chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site kind of red; injection site kind of swollen; slight pain at the injection site when she touches it; soreness at the injection site/a little pain at the injection site; A spontaneous report was received from a consumer of 75-years-old  patient concerning self  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at the injection site, a little pain at the injection site, injection site kind of red, injection site kind of swollen, slight pain at the injection site when she touches it.  The patient's medical history was not provided. Concomitant medications included blood pressure medication and vitamins. On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and unknown anatomical location for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events soreness at the injection site and a little pain at the injection site .  On 17 Feb 2021, the patient experienced the events , injection site kind of red, injection site kind of swollen, slight pain at the injection site when she touches it. Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events soreness at the injection site and  a little pain at the injection site was considered resolved on 5 Feb 2021. The outcome of event(s),  injection site kind of red, injection site kind of swollen, slight pain at the injection site when she touches it was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Bruise around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise around the injection site) in a 66-year-old female 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 prior medical history was reported). Concomitant products included CENTRUM SILVER +50, VITAMIN 15, CALCIUM and FISH OIL for an unknown indication.    On 23-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 INJECTION SITE BRUISING (Bruise around the injection site). On 31-Jan-2021, INJECTION SITE BRUISING (Bruise around the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were multivitamin with minerals, vitamin, calcium, supplement (fish oil) of drug use for unknown indication. No treatment information provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart Rate Increased (Fluctuating Max 150 BPM); A spontaneous report was received from a 53-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart rate increased (fluctuating max 150 bpm).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) 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: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event heart rate increased (fluctuating max 150 bpm) .   Treatment details included Heart Monitor for the two weeks.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, heart rate increased (fluctuating max 150 bpm) was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: side effects; A spontaneous report was received from a consumer concerning a 90-years-old female elder patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events side effects.  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 their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown  The outcome of event(s), side effects,  was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site warmth, Pruritus
Clinical narrative: still red; big, red bull's-eye; flaming red; hot; very very itchy; low grade fever; giant circle rash; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events big, red bull's-eye, flaming red, hot, really big, huge, very very itchy, low grade fever, giant circle rash, still red.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) big. red bull's-eye, flaming red, hot, really big, huge, very very itchy, low grade fever, giant circle rash, still red.  Treatment for the event, included Claritin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), big, red bull's-eye,flaming red,hot,really big,huge,very very itchy,low grade fever,giant circle rash,still red was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: still red; big, red bull's-eye; flaming red; hot; very very itchy; low grade fever; giant circle rash; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events big, red bull's-eye, flaming red, hot, really big, huge, very very itchy, low grade fever, giant circle rash, still red.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) big. red bull's-eye, flaming red, hot, really big, huge, very very itchy, low grade fever, giant circle rash, still red.  Treatment for the event, included Claritin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), big, red bull's-eye,flaming red,hot,really big,huge,very very itchy,low grade fever,giant circle rash,still red was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site irritation, Vaccination site pain
Clinical narrative: felt like bee sting on injection site; red patch at injection site; uncomfortable at injection site; irritating but not itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (uncomfortable at injection site), VACCINATION SITE IRRITATION (irritating but not itchy), VACCINATION SITE PAIN (felt like bee sting on injection site) and VACCINATION SITE ERYTHEMA (red patch at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (uncomfortable at injection site), VACCINATION SITE IRRITATION (irritating but not itchy) and VACCINATION SITE ERYTHEMA (red patch at injection site). On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (felt like bee sting on injection site). On 17-Feb-2021, VACCINATION SITE PAIN (felt like bee sting on injection site) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (uncomfortable at injection site), VACCINATION SITE IRRITATION (irritating but not itchy) and VACCINATION SITE ERYTHEMA (red patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23-Jul-2021 and contains no new information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pruritus, Rash
