chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised; arm became red and raised where the injection was; Itchy, about a 3-inch circle where it was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm became red and raised where the injection was), VACCINATION SITE PRURITUS (Itchy, about a 3-inch circle where it was) and VACCINATION SITE SWELLING (arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became red and raised where the injection was) and VACCINATION SITE PRURITUS (Itchy, about a 3-inch circle where it was).   On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised).   At the time of the report, VACCINATION SITE ERYTHEMA (arm became red and raised where the injection was), VACCINATION SITE PRURITUS (Itchy, about a 3-inch circle where it was) and VACCINATION SITE SWELLING (arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination side effects). At the time of the report, VACCINATION COMPLICATION (vaccination side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: NNI- Non-significant follow up appended in which Email address updated.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Fatigue, Headache
Clinical narrative: Rash across my stomach that was very itchy; Stomach was bloated; Stomach was painful; Fatigue; Chills; Severe headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue) and CHILLS (Chills) in a 58-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.  On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 31-Dec-2020, the patient experienced RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Severe headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   At the time of the report, RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Severe headache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash across my stomach that was very itchy; Stomach was bloated; Stomach was painful; Fatigue; Chills; Severe headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue) and CHILLS (Chills) in a 58-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.  On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 31-Dec-2020, the patient experienced RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Severe headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   At the time of the report, RASH PRURITIC (Rash across my stomach that was very itchy), ABDOMINAL DISTENSION (Stomach was bloated), ABDOMINAL PAIN UPPER (Stomach was painful), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Severe headache) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain
Clinical narrative: lower back pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm) and BACK PAIN (lower back pain) in a 68-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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced AXILLARY PAIN (sore arm).   On 08-Feb-2021, the patient experienced BACK PAIN (lower back pain). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency and PARACETAMOL (PAIN RELIEVER) for Low back pain, at an unspecified dose and frequency.   On 03-Feb-2021, AXILLARY PAIN (sore arm) had resolved. At the time of the report, BACK PAIN (lower back pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Urticaria, Vaccination complication, Vaccination site erythema, Vaccination site warmth
Clinical narrative: broke out, 'looked scarier than what it was'; Hot feeling; redness; experienced adverse events; hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch), URTICARIA (broke out, 'looked scarier than what it was'), FEELING HOT (Hot feeling) and VACCINATION SITE ERYTHEMA (redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE ERYTHEMA (redness). On an unknown date, the patient experienced URTICARIA (broke out, 'looked scarier than what it was') and FEELING HOT (Hot feeling). At the time of the report, VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch), URTICARIA (broke out, 'looked scarier than what it was'), FEELING HOT (Hot feeling) and VACCINATION SITE ERYTHEMA (redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No Treatment details was included.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information was received on 21-May-2021, patient demographic details (sex) and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (spot has some discoloration), VACCINATION SITE INDURATION (the area is still a bit hard), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (spot has some discoloration), VACCINATION SITE INDURATION (the area is still a bit hard), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Adverse event following immunisation, at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. In January 2021, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (spot has some discoloration) and VACCINATION SITE INDURATION (the area is still a bit hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications 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 these events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer concerning a 74-year-old, female patient who experienced diarrhea and a little sore at injection site/vaccination site pain.   The patient's medical history and concomitant medications were not provided.  On 21-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their planned first dose of mRNA-1273 injection (Lot/Batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection to the upper left arm.   On 22-Jan-2021, the day after injection, the patient was a little sore at the injection site and experienced diarrhea. The soreness at the injection site lasted four to five days and stopped on 27-Jan-2021. The diarrhea persisted until  27JAN2021.  It had been 18 days since she first experienced diarrhea.  She took loperamide hydrochloride and electrolytes NOS/glucose, but had recently stopped. She was not taking any other medications. On 03-Feb-2021, she was seen by her Gastroenterologist, who sent a fecal sample for testing. The test showed no viral infection. She visited her General Practitioner on 08-Feb-2021 for bloodwork. A colonoscopy is planned at some point soon to rule out colitis.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event of diarrhea is not recovered/not resolved. The outcome for the event little sore at injection site is recovered.; Reporter'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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body ache; Fever spiked that night to 102.6; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PYREXIA (Fever spiked that night to 102.6), CHILLS (Chills) and HEADACHE (Headache) 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 was not reported .  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever spiked that night to 102.6), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever spiked that night to 102.6) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were provided as Methotryx (sp?)  an arthritis medicine. Treatment medication also include Tylenol; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever; rigors; headache; feeling tired; stomach cramps; muscle cramps; Flu like symptoms; Aches all over body; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired) and ABDOMINAL PAIN UPPER (stomach cramps) in a 65-year-old male 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.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (muscle cramps), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Aches all over body) and DIARRHOEA (Diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (muscle cramps), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Aches all over body) and DIARRHOEA (Diarrhoea) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Muscle spasms, Pain, Pyrexia
