chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Urinary tract infection, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine; Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-; Arm turned bright red; Arm was swollen; Arm was kind of itchy; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine), ABDOMINAL PAIN LOWER (Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-), VACCINATION SITE ERYTHEMA (Arm turned bright red), VACCINATION SITE PRURITUS (Arm was kind of itchy) and VACCINATION SITE SWELLING (Arm was swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE and ANASTROZOLE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Arm was kind of itchy). On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm turned bright red) and VACCINATION SITE SWELLING (Arm was swollen). On an unknown date, the patient experienced URINARY TRACT INFECTION (Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine) and ABDOMINAL PAIN LOWER (Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-). At the time of the report, URINARY TRACT INFECTION (Suspected UTI (urinary tract infection) after receiving the Moderna COVID-19 Vaccine), ABDOMINAL PAIN LOWER (Pain at "the lower stomach , probably where is the bladder" after receiving the Moderna COVID-), VACCINATION SITE ERYTHEMA (Arm turned bright red), VACCINATION SITE PRURITUS (Arm was kind of itchy) and VACCINATION SITE SWELLING (Arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Email ID added, date of birth updated, concomitant medications added and newevents added
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I had some swelling in my lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I had some swelling in my lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (I had some swelling in my lymph nodes). At the time of the report, LYMPHADENOPATHY (I had some swelling in my lymph nodes) 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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pruritus, Injection site rash, Pain in extremity, Rash macular
Clinical narrative: developed rash on the injection site; more than a rash it was a big red blotch; started itching on the injection site but that there was nothing there; arm and shoulder pain , minor; arm and shoulder pain , minor; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm and shoulder pain , minor), ARTHRALGIA (arm and shoulder pain , minor), INJECTION SITE PRURITUS (started itching on the injection site but that there was nothing there), INJECTION SITE RASH (developed rash on the injection site) and RASH MACULAR (more than a rash it was a big red blotch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm and shoulder pain , minor) and ARTHRALGIA (arm and shoulder pain , minor). On 29-Jan-2021, the patient experienced INJECTION SITE PRURITUS (started itching on the injection site but that there was nothing there). On 31-Jan-2021, the patient experienced INJECTION SITE RASH (developed rash on the injection site) and RASH MACULAR (more than a rash it was a big red blotch). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm and shoulder pain , minor), ARTHRALGIA (arm and shoulder pain , minor), INJECTION SITE PRURITUS (started itching on the injection site but that there was nothing there), INJECTION SITE RASH (developed rash on the injection site) and RASH MACULAR (more than a rash it was a big red blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Soreness; Swelling; Red; Itchy; A spontaneous report  was received on 1 Feb 2021, from a consumer concerning a 44-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, swelling, red, itchy, swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Soreness, Swelling, Red, Itchy, Swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), soreness, swelling, red, itchy, swollen was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain on right arm; Pain on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right arm) and VACCINATION SITE PAIN (Pain on left arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement and Pacemaker insertion (cardiac). Concurrent medical conditions included Sulfonamide allergy (Allergies to Sulfas). Concomitant products included METFORMIN, APIXABAN (ELIQUIS) and OLOPATADINE HYDROCHLORIDE (LOPADINE) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on right arm) and VACCINATION SITE PAIN (Pain on left arm). At the time of the report, PAIN IN EXTREMITY (Pain on right arm) and VACCINATION SITE PAIN (Pain on left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: outcome of the events updated to resolved.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Fatigue
Clinical narrative: no energy/weakness; upset stomach; chills; headache; body ache; fatigue; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: no energy/weakness; upset stomach; chills; headache; body ache; fatigue; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache) and MYALGIA (body ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-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 ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain). At the time of the report, ASTHENIA (no energy/weakness), ABDOMINAL DISCOMFORT (upset stomach), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache), FATIGUE (fatigue), NAUSEA (nausea) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Pruritus