Clinical narrative: severe rash; ITCH; BIG RED WALT; It is very hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (severe rash), PRURITUS (ITCH), INJECTION SITE ERYTHEMA (BIG RED WALT) and INJECTION SITE WARMTH (It is very hot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced RASH (severe rash), PRURITUS (ITCH), INJECTION SITE ERYTHEMA (BIG RED WALT) and INJECTION SITE WARMTH (It is very hot). At the time of the report, RASH (severe rash), PRURITUS (ITCH), INJECTION SITE ERYTHEMA (BIG RED WALT) and INJECTION SITE WARMTH (It is very hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No concomitant drugs are provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Inflamed; Swollen and red where I got shot, closer to my elbow swollen like baseball; Swollen and red where I got shot; Very sore; My face felt like I had couple of shots of Novocain; My cheeks and teeth felt very numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (My face felt like I had couple of shots of Novocain), HYPOAESTHESIA (My cheeks and teeth felt very numb), VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball) and VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included ANASTROZOLE (ARIMIDEX) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SWELLING FACE (My face felt like I had couple of shots of Novocain) and HYPOAESTHESIA (My cheeks and teeth felt very numb). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball), VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) and VACCINATION SITE PAIN (Very sore). On 15-Feb-2021, SWELLING FACE (My face felt like I had couple of shots of Novocain) and HYPOAESTHESIA (My cheeks and teeth felt very numb) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball), VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) and VACCINATION SITE PAIN (Very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen.  Concomitant drugs includes Arimidex   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Inflamed; Swollen and red where I got shot, closer to my elbow swollen like baseball; Swollen and red where I got shot; Very sore; My face felt like I had couple of shots of Novocain; My cheeks and teeth felt very numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (My face felt like I had couple of shots of Novocain), HYPOAESTHESIA (My cheeks and teeth felt very numb), VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball) and VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included ANASTROZOLE (ARIMIDEX) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SWELLING FACE (My face felt like I had couple of shots of Novocain) and HYPOAESTHESIA (My cheeks and teeth felt very numb). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball), VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) and VACCINATION SITE PAIN (Very sore). On 15-Feb-2021, SWELLING FACE (My face felt like I had couple of shots of Novocain) and HYPOAESTHESIA (My cheeks and teeth felt very numb) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball), VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) and VACCINATION SITE PAIN (Very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen.  Concomitant drugs includes Arimidex   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Pruritus, Pyrexia, Rash
Clinical narrative: Bright red oval rash; Tender; Itchy; Constant nagging pain; Uncomfortable; Very irritated; Rash that was painful; Fever; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bright red oval rash/rash erythematous, rash that was painful/rash, tender/tenderness, itchy/pruritus, and uncomfortable/discomfort, fever, a constant nagging pain/pain and was very irritated/skin irritation.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Feb 2021, patient experienced bright red oval rash that was painful, tender, itchy, and uncomfortable, fever, constant nagging pain and was very irritated.  Lab details were not provided by the reporter.  Treatment for the events included alternated warm and cold compress.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, bright red oval rash, rash that was painful, tender, itchy, uncomfortable, constant nagging pain and was very irritated was recovered on 12 Feb 2021. The outcome of the event, fever was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin irritation, Tenderness
Clinical narrative: Bright red oval rash; Tender; Itchy; Constant nagging pain; Uncomfortable; Very irritated; Rash that was painful; Fever; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bright red oval rash/rash erythematous, rash that was painful/rash, tender/tenderness, itchy/pruritus, and uncomfortable/discomfort, fever, a constant nagging pain/pain and was very irritated/skin irritation.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Feb 2021, patient experienced bright red oval rash that was painful, tender, itchy, and uncomfortable, fever, constant nagging pain and was very irritated.  Lab details were not provided by the reporter.  Treatment for the events included alternated warm and cold compress.