Clinical narrative: Fever; rigors; headache; feeling tired; stomach cramps; muscle cramps; Flu like symptoms; Aches all over body; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired) and ABDOMINAL PAIN UPPER (stomach cramps) in a 65-year-old male 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.  On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (muscle cramps), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Aches all over body) and DIARRHOEA (Diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.   At the time of the report, PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (muscle cramps), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Aches all over body) and DIARRHOEA (Diarrhoea) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Upper right arm arm, around the shoulder is kinda to somewhat sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Upper right arm arm, around the shoulder is kinda to somewhat sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Placebo (Got unblinded in Moderna trial.).  On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Upper right arm arm, around the shoulder is kinda to somewhat sore).   At the time of the report, VACCINATION SITE PAIN (Upper right arm arm, around the shoulder is kinda to somewhat sore) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid after getting first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for covid after getting first dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid after getting first dose). At the time of the report, COVID-19 (tested positive for covid after getting first dose) 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.   This case concerns a 60-year-old female who NS unexpected events of COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 60-year-old female who NS unexpected events of COVID-19.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Facial pain, Limb discomfort, Myalgia, Swelling face
Clinical narrative: injection site and jaw still sore; face swelling; immediate throat burning; immediate chest burning; My arm was killing me; injection arm hand turned purple/red; unbearable face pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me) and VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red) in a 54-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 Surgery (right jaw joint replacement).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me), VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red) and FACIAL PAIN (unbearable face pain). On 08-Feb-2021, the patient experienced MYALGIA (injection site and jaw still sore). The patient was treated with FENTANYL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me), VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red), FACIAL PAIN (unbearable face pain) and MYALGIA (injection site and jaw still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment- Benadryl Concomitant medication information was not reported.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site erythema
Clinical narrative: injection site and jaw still sore; face swelling; immediate throat burning; immediate chest burning; My arm was killing me; injection arm hand turned purple/red; unbearable face pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me) and VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red) in a 54-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 Surgery (right jaw joint replacement).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me), VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red) and FACIAL PAIN (unbearable face pain). On 08-Feb-2021, the patient experienced MYALGIA (injection site and jaw still sore). The patient was treated with FENTANYL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me), VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red), FACIAL PAIN (unbearable face pain) and MYALGIA (injection site and jaw still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment- Benadryl Concomitant medication information was not reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site induration
Clinical narrative: low grade fever; red patch around injection site; injection site sore; swollen at injection site; injection site feels hot; Injection site hard; itchy at injection site; hivish at injection site; Felt exhausted and fatigued; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt exhausted and fatigued). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (red patch around injection site), VACCINATION SITE PAIN (injection site sore) and VACCINATION SITE SWELLING (swollen at injection site). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) for Itchy rash, at a dose of 0.1 %; LAVENDER OIL at a dose of 1 dosage form and MELALEUCA ALTERNIFOLIA OIL (TEA TREE) for Itchy rash, at a dose of 1 dosage form. In February 2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site), FATIGUE (Felt exhausted and fatigued) and VACCINATION SITE ERYTHEMA (red patch around injection site) had resolved, VACCINATION SITE URTICARIA (hivish at injection site) and VACCINATION SITE PAIN (injection site sore) had not resolved. At the time of the report, PYREXIA (low grade fever) and VACCINATION SITE SWELLING (swollen at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer stated the events subsided within a few days.   This case was linked to MOD-2021-124421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 Added new event.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: low grade fever; red patch around injection site; injection site sore; swollen at injection site; injection site feels hot; Injection site hard; itchy at injection site; hivish at injection site; Felt exhausted and fatigued; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt exhausted and fatigued). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (red patch around injection site), VACCINATION SITE PAIN (injection site sore) and VACCINATION SITE SWELLING (swollen at injection site). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) for Itchy rash, at a dose of 0.1 %; LAVENDER OIL at a dose of 1 dosage form and MELALEUCA ALTERNIFOLIA OIL (TEA TREE) for Itchy rash, at a dose of 1 dosage form. In February 2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site), FATIGUE (Felt exhausted and fatigued) and VACCINATION SITE ERYTHEMA (red patch around injection site) had resolved, VACCINATION SITE URTICARIA (hivish at injection site) and VACCINATION SITE PAIN (injection site sore) had not resolved. At the time of the report, PYREXIA (low grade fever) and VACCINATION SITE SWELLING (swollen at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer stated the events subsided within a few days.   This case was linked to MOD-2021-124421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 Added new event.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm in elbow area was sore and slightly swollen; Pain in left elbow started weeks after first shot; Sore injection site; Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth; minor numbness at the perimeter of her mouth; arm was still sore; This spontaneous case was reported by a physician assistant and describes the occurrence of PARAESTHESIA (Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth), HYPOAESTHESIA (minor numbness at the perimeter of her mouth), AXILLARY PAIN (arm was still sore), JOINT SWELLING (Left arm in elbow area was sore and slightly swollen) and VACCINATION SITE PAIN (Sore injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE and LOSARTAN POTASSIUM for Blood pressure, ROSUVASTATIN CALCIUM.   On 22-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth), HYPOAESTHESIA (minor numbness at the perimeter of her mouth) and VACCINATION SITE PAIN (Sore injection site). 22-Feb-2021, the patient experienced AXILLARY PAIN (arm was still sore). On an unknown date, the patient experienced JOINT SWELLING (Left arm in elbow area was sore and slightly swollen) and ARTHRALGIA (Pain in left elbow started weeks after first shot). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth), HYPOAESTHESIA (minor numbness at the perimeter of her mouth) and AXILLARY PAIN (arm was still sore) was resolving, JOINT SWELLING (Left arm in elbow area was sore and slightly swollen) and VACCINATION SITE PAIN (Sore injection site) outcome was unknown and ARTHRALGIA (Pain in left elbow started weeks after first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It is reported that patient is currently consuming blood pressure pills.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-Jul-2021, new events arthralgia and joint swelling were added and concomitant details were updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red mark at her injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark at her injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medial history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red mark at her injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red mark at her injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Reaction to the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Sulfa allergy) since an unknown date.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Reaction to the vaccine). At the time of the report, ADVERSE EVENT (Reaction to the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: I am also allergic; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I am also allergic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ADRENALINE [EPINEPHRINE] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (I am also allergic). At the time of the report, ALLERGY TO VACCINE (I am also allergic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            The patient received second dose of vaccine and was all fine and do not have any further Adverse event to report.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102M20A) for COVID-19 vaccination.     The patient's past medical history included Convalescent plasma transfusion in December 2020.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 02-Jan-2021, CHILLS (Chills) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PRURITUS (INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED) had resolved. Not Provided      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.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Reaction; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 UNEVALUABLE EVENT (Reaction). At the time of the report, UNEVALUABLE EVENT (Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site macule, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy at  injection site; Tender at vaccination site; Large circular blotch in the skin; Little swollen at vaccination site; Arm hurt; Redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tender at vaccination site), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE PRURITUS (Itchy at  injection site) in a 41-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.     Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tender at vaccination site), VACCINATION SITE MACULE (Large circular blotch in the skin) and VACCINATION SITE SWELLING (Little swollen at vaccination site). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at  injection site). On 22-Jan-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, VACCINATION SITE PAIN (Tender at vaccination site) had resolved, VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itchy at  injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included lotion application on the affected area.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Itchy at  injection site; Tender at vaccination site; Large circular blotch in the skin; Little swollen at vaccination site; Arm hurt; Redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tender at vaccination site), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE PRURITUS (Itchy at  injection site) in a 41-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.     Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tender at vaccination site), VACCINATION SITE MACULE (Large circular blotch in the skin) and VACCINATION SITE SWELLING (Little swollen at vaccination site). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at  injection site). On 22-Jan-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, VACCINATION SITE PAIN (Tender at vaccination site) had resolved, VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itchy at  injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included lotion application on the affected area.