Clinical narrative: Still pink; Slightly Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOSENSITIVITY REACTION (Still pink) and PRURITUS (Slightly Itchy) 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 adverse event reported).    On 16-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 PHOTOSENSITIVITY REACTION (Still pink) and PRURITUS (Slightly Itchy). At the time of the report, PHOTOSENSITIVITY REACTION (Still pink) and PRURITUS (Slightly Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm is still sore from the first dose; A spontaneous report  was received from a Healthcare Professional concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm is still sore from the first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced the events right arm is sore.  Treatment details included paracetamol or ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events right arm is still sore from the first dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Achiness; Small fever; A spontaneous report was received from a Consumer concerning a 67-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced achiness and small fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events achiness and small fever.Treatment details included Advil.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) achiness and small fever were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: Severe reaction; A spontaneous report was received from a Consumer concerning a unknown age and gender of patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced severe reaction.  Treatment details included unknown  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of severe reaction was not reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Achlorhydria, Chills, Cough, Decreased appetite, Headache
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite), CHILLS (Chills), ACHLORHYDRIA (Achy) and PAIN IN EXTREMITY (Arm has been a little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 relevant medical history). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite) and CHILLS (Chills). On 01-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ACHLORHYDRIA (Achy) and PAIN IN EXTREMITY (Arm has been a little sore). At the time of the report, COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite), CHILLS (Chills), ACHLORHYDRIA (Achy), PAIN IN EXTREMITY (Arm has been a little sore) and HEADACHE (Headache) 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. When agent asked for the lot number she provided both numbers as listed 011J20A and 012M20A. She thought the first one may have been marked out. Treatment drug used is ibuprofen.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite), CHILLS (Chills), ACHLORHYDRIA (Achy) and PAIN IN EXTREMITY (Arm has been a little sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 relevant medical history). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite) and CHILLS (Chills). On 01-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ACHLORHYDRIA (Achy) and PAIN IN EXTREMITY (Arm has been a little sore). At the time of the report, COUGH (Coughing (dry cough)), DECREASED APPETITE (Lost my appetite), CHILLS (Chills), ACHLORHYDRIA (Achy), PAIN IN EXTREMITY (Arm has been a little sore) and HEADACHE (Headache) 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. When agent asked for the lot number she provided both numbers as listed 011J20A and 012M20A. She thought the first one may have been marked out. Treatment drug used is ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: back discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (back discomfort) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (back discomfort). At the time of the report, MUSCULOSKELETAL DISCOMFORT (back discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.   She said her friend got the second shot a couple of weeks ago and can't walk. She said her friend tried to call Moderna but hasn't received a call back.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: He was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (He was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced MYALGIA (He was sore). At the time of the report, MYALGIA (He was sore) had resolved. 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever of 100 F; Horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100 F) and HEADACHE (Horrible headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, High cholesterol, Blood pressure high and Myasthenia gravis. Concomitant products included OLMESARTAN for Blood pressure high, METFORMIN and GLYBURIDE for Diabetes, ATORVASTATIN for High cholesterol, PYRIDOSTIGMINE for Myasthenia gravis.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 01-Feb-2021, the patient experienced PYREXIA (Fever of 100 F) and HEADACHE (Horrible headache). At the time of the report, PYREXIA (Fever of 100 F) and HEADACHE (Horrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    The daughter reported the events on behalf of her mother. Treatment medication recommended by her HCP was Advil (ibuprofen). No known medication allergies reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Palpitations
Clinical narrative: swollen again; hot; red; itchy; round; 3.5-inch circular rash; fever; palpitations; swelled up; got a little red; A spontaneous report  was received from a Consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelled up, got a little red, swollen again, hot, itchy, round, 3.5-inch circular rash, fever, palpitations.  The patient's medical history include asthma and diabetes. Concomitant medications reported were inhaler, metformin for use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events swelled up. got a little red. On 29 Jan 2021, the patient experienced the events swollen again. hot, itchy, round, 3.5-inch circular rash, fever, palpitations.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, swelled up, On an unknown date the outcome of events, got a little red, On an unknown date the outcome of events, swollen again, On an unknown date the outcome of events, hot, On an unknown date the outcome of events, itchy, On an unknown date the outcome of events, round, On an unknown date the outcome of events, 3.5-inch circular rash, On an unknown date the outcome of events, fever, On an unknown date the outcome of events, palpitations was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: swollen again; hot; red; itchy; round; 3.5-inch circular rash; fever; palpitations; swelled up; got a little red; A spontaneous report  was received from a Consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelled up, got a little red, swollen again, hot, itchy, round, 3.5-inch circular rash, fever, palpitations.  