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, bright red oval rash, rash that was painful, tender, itchy, uncomfortable, constant nagging pain and was very irritated was recovered on 12 Feb 2021. The outcome of the event, fever was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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 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 VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Covid arm- red swelling on the injection site; Covid arm- red swelling on the injection; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Tiredness), INJECTION SITE SWELLING (Covid arm- red swelling on the injection site) and INJECTION SITE ERYTHEMA (Covid arm- red swelling on the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). On an unknown date, the patient experienced INJECTION SITE SWELLING (Covid arm- red swelling on the injection site) and INJECTION SITE ERYTHEMA (Covid arm- red swelling on the injection). At the time of the report, CHILLS (Chills), FATIGUE (Tiredness), INJECTION SITE SWELLING (Covid arm- red swelling on the injection site) and INJECTION SITE ERYTHEMA (Covid arm- red swelling on the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was provided as Tylenol. Relevant concomitant medications were not reported.      Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Pruritus, Throat tightness
Clinical narrative: itch between the fingers of the arm where the vaccine was received,and left side of faceand legs; arm started bleeding when she was given the vaccine; her throat closing up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch between the fingers of the arm where the vaccine was received,and left side of faceand legs), INJECTION SITE HAEMORRHAGE (arm started bleeding when she was given the vaccine) and THROAT TIGHTNESS (her throat closing up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (itch between the fingers of the arm where the vaccine was received,and left side of faceand legs), INJECTION SITE HAEMORRHAGE (arm started bleeding when she was given the vaccine) and THROAT TIGHTNESS (her throat closing up). At the time of the report, PRURITUS (itch between the fingers of the arm where the vaccine was received,and left side of faceand legs), INJECTION SITE HAEMORRHAGE (arm started bleeding when she was given the vaccine) and THROAT TIGHTNESS (her throat closing up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was provided as clearetan (allergy pills).     Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Myalgia, Pruritus, Rash
Clinical narrative: palms are red and swollen; palms are red and swollen; she woke up at 1am because she could not stop scratching her hands; rash inside of her elbows and knees/ patches of rash everywhere; not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath; rash/ hives terribly itchy; lips swollen and look like she had Botox but she does not do that; pain in the muscle where she got the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy), LIP SWELLING (lips swollen and look like she had Botox but she does not do that), ERYTHEMA (palms are red and swollen) and SWELLING (palms are red and swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, DULOXETINE, NORTRIPTYLINE and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (pain in the muscle where she got the shot). On 16-Feb-2021, the patient experienced URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy) and LIP SWELLING (lips swollen and look like she had Botox but she does not do that). On 17-Feb-2021, the patient experienced ERYTHEMA (palms are red and swollen), SWELLING (palms are red and swollen), PRURITUS (she woke up at 1am because she could not stop scratching her hands) and RASH (rash inside of her elbows and knees/ patches of rash everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 12-Feb-2021, MYALGIA (pain in the muscle where she got the shot) had resolved. At the time of the report, URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy), LIP SWELLING (lips swollen and look like she had Botox but she does not do that), ERYTHEMA (palms are red and swollen), SWELLING (palms are red and swollen), PRURITUS (she woke up at 1am because she could not stop scratching her hands) and RASH (rash inside of her elbows and knees/ patches of rash everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: palms are red and swollen; palms are red and swollen; she woke up at 1am because she could not stop scratching her hands; rash inside of her elbows and knees/ patches of rash everywhere; not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath; rash/ hives terribly itchy; lips swollen and look like she had Botox but she does not do that; pain in the muscle where she got the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy), LIP SWELLING (lips swollen and look like she had Botox but she does not do that), ERYTHEMA (palms are red and swollen) and SWELLING (palms are red and swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, DULOXETINE, NORTRIPTYLINE and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (pain in the muscle where she got the shot). On 16-Feb-2021, the patient experienced URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy) and LIP SWELLING (lips swollen and look like she had Botox but she does not do that). On 17-Feb-2021, the patient experienced ERYTHEMA (palms are red and swollen), SWELLING (palms are red and swollen), PRURITUS (she woke up at 1am because she could not stop scratching her hands) and RASH (rash inside of her elbows and knees/ patches of rash everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 12-Feb-2021, MYALGIA (pain in the muscle where she got the shot) had resolved. At the time of the report, URTICARIA (not just a rash but hives in her scalp, head, ears, earlobes, armpits and bellow and underneath), PRURITUS (rash/ hives terribly itchy), LIP SWELLING (lips swollen and look like she had Botox but she does not do that), ERYTHEMA (palms are red and swollen), SWELLING (palms are red and swollen), PRURITUS (she woke up at 1am because she could not stop scratching her hands) and RASH (rash inside of her elbows and knees/ patches of rash everywhere) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral, Pain, Vomiting
