chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Sensation of foreign body
Clinical narrative: Lump in throat comes and goes; Lump in the throat; Hot neck; throat was also red hot, I mean my neck; Severe chills; This spontaneous case was reported by a physician and describes the occurrence of SENSATION OF FOREIGN BODY (Lump in the throat), FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck), CHILLS (Severe chills) and SENSATION OF FOREIGN BODY (Lump in throat comes and goes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), METOPROLOL, ATORVASTATIN and MELATONIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced SENSATION OF FOREIGN BODY (Lump in the throat), FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck) and CHILLS (Severe chills). On an unknown date, the patient experienced SENSATION OF FOREIGN BODY (Lump in throat comes and goes). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at an unspecified dose and frequency. On 31-Jan-2021, SENSATION OF FOREIGN BODY (Lump in the throat) and CHILLS (Severe chills) had resolved. At the time of the report, FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck) and SENSATION OF FOREIGN BODY (Lump in throat comes and goes) 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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Telephone contact report attached.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Myalgia
Clinical narrative: chills; body aches; stomach issues; A Spontaneous case was received from consumer, concerning a female patient and age 53, who received Moderna's COVID-19 vaccine experienced Chills, Myalgia/ body aches, Abdominal discomfort/ stomach issues.  The patient's medical history was not provided. The Patient's concomitant medications were singulair, Pepcid, Claritin, fish, oil, zinc, collagen.  On 11Jan2021 , prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : 012L20A) via unspecified route for COVID-19 infection prophylaxis.  On 09Feb2021 , prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (Batch number : 029L20A) via unspecified route for COVID-19 infection prophylaxis.   On an unknown date, she experienced severe chills, body aches, stomach issues and severe congestion.  Since the patient had already taken both the scheduled doses of vaccine, the action taken in response to the events, Chills, Myalgia, Abdominal discomfort was not applicable.  The outcome of the event, Chills, Myalgia, Abdominal discomfort Vaccination site rash was considered to be unknown.  The treatment medications reported to be taken by the patient was Voltaren.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: arm puffy; arm red; arm itchy; arm hot; arm was sore; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain (arm puffy), vaccination site erythema (arm red), peripheral swelling (arm was sore),  vaccination site pruritus (arm itchy) and vaccination site warmth ( arm hot).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient reported experiencing arm was sore. On 7 Feb 2021, the patient experienced the events of arm red, arm puffy, arm itchy and arm hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 30 Jan 2021 the outcome of event, arm was sore was resolved. The outcome of events, arm red, arm puffy, arm itchy, arm hot was unknown.  Based on MSA comment, change listedness to listed and unlisted for monograph and factsheet
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye irritation, Headache, Myalgia
Clinical narrative: fever; chills; headache in her eyes; eyes feel glassy and watery; arm started hurting immensely; pain in arm, neck, small of back; pain in shoulders, knees; Knot under the skin; knot higher up on shoulder; Red rash in a circle under where he put the medicine in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees). On 03-Feb-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (arm started hurting immensely). On 04-Feb-2021, the patient experienced EYE IRRITATION (eyes feel glassy and watery), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache in her eyes). At the time of the report, VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever), CHILLS (chills), HEADACHE (headache in her eyes), VACCINATION SITE PAIN (arm started hurting immensely), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees) had not resolved.            Treatment for the events included paracetamol and ice on the affected arm.   No concomitant medication were provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: fever; chills; headache in her eyes; eyes feel glassy and watery; arm started hurting immensely; pain in arm, neck, small of back; pain in shoulders, knees; Knot under the skin; knot higher up on shoulder; Red rash in a circle under where he put the medicine in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees). On 03-Feb-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (arm started hurting immensely). On 04-Feb-2021, the patient experienced EYE IRRITATION (eyes feel glassy and watery), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache in her eyes). At the time of the report, VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever), CHILLS (chills), HEADACHE (headache in her eyes), VACCINATION SITE PAIN (arm started hurting immensely), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees) had not resolved.            Treatment for the events included paracetamol and ice on the affected arm.   No concomitant medication were provided.; 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: mild fever; Tired; headaches; A spontaneous report was received from a consumer concerning himself, who is a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild fever, tired, headaches.  The patient's medical history was not provided. Concomitant medications reported were insulin, gavapentin for drug use for unknown indication.  On 07 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced the events mild fever, tired, headaches.  Treatment details included ibuprofen.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  On 09 Feb 2021 the outcome of events mild fever, tired, headaches was resolved.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching Injection Site; Swollen Injection Site; Red Injection Site; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching injection site, swollen injection site, red injection site.  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 first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) itching injection site, swollen injection site, red injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itching injection site, swollen injection site, red injection site was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Dehydration, Ear pain, Fatigue