The patient's medical history include asthma and diabetes. Concomitant medications reported were inhaler, metformin for use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experienced the events swelled up. got a little red. On 29 Jan 2021, the patient experienced the events swollen again. hot, itchy, round, 3.5-inch circular rash, fever, palpitations.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, swelled up, On an unknown date the outcome of events, got a little red, On an unknown date the outcome of events, swollen again, On an unknown date the outcome of events, hot, On an unknown date the outcome of events, itchy, On an unknown date the outcome of events, round, On an unknown date the outcome of events, 3.5-inch circular rash, On an unknown date the outcome of events, fever, On an unknown date the outcome of events, palpitations was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: tongue was swollen; swollen lips; hives; palm of her hands were itching; red circle on both of her armpit; Case reference number MOD-2021-019368 is a spontaneous case report sent by a Other Health Professional on 31-JAN-2021 , which refers to a Female aged 77 Years .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19. Some    later,  the patient developed tongue was swollen. Over a period of the next  days, the patient also developed swollen lips,hives,palm of her hands were itching,red circle on both of her armpit. Relevant laboratory results included   and relevant physical signs  The patient experienced the following serious criteria:. The eventual diagnosis made on was Swollen tongue . .  The patient was treated for the event. An autopsy was performed on  . In their opinion, other possible etiological factors included   and the patients age/ history or other factors .    The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.   Based on comment, causality assessment is missing, Possibly Related to all events
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itch in the Injection site (IS); burning IS; Redness IS; Hardness IS; Sore Arm; A spontaneous report was received from a Consumer concerning a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itch in the injection site (is), burning is, redness is, hardness is, sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 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 for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the events itch in the injection site (is). burning is, redness is, hardness is, sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, itch in the injection site (is), On an unknown date the outcome of events, burning is, On an unknown date the outcome of events, redness is, On an unknown date the outcome of events, hardness is, On an unknown date the outcome of events, sore arm was not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Malaise, Pyrexia
Clinical narrative: dont feel well; fever; CHILLS; back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), MALAISE (dont feel well), PYREXIA (fever) and CHILLS (CHILLS) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Chronic sinusitis. Concomitant products included AZELASTINE for Chronic sinusitis.    On 05-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 BACK PAIN (back pain). On 01-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (CHILLS). On 02-Feb-2021, the patient experienced MALAISE (dont feel well). On 01-Feb-2021, CHILLS (CHILLS) had resolved. On 02-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, BACK PAIN (back pain) and MALAISE (dont feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient uses topical steroid spray for chronic sinusitis No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular, Type IV hypersensitivity reaction, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm broke out with little bumps; Arm was swollen; Delated cutaneous sensitivity; Arm was itching; Sore arm; A spontaneous report  was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, arm itchiness, arm broke out with little bumps, arm was swollen and delated cutaneous sensitivity.  The patient's medical history was not provided. Concomitant medications reported were insulin.  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: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Jan-2021, the patient experienced the events sore arm. On 26-Jan-2021, the patient experienced the events arm itchiness.  On 27-Jan-2021, the patient experienced the events arm broke out with little bumps, arm was swollen and delated cutaneous sensitivity.  Treatment details included hydrocortisone  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm, arm itchiness, arm broke out with little bumps, arm was swollen and delated cutaneous sensitivity, was not reported.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: AE from 1st dose; A spontaneous report was received from a consumer concerning an unspecified patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse event.  The patient's medical history, was not provided by the reporter. No concomitant medications reported.   On 12 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced some adverse events.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the adverse event were unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Injection site swelling, Injection site warmth
Clinical narrative: left me tired; Got a red rash; Hot to touch; The injection site swelled up; Was bright red; fever of 99.9°F for 24 hrs; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), INJECTION SITE SWELLING (The injection