Clinical narrative: stomach flu; cannot stop throwing up; little achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little achy), GASTROENTERITIS VIRAL (stomach flu) and VOMITING (cannot stop throwing up) 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 reported medical history).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (little achy) and VOMITING (cannot stop throwing up). On an unknown date, the patient experienced GASTROENTERITIS VIRAL (stomach flu). On 16-Feb-2021, PAIN (little achy) and VOMITING (cannot stop throwing up) had resolved. At the time of the report, GASTROENTERITIS VIRAL (stomach flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Lymphadenopathy
Clinical narrative: lymph nodes in her neck was swollen with pain; lymph nodes was swollen under her arm with pain; redness around the injection site; swelling at the injection site; itchiness around the injection site; rash at the injection site; pain in the injection site; A spontaneous report was received from a consumer concerning a 38-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- pain in the injection site, lymph nodes was swollen under her arm with pain, lymph nodes in her neck was swollen with pain, redness around the injection site, swelling at the injection site, rash at the injection site, itchiness around the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced pain, redness, swelling,rash and itchiness at the injection site . On 9 Feb 2021, the lymph nodes was swollen under her arm with pain . On 10 Feb 2021,  lymph nodes in her neck was swollen with pain.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- pain, redness, swelling,rash and itchiness at the injection site , the lymph nodes was swollen under her arm with pain, lymph nodes in her neck was swollen with pain- was considered to be unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lymph nodes in her neck was swollen with pain; lymph nodes was swollen under her arm with pain; redness around the injection site; swelling at the injection site; itchiness around the injection site; rash at the injection site; pain in the injection site; A spontaneous report was received from a consumer concerning a 38-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- pain in the injection site, lymph nodes was swollen under her arm with pain, lymph nodes in her neck was swollen with pain, redness around the injection site, swelling at the injection site, rash at the injection site, itchiness around the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced pain, redness, swelling,rash and itchiness at the injection site . On 9 Feb 2021, the lymph nodes was swollen under her arm with pain . On 10 Feb 2021,  lymph nodes in her neck was swollen with pain.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events- pain, redness, swelling,rash and itchiness at the injection site , the lymph nodes was swollen under her arm with pain, lymph nodes in her neck was swollen with pain- was considered to be unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body ache/body pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache/body pain) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 17-Feb-2021, the patient experienced PAIN (body ache/body pain) and HEADACHE (headache). At the time of the report, PAIN (body ache/body pain) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: 3 by 3 inches of warmth around the injection site; 3 by 3 inches of redness around the injection site; 3 by 3 inches of rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (3 by 3 inches of warmth around the injection site), VACCINATION SITE ERYTHEMA (3 by 3 inches of redness around the injection site) and VACCINATION SITE RASH (3 by 3 inches of rash around the injection site) 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 reported medical history).    On 29-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 VACCINATION SITE WARMTH (3 by 3 inches of warmth around the injection site), VACCINATION SITE ERYTHEMA (3 by 3 inches of redness around the injection site) and VACCINATION SITE RASH (3 by 3 inches of rash around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (3 by 3 inches of warmth around the injection site), VACCINATION SITE ERYTHEMA (3 by 3 inches of redness around the injection site) and VACCINATION SITE RASH (3 by 3 inches of rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were not reported.  Treatment details included Tylenol and Benadryl cream and also antibiotic.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: sore arm at the injection site; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) and FATIGUE (extreme fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site) and FATIGUE (extreme fatigue). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00LEZ0A) for COVID-19 vaccination.     The patient's past medical history included Ache NOS and Pain. Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Pain, MOMETASONE FUROATE (NASONEX), VITAMIN B NOS, RISPERIDONE (RISPERDAL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (aches and pain). At the time of the report, PAIN (aches and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site warmth, Paraesthesia