Clinical narrative: extreme swelling of lymph node; swelling on in the injection arm/swelling on left arm; swelling of neck; swelling on the face; pain; pain inside of left ear; swelling on in the injection arm/swelling on left arm; rash on lower extremity of both leg more towards upper calf and lower thigh side; lost sense of taste; dehydrate; lack of appetite; fatigue for 4 days; A spontaneous report was received from a consumer concerning herself, who is a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme swelling of lymph node, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, fatigue for 4 days.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events in evening with extreme swelling of lymph node, swelling of neck, swelling on in the injection arm as well as swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, and fatigue for 4 days.  Treatment details included diphenhydramine: for 2 days, acetaminophen, dextromethorphan, and phenylephrine 1/ 2 recommended dose listed on the bottle for 3 days.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  On 9 Feb 2021 the outcome of event pain inside of left ear, fatigue for 4 days was resolved. The outcome of events extreme swelling of lymph node, swelling of neck, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Peripheral swelling, Rash, Swelling
Clinical narrative: extreme swelling of lymph node; swelling on in the injection arm/swelling on left arm; swelling of neck; swelling on the face; pain; pain inside of left ear; swelling on in the injection arm/swelling on left arm; rash on lower extremity of both leg more towards upper calf and lower thigh side; lost sense of taste; dehydrate; lack of appetite; fatigue for 4 days; A spontaneous report was received from a consumer concerning herself, who is a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme swelling of lymph node, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, fatigue for 4 days.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events in evening with extreme swelling of lymph node, swelling of neck, swelling on in the injection arm as well as swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, and fatigue for 4 days.  Treatment details included diphenhydramine: for 2 days, acetaminophen, dextromethorphan, and phenylephrine 1/ 2 recommended dose listed on the bottle for 3 days.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  On 9 Feb 2021 the outcome of event pain inside of left ear, fatigue for 4 days was resolved. The outcome of events extreme swelling of lymph node, swelling of neck, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site swelling
Clinical narrative: extreme swelling of lymph node; swelling on in the injection arm/swelling on left arm; swelling of neck; swelling on the face; pain; pain inside of left ear; swelling on in the injection arm/swelling on left arm; rash on lower extremity of both leg more towards upper calf and lower thigh side; lost sense of taste; dehydrate; lack of appetite; fatigue for 4 days; A spontaneous report was received from a consumer concerning herself, who is a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme swelling of lymph node, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, fatigue for 4 days.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events in evening with extreme swelling of lymph node, swelling of neck, swelling on in the injection arm as well as swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, and fatigue for 4 days.  Treatment details included diphenhydramine: for 2 days, acetaminophen, dextromethorphan, and phenylephrine 1/ 2 recommended dose listed on the bottle for 3 days.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  On 9 Feb 2021 the outcome of event pain inside of left ear, fatigue for 4 days was resolved. The outcome of events extreme swelling of lymph node, swelling of neck, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite was resolving.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Hotness at the injection site; Redness at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hotness at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MAGNESIUM OXIDE (MAGNESIUM OXIDE 400), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE, Vitamin D and CETIRIZINE HYDROCHLORIDE (ZYRTEC) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the injection site). On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hotness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Hotness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and INJECTION SITE PRURITUS (Itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided by the reporter as allergy shots every 2 weeks. Treatment information was provided as Triamcinolone 0.1%.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-031240 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-031240 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Vaccination site rash, Vaccination site swelling
