever of 100.5F°), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old patient of an unknown gender 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 third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Lack of appetite), PYREXIA (Fever of 100.5F°), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DECREASED APPETITE (Lack of appetite), PYREXIA (Fever of 100.5F°), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5F°.         No concomitant and treatment medications were provided. The patient reported that they don't have any pre-existing conditions.   This case was linked to MOD-2021-398590.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: symptoms with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms with the first 2 doses) in a 53-year-old female patient 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, the patient experienced VACCINATION COMPLICATION (symptoms with the first 2 doses). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (symptoms with the first 2 doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.   This case was linked to MOD-2021-398464, MOD-2021-398524 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Heart rate, Pyrexia
Clinical narrative: around 9 she said she started to feel bad; low grade fever; chills; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (around 9 she said she started to feel bad), PYREXIA (low grade fever) and CHILLS (chills) 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 28-Nov-2021, the patient experienced FEELING ABNORMAL (around 9 she said she started to feel bad), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (around 9 she said she started to feel bad), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Heart rate: 105 (High) heart rate progressively went up to 105 then 130 then she woke up and it was150 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of DEPRESSED MOOD (disappointed To have) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (disappointed To have). At the time of the report, DEPRESSED MOOD (disappointed To have) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling on the toes after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on the toes after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 an unknown date, the patient experienced PARAESTHESIA (Tingling on the toes after second dose). At the time of the report, PARAESTHESIA (Tingling on the toes after second dose) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-398550 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling on the toes after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling on the toes after the booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third 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. In November 2021, the patient experienced PARAESTHESIA (tingling on the toes after the booster dose). At the time of the report, PARAESTHESIA (tingling on the toes after the booster dose) had not resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-398540 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling area gland up to his neck, but has gone away on him; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling area gland up to his neck, but has gone away on him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swelling area gland up to his neck, but has gone away on him). At the time of the report, LYMPHADENOPATHY (swelling area gland up to his neck, but has gone away on him) had resolved.            No concomitant drug details were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) had resolved.            Concomitant medications details were not reported by the reporter.  Treatment Included took muscle relaxant and prescribed pain medication but still sore and painful.  Events recovered after resting.   This case was linked to MOD-2021-398431 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she had a major  issue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a major  issue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she had a major  issue). At the time of the report, VACCINATION COMPLICATION (she had a major  issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives in all over her body ( urticaria ) like red welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives in all over her body ( urticaria ) like red welts) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCORTISONE for an unknown indication.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (Hives in all over her body ( urticaria ) like red welts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 27-Nov-2021 for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives in all over her body ( urticaria ) like red welts) outcome was unknown.            Other concomitant product use included meclatzon.