Clinical narrative: heat (L) arm; tingling (L) arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (heat (L) arm), PARAESTHESIA (tingling (L) arm) and FATIGUE (fatigue) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported). Concomitant products included Ibuprofen for an unknown indication.    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 INJECTION SITE WARMTH (heat (L) arm), PARAESTHESIA (tingling (L) arm) and FATIGUE (fatigue). At the time of the report, INJECTION SITE WARMTH (heat (L) arm), PARAESTHESIA (tingling (L) arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include ibuprofen 2 doses.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: m my arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (m my arm is sore at the injection site) in a 66-year-old male 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 (No adverse event reported).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PAIN (m my arm is sore at the injection site). At the time of the report, INJECTION SITE PAIN (m my arm is sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: Headache; my blood pressure spiked very high 169/81; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (my blood pressure spiked very high 169/81) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (statins) and Allergy to antibiotic (Clindamycin). Concomitant products included LOSARTAN for Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (my blood pressure spiked very high 169/81). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, BLOOD PRESSURE INCREASED (my blood pressure spiked very high 169/81) and HEADACHE (Headache) had resolved. Not provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 169/81 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    This case was linked to MOD-2021-261529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received Contains significant information: Added medical history, Added concomitant medication, updated event onset date and outcome of the event  were updated.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache) and CHILLS (chills). At the time of the report, HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.   Treatment information was not provided.    Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Myalgia, Rash, Urticaria
Clinical narrative: Now it's all over my neck and body and chest area; rash all over your body, with hives and redness; rash all over your body, with hives and redness; rash all over your body, with hives and redness; Fatigue; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle pain), RASH (rash all over your body, with hives and redness), URTICARIA (rash all over your body, with hives and redness) and ERYTHEMA (rash all over your body, with hives and redness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Muscle pain). On 14-Feb-2021, the patient experienced RASH (rash all over your body, with hives and redness), URTICARIA (rash all over your body, with hives and redness) and ERYTHEMA (rash all over your body, with hives and redness). On 15-Feb-2021, the patient experienced RASH (Now it's all over my neck and body and chest area). At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle pain) and RASH (Now it's all over my neck and body and chest area) outcome was unknown and RASH (rash all over your body, with hives and redness), URTICARIA (rash all over your body, with hives and redness) and ERYTHEMA (rash all over your body, with hives and redness) had resolved.      Treatment information included Benadryl (diphenhydramine HCL).
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: sore lump in my throat; a cough I can't cough up; a slight headache; and a slight fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore lump in my throat), COUGH (a cough I can't cough up), HEADACHE (a slight headache) and PYREXIA (and a slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore lump in my throat), COUGH (a cough I can't cough up), HEADACHE (a slight headache) and PYREXIA (and a slight fever). At the time of the report, OROPHARYNGEAL PAIN (sore lump in my throat), COUGH (a cough I can't cough up), HEADACHE (a slight headache) and PYREXIA (and a slight fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site rash
Clinical narrative: rashes at the area of the injection; itchiness at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rashes at the area of the injection) and INJECTION SITE PRURITUS (itchiness at the area of the injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042620A and 030M20A) for COVID-19 vaccination.     No medical history reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE RASH (rashes at the area of the injection) and INJECTION SITE PRURITUS (itchiness at the area of the injection). At the time of the report, VACCINATION SITE RASH (rashes at the area of the injection) and INJECTION SITE PRURITUS (itchiness at the area of the injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not specified.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: she was very dizzy; the room was spinning for 2 hours; headaches for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches for 2 days), DIZZINESS (she was very dizzy) and VERTIGO (the room was spinning for 2 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM 600 MG WITH VITAMIN D), DOCUSATE SODIUM, LORATADINE, VITAMIN D3, Vitamin C, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and ESTROGEN NOS for an unknown indication.   On 11-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 HEADACHE (headaches for 2 days). On 14-Feb-2021, the patient experienced DIZZINESS (she was very dizzy) and VERTIGO (the room was spinning for 2 hours). On 13-Feb-2021, HEADACHE (headaches for 2 days) had resolved. On 14-Feb-2021, DIZZINESS (she was very dizzy) and VERTIGO (the room was spinning for 2 hours) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment was provided.