Clinical narrative: skin rash; Nine days after first dose rash on arm; Nine days after first dose arm swollen; Erythema; A spontaneous report was, received  from a nurse, concerning a female patient of 71 years old age, who received Moderna's Covid-19 vaccine and experienced skin rash, Nine days after first dose ash on arm, Nine days after first dose arm swollen, Erythema.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15Jan2021, prior the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 013L20A) via unknown route for COVID-19 infection prophylaxis.  On 24Jan2021, the patient experienced ongoing skin rash, Nine days after first dose ash on arm, Nine days after first dose arm swollen, Erythema. The treatment information was not reported.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, skin rash, Nine days after first dose ash on arm, Nine days after first dose arm swollen, Erythema were considered to be unknown at the time of this report.  Based on MSA comment, Erythema change listedness to Unlisted, Vaccination site swelling and Vaccination site rash change listedness to listed
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: felt cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (felt cold) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (felt cold). At the time of the report, CHILLS (felt cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid 19.  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 Tested positive for COVID 19.No laboratory details was provided.Treatment details included, Bamlanivimab was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event covid 19 was unknown at the time of the report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Nausea, Vaccination site warmth
Clinical narrative: mild nausea and weakness; mild nausea and weakness; body aches; arm of the injection site was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of the injection site was warm to touch), ASTHENIA (mild nausea and weakness), NAUSEA (mild nausea and weakness) and MYALGIA (body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm of the injection site was warm to touch). On 07-Feb-2021, the patient experienced MYALGIA (body aches). On 09-Feb-2021, the patient experienced ASTHENIA (mild nausea and weakness) and NAUSEA (mild nausea and weakness). On 06-Feb-2021, VACCINATION SITE WARMTH (arm of the injection site was warm to touch) had resolved. At the time of the report, ASTHENIA (mild nausea and weakness), NAUSEA (mild nausea and weakness) and MYALGIA (body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products were not provided.  Treatment medication were not reported.   This case was linked to MOD-2021-096674 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: updated event outcome to recovered.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore Arm; Chills; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, 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 10 Feb 2021, the patient experienced the event(s) sore arm, chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, chills was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Diarrhoea, Myalgia, Nasal congestion
Clinical narrative: Little anxious; Injection site is still inflamed; Injection site hurts; Diarrhea; Stuffy nose; Ache all over; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed), NASAL CONGESTION (Stuffy nose) and MYALGIA (Ache all over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included LABETALOL, HYDRALAZINE, TELMISARTAN, ROSUVASTATIN, LEVOTHYROXINE, FAMOTIDINE, MULTIVITAMINS & MINERALS PLUS LUTEIN, CALCIUM, PROBIOTIC 10, PARACETAMOL (TYLENOL), VITAMIN B12 [VITAMIN B12 NOS], SODIUM CHLORIDE, BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN 81) and DENOSUMAB.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NASAL CONGESTION (Stuffy nose), MYALGIA (Ache all over), CHILLS (Chills) and PYREXIA (Low grade fever). On 09-Feb-2021, the patient experienced ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed) and VACCINATION SITE PAIN (Injection site hurts). On 09-Feb-2021, DIARRHOEA (Diarrhea), NASAL CONGESTION (Stuffy nose), MYALGIA (Ache all over), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed) and VACCINATION SITE PAIN (Injection site hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . No treatment related information has been reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Little anxious; Injection site is still inflamed; Injection site hurts; Diarrhea; Stuffy nose; Ache all over; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed), NASAL CONGESTION (Stuffy nose) and MYALGIA (Ache all over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concomitant products included LABETALOL, HYDRALAZINE, TELMISARTAN, ROSUVASTATIN, LEVOTHYROXINE, FAMOTIDINE, MULTIVITAMINS & MINERALS PLUS LUTEIN, CALCIUM, PROBIOTIC 10, PARACETAMOL (TYLENOL), VITAMIN B12 [VITAMIN B12 NOS], SODIUM CHLORIDE, BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN 81) and DENOSUMAB.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NASAL CONGESTION (Stuffy nose), MYALGIA (Ache all over), CHILLS (Chills) and PYREXIA (Low grade fever). On 09-Feb-2021, the patient experienced ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed) and VACCINATION SITE PAIN (Injection site hurts). On 09-Feb-2021, DIARRHOEA (Diarrhea), NASAL CONGESTION (Stuffy nose), MYALGIA (Ache all over), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed) and VACCINATION SITE PAIN (Injection site hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . No treatment related information has been reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; A spontaneous report was received from a Consumer concerning a 43-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 4 Jan 2021, the patient experienced the event sore arm .  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, sore arm was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: General Body pain; Hot injection site; Itchy injection site; Redness at injection site; Joint ache; Headache; Nausea; Fever (101.9); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and ARTHRALGIA (Joint ache) in a 67-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.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)). On an unknown date, the patient experienced PAIN (General Body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)) outcome was unknown.            No Concomitant medication were reported.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: General Body pain; Hot injection site; Itchy injection site; Redness at injection site; Joint ache; Headache; Nausea; Fever (101.9); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and ARTHRALGIA (Joint ache) in a 67-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.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)). On an unknown date, the patient experienced PAIN (General Body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)) outcome was unknown.            No Concomitant medication were reported.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: the rash also began to spread on his arms and legs; rash on his back; rash on his head; A spontaneous report was received from a consumer concerning a 67- year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on his head, rash on his back and rash on his arms and legs.  The patient's medical history was not provided. Concomitant medications were reported as blood high pressure medicine.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event rash on his head.  On 8 Feb 2021, the patient experienced the event rash on his back.  On 9 Feb 2021, the patient experienced the event rash on his arms and legs.Now it's more visible on her back. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash on his head, rash on his back, rash on his arms and legs were unknown.  Based on comment, Rashes ( change listedness to listed and unlisted for monograph and factsheet)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Influenza like illness, Insomnia, Muscle tightness
Clinical narrative: tightness on left upper shoulder and left side of the neck; tightness on left upper shoulder and left side of the neck; felt like having the flu; WEAK; COLD; difficulty sleeping because of the pain; body aches; burning in the arm of injection; chills; A spontaneous report was received from a  43-years-old  female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  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 their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 3 Feb 2021, the patient experienced the events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  was unknown.  Based on regulatory authority comment, Myalgia and Chills (listed). Injection site pain coded Vaccination site pain
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Nasopharyngitis, Vaccination site pain
Clinical narrative: tightness on left upper shoulder and left side of the neck; tightness on left upper shoulder and left side of the neck; felt like having the flu; WEAK; COLD; difficulty sleeping because of the pain; body aches; burning in the arm of injection; chills; A spontaneous report was received from a  43-years-old  female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  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 their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 3 Feb 2021, the patient experienced the events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain.  was unknown.  Based on regulatory authority comment, Myalgia and Chills (listed). Injection site pain coded Vaccination site pain
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Peripheral swelling, Pyrexia
Clinical narrative: swelling on her arm; Chills,shivering; temp is 101; Headache; A spontaneous report was received from a  consumer concerning a 49 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling in the arm got vaccine/Peripheral swelling, chills, headaches, fever temp is 101, shivering/chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced the event(s) swelling in the arm got vaccine, chills, headaches, fever temp is 101, shivering.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swelling in the arm got vaccine, chills, headaches, fever temp is 101, shivering was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Muscle spasms
Clinical narrative: Flu like symptoms; Muscle cramps; Headache; A spontaneous report was received on 9 Feb 2021, from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, flu.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the event(s) headache, flu.  Treatment details included Tylenol, Product Product Description Product Detail Category Topic.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, flu was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pruritus
Clinical narrative: itching on legs, back, arm, and back of neck; feeling tired; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on legs, back, arm, and back of neck), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (ASPIRIN 81) and LEVOTHYROXINE for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (itching on legs, back, arm, and back of neck), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache). At the time of the report, PRURITUS (itching on legs, back, arm, and back of neck), FATIGUE (feeling tired), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: itchy and swollen around lips; itchy and swollen around lips; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy and swollen around lips) and LIP SWELLING (itchy and swollen around lips) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchy and swollen around lips) and LIP SWELLING (itchy and swollen around lips). At the time of the report, PRURITUS (itchy and swollen around lips) and LIP SWELLING (itchy and swollen around lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.   Reporter did not allow further contact