chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Irritability, Myalgia
Clinical narrative: cant eat because she throws up nausea; Fever; Chills; Headache; felt annoying; body aches; tired; Arm of the injection hurt; was a bit swollen; A spontaneous report was received from a consumer concerning a 33-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm of the injection hurt, a bit swollen, body aches, felt annoying, tired, fever, chills, headache and cant eat because she throws up.  The patient's medical history was not provided. Concomitant medications were reported as metformin, medicine for cholesterol and triglycerides, gabapentin, valprax and other psychopharmacology drugs.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly  in an unknown location for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events arm of the injection hurt and a bit swollen. On 18 Feb 2021, the patient experienced the events body aches, felt annoying, tired. On 20 Feb 2021, the patient experienced the events fever, chills, headache, cant eat because she throws up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm of the injection hurt, a bit swollen, body aches, felt annoying, tired, fever, chills, headache, cant eat because she throws up was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: cant eat because she throws up nausea; Fever; Chills; Headache; felt annoying; body aches; tired; Arm of the injection hurt; was a bit swollen; A spontaneous report was received from a consumer concerning a 33-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm of the injection hurt, a bit swollen, body aches, felt annoying, tired, fever, chills, headache and cant eat because she throws up.  The patient's medical history was not provided. Concomitant medications were reported as metformin, medicine for cholesterol and triglycerides, gabapentin, valprax and other psychopharmacology drugs.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly  in an unknown location for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events arm of the injection hurt and a bit swollen. On 18 Feb 2021, the patient experienced the events body aches, felt annoying, tired. On 20 Feb 2021, the patient experienced the events fever, chills, headache, cant eat because she throws up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm of the injection hurt, a bit swollen, body aches, felt annoying, tired, fever, chills, headache, cant eat because she throws up was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Swelling, Vaccination site pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (lump), VACCINATION SITE PAIN (felt like someone socked me in the arm/sore) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no adverse events were reported). Concomitant products included DUPILUMAB (DUPIXENT), IRBESARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced SWELLING (lump) and VACCINATION SITE PAIN (felt like someone socked me in the arm/sore). On 15-Jan-2021, the patient experienced FATIGUE (Tired). On 15-Jan-2021, SWELLING (lump) and VACCINATION SITE PAIN (felt like someone socked me in the arm/sore) had resolved. On 16-Jan-2021, FATIGUE (Tired) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-057867.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pain, Rhinorrhoea
Clinical narrative: Nasal drainage; body pain; nausea; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nasal drainage), ARTHRALGIA (sore shoulder), PAIN (body pain) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0252264) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder). On an unknown date, the patient experienced RHINORRHOEA (Nasal drainage), PAIN (body pain) and NAUSEA (nausea). On 25-Jan-2021, ARTHRALGIA (sore shoulder) outcome was unknown. At the time of the report, RHINORRHOEA (Nasal drainage), PAIN (body pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received vitamin C as a treatment,
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Myalgia, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (very large red going all top of her arm, had like a dark red border), MYALGIA (sore arm), ARTHRALGIA (soreness was much more intense on her shoulder too) and VACCINATION SITE ERYTHEMA (red mark at the injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (sore arm). On 27-Jan-2021, the patient experienced ERYTHEMA (very large red going all top of her arm, had like a dark red border). On an unknown date, the patient experienced ARTHRALGIA (soreness was much more intense on her shoulder too) and VACCINATION SITE ERYTHEMA (red mark at the injection site). On 18-Jan-2021, MYALGIA (sore arm) had resolved. At the time of the report, ERYTHEMA (very large red going all top of her arm, had like a dark red border) had not resolved and ARTHRALGIA (soreness was much more intense on her shoulder too) and VACCINATION SITE ERYTHEMA (red mark at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported concomitant medication of an antidepressant, not otherwise specified. Treatment taken by the patient was Ibuprofen for soreness and occasionally pills for allergic reaction.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm was very sore; Pain goes from the top of her shoulder and into/ all around the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore) and PAIN (Pain goes from the top of her shoulder and into/ all around the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore) and PAIN (Pain goes from the top of her shoulder and into/ all around the arm). At the time of the report, PAIN IN EXTREMITY (Arm was very sore) and PAIN (Pain goes from the top of her shoulder and into/ all around the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness; Itchiness; A spontaneous report was received on 3 Feb 2021, from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) redness, itchiness.  Treatment details included Tylenol rapid release gel cap, Hydrocortisone 1%.  Action taken with mRNA-1273 in response to the events was not reported.  On 4 Feb 2021 the outcome of event(s), redness, itchiness was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: The spot was warm; The spot was itchy; Red spot (the size of an egg) on her arm close to the injection site; Injection site hurt a little on the next day following the vaccination; A spontaneous report was received from a consumer, concerning herself, a 73-year-old female patient who received Moderna's COVID-19 vaccine and developed the spot was warm, the spot was itchy, red spot (the size of an egg) on her arm close to the injection site and injection site hurt a little on the next day following the vaccination.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 14 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscular in her left upper arm for prophylaxis of Covid-19 infection.  On 15 Jan 2021, the next day following vaccine administration, the patient's injection site was a little hurt. On 21 Jan 2021, the patient developed red itchy and warm spot (the size of an egg) on her arm close to the injection site which disappeared after two days. The patient did not take any treatment medication for events.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, spot was warm, the spot was itchy, red spot (the size of an egg) on her arm close to the injection site were considered resolved on 23 Jan 2021. The outcome of event injection site hurt a little on the next day following the vaccination was considered resolved on an unspecified date in 2021.; Reporter's Comments: This case concerns a 73-year-old female who experienced a NS unexpected events of vaccination site warmth and NS expected events of vaccination site pruritus, vaccination site erythema, and vaccination site pain.  The events occurred 8 days after the first dose of mRNA-1273. Event outcomes resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Visual impairment
Clinical narrative: Tingling in my tongue; spots before my eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling in my tongue) and VISUAL IMPAIRMENT (spots before my eyes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K020A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included PREDNISONE.    On 15-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 PARAESTHESIA ORAL (Tingling in my tongue) and VISUAL IMPAIRMENT (spots before my eyes). At the time of the report, PARAESTHESIA ORAL (Tingling in my tongue) and VISUAL IMPAIRMENT (spots before my eyes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Huge swelling in arm at injection site; Huge red area around injection site; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events huge swelling in arm at injection site, huge red area around injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced the event(s) huge swelling in arm at injection site, huge red area around injection site.  Treatment details included ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), huge swelling in arm at injection site, huge red area around injection site was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: has gotten COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (has gotten COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     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 COVID-19 (has gotten COVID). At the time of the report, COVID-19 (has gotten COVID) 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 and  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: NNI - No New Information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Fatigue
Clinical narrative: diarrhea; bruising; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising), FATIGUE (fatigued) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced CONTUSION (bruising) and FATIGUE (fatigued). On 29-Jan-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, CONTUSION (bruising), FATIGUE (fatigued) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking blood thinners.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia
Clinical narrative: Sore arm; Muscle ache where the injection was, at the site; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/ pain in the extremity, the patient reported a muscle ache muscle ache where the injection was, at the site/ myalgia.  The patient's medical history included lung transplant in 2009. Concomitant medications reported were Alotyrenol, Entecavar, Indapamide, Losartan, Metoprolol, Losedapine, Tacrolimus for lung transplant.  On 6 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events sore arm, The patient reported a muscle ache muscle ache where the injection was, at the site.  Treatment details included none.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The outcome of events, sore arm, the patient reported a muscle ache muscle ache where the injection was, at the site was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching injection site; Reddish pink injection site; Pain in her arm; A spontaneous report was received from a consumer concerning an 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events reddish pink injection site/ vaccination site erythema, itching injection site/ vaccination site pruritus, pain in her arm/ pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, approximately one day prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event pain in her arm. On 22 Feb 2021, the patient experienced the events reddish pink injection site, itching injection site.   Treatment details included Ice, Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. On 21 Feb 2021 the outcome of events pain in her arm was resolved. The outcome of events, reddish pink injection site, itching injection site was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness in arm of injection site; Redness in arm of injection site; Hotness in arm of injection site; Tener in arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in arm of injection site), INJECTION SITE ERYTHEMA (Redness in arm of injection site), INJECTION SITE WARMTH (Hotness in arm of injection site) and INJECTION SITE PAIN (Tener in arm of injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided). Concomitant products included ANASTROZOLE, CITALOPRAM, ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO), HYDROCODONE, THYROID and PANTOPRAZOLE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness in arm of injection site), INJECTION SITE ERYTHEMA (Redness in arm of injection site), INJECTION SITE WARMTH (Hotness in arm of injection site) and INJECTION SITE PAIN (Tener in arm of injection site). On 22-Jan-2021, INJECTION SITE PAIN (Soreness in arm of injection site) outcome was unknown. On 31-Jan-2021, INJECTION SITE ERYTHEMA (Redness in arm of injection site), INJECTION SITE WARMTH (Hotness in arm of injection site) and INJECTION SITE PAIN (Tener in arm of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Broken up red in his arm; Rash in both arms and chest; A spontaneous report was received from a consumer concerning a 38-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events broken up red/ erythema, rash in both arms and chest/ rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events broken up red, rash in both arms and chest.  The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, broken up red, rash in both arms and chest was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Dizzy; Weak; Fever that reads 102.3F; Feeling very sick; Injection site was hot to touch; Arm pain; A spontaneous report was received from a consumer concerning a 21-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain/pain in extremity, injection site was hot to touch/ Vaccination site warmth, feeling very sick/malaise, dizzy/ dizziness, weak/ asthenia, fever that reads 102.3F/ pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events arm pain, injection site was hot to touch. On 21 Feb 2021, the patient experienced the events feeling very sick, dizzy, weak, fever that reads 102.3F.  Treatment details included Tylenol 650mg.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The outcome of events, arm pain, injection site was hot to touch, feeling very sick, dizzy, weak, was unknown. The outcome of event fever that reads 102, 3F was not resolved.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Dizzy; Weak; Fever that reads 102.3F; Feeling very sick; Injection site was hot to touch; Arm pain; A spontaneous report was received from a consumer concerning a 21-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain/pain in extremity, injection site was hot to touch/ Vaccination site warmth, feeling very sick/malaise, dizzy/ dizziness, weak/ asthenia, fever that reads 102.3F/ pyrexia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 20 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the events arm pain, injection site was hot to touch. On 21 Feb 2021, the patient experienced the events feeling very sick, dizzy, weak, fever that reads 102.3F.  Treatment details included Tylenol 650mg.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The outcome of events, arm pain, injection site was hot to touch, feeling very sick, dizzy, weak, was unknown. The outcome of event fever that reads 102, 3F was not resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and NASAL CONGESTION (Stuffy nose feeling like I have a cold) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Feb-2021, the patient experienced NASAL CONGESTION (Stuffy nose feeling like I have a cold). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, NASAL CONGESTION (Stuffy nose feeling like I have a cold) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No further information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Disorientation, Nausea, Vomiting
Clinical narrative: bad diarrhea; extremely weak; slightly disoriented; nausea real bad; threw up stone black liquid; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad diarrhea), ASTHENIA (extremely weak), DISORIENTATION (slightly disoriented), NAUSEA (nausea real bad) and VOMITING (threw up stone black liquid) in a 70-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (bad diarrhea), ASTHENIA (extremely weak), DISORIENTATION (slightly disoriented), NAUSEA (nausea real bad) and VOMITING (threw up stone black liquid). At the time of the report, DIARRHOEA (bad diarrhea), ASTHENIA (extremely weak), DISORIENTATION (slightly disoriented), NAUSEA (nausea real bad) and VOMITING (threw up stone black liquid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Heart rate, Pain in extremity, Pulse abnormal
Clinical narrative: 110-115 pulse rate; Pain in the left arm (8 out of 10 pain); Brain fog; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm (8 out of 10 pain)), CONFUSIONAL STATE (Brain fog) and PULSE ABNORMAL (110-115 pulse rate) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm (8 out of 10 pain)) and CONFUSIONAL STATE (Brain fog). On an unknown date, the patient experienced PULSE ABNORMAL (110-115 pulse rate). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in the left arm (8 out of 10 pain)) and CONFUSIONAL STATE (Brain fog) had resolved. At the time of the report, PULSE ABNORMAL (110-115 pulse rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Heart rate: 110-115 pulse rate.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-128001 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128001:Same patient (2nd dose)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Insomnia, Malaise, Nasal congestion
Clinical narrative: No appetite; Weakness; Congestion; Excruciating sinus headache; Not feeling good; Didn't sleep well; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events not feeling good/ malaise, didn't sleep well/ insomnia, excruciating sinus headache/ sinus headache, no appetite/ decreased appetite, weakness/ asthenia, congestion/ nasal congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, approximately 1 day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events not feeling good, didn't sleep well. On 13 Feb 2021, the patient experienced the events excruciating sinus headache. On an unknown date, the patient experienced the events no appetite, weakness, congestion.  Treatment details included Musinex sinus tablets.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, not feeling good, didn't sleep well, excruciating sinus headache, no appetite, weakness, congestion was not resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: No appetite; Weakness; Congestion; Excruciating sinus headache; Not feeling good; Didn't sleep well; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events not feeling good/ malaise, didn't sleep well/ insomnia, excruciating sinus headache/ sinus headache, no appetite/ decreased appetite, weakness/ asthenia, congestion/ nasal congestion.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, approximately 1 day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events not feeling good, didn't sleep well. On 13 Feb 2021, the patient experienced the events excruciating sinus headache. On an unknown date, the patient experienced the events no appetite, weakness, congestion.  Treatment details included Musinex sinus tablets.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, not feeling good, didn't sleep well, excruciating sinus headache, no appetite, weakness, congestion was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: A rash all over the arm; a red area at the arm that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash all over the arm) and PRURITUS (a red area at the arm that is itchy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH (A rash all over the arm) and PRURITUS (a red area at the arm that is itchy). At the time of the report, RASH (A rash all over the arm) and PRURITUS (a red area at the arm that is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling, Muscle tightness
Clinical narrative: Huge Knot; swelling; itchiness; Tightness; Tenderness; A spontaneous report was received from a consumer concerning a 45-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness/injection site pain, huge knot/injection site mass, swelling/injection site swelling, itchiness/injection site pruritus, tightness/muscle tightness.  The patient's medical history was not provided. Concomitant medications reported were medroxy progestrone, Bladder Pills., Menopause Medications for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) tenderness. On 19 Feb 2021, the patient experienced the event(s) huge knot, swelling, itchiness, tightness.  Treatment details included Ibuprofen and diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tenderness, huge knot, swelling, itchiness, tightness was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Pain
Clinical narrative: Dizziness; Redness; Pain; Dizziness; Redness; Pain; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DIZZINESS (Dizziness), the first episode of ERYTHEMA (Redness), the first episode of PAIN (Pain), the second episode of DIZZINESS (Dizziness) and the second episode of ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of DIZZINESS (Dizziness), the first episode of ERYTHEMA (Redness) and the first episode of PAIN (Pain). On 17-Feb-2021, the patient experienced the second episode of DIZZINESS (Dizziness), the second episode of ERYTHEMA (Redness) and the second episode of PAIN (Pain). At the time of the report, last episode of DIZZINESS (Dizziness), the last episode of ERYTHEMA (Redness) and the last episode of PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Upon internal review on 07 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was incorrect, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness; swelling; itching at the injection site; Redness; swelling; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), the first episode of VACCINATION SITE SWELLING (swelling), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (redness) and the second episode of VACCINATION SITE SWELLING (swelling) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), the first episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itchiness at the injection site). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), the second episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itching at the injection site). On 21-Jan-2021, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (itchiness at the injection site) had not resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness), the last episode of VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Rash, Swelling
Clinical narrative: shingles; rash over their neck and upper back on the opposite side; with a little rash; was swollen on the bicep area; arm was sore immediately; A spontaneous report was received from a caregiver concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore immediately/pain in extremity, and was swollen on the bicep area/swelling, with a little rash/rash, rash over their neck and upper back on the opposite side/rash, shingles /herpes zoster.  The patient's medical history was not provided. Concomitant medications reported were 0.5 mg lorazepam, 10mg amitriptyline, 5mg Lisinopril for drug use for unknown indication.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) arm was sore immediately, and was swollen on the bicep area, with a little rash. On 12 Feb 2021, the patient experienced the event(s) rash over their neck and upper back on the opposite side.  Treatment details included Topical treatment  for the initial rash., Valacyclovir for the shingles.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was sore immediately, and was swollen on the bicep area, with a little rash, rash over their neck and upper back on the opposite side,shingles was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Upset stomach; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol 2 hours before receiving the vaccine.  Concomitant medications were not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Peripheral swelling
Clinical narrative: Right arm pit swollen (feels like fluid retention); Lymph nodes tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm pit swollen (feels like fluid retention)) and LYMPH NODE PAIN (Lymph nodes tenderness) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (Right arm pit swollen (feels like fluid retention)) and LYMPH NODE PAIN (Lymph nodes tenderness). At the time of the report, PERIPHERAL SWELLING (Right arm pit swollen (feels like fluid retention)) and LYMPH NODE PAIN (Lymph nodes tenderness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Heart rate increased, Hypertension, Hypoaesthesia, Swelling face
Clinical narrative: fast heart beat; high blood pressure; my nose and left ear got kind of numb; facial swelling; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (my nose and left ear got kind of numb) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient is under medication). Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT ALLERGO), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), ATORVASTATIN CALCIUM (LIPITOR), ATORVASTATIN, FAMOTIDINE (PEPCID AC), VITAMIN D3, BIOTIN and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HYPOAESTHESIA (my nose and left ear got kind of numb). At the time of the report, HYPOAESTHESIA (my nose and left ear got kind of numb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Computerised tomogram: normal (normal) Went to ER, they run a CT scan on me because they thought it was a stroke, but they said it was OK. It might have been Bell's Palsy..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-jul-2021 contains No new information
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus issue; A spontaneous report (United States) was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus issue/sinusitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sinus issue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sinus issue, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Myalgia
Clinical narrative: Stomach was hurting; Joint pain; Muscle pain; Fever about 100Degrees; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment  for the event includes Tylenol.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Stomach was hurting; Joint pain; Muscle pain; Fever about 100Degrees; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment  for the event includes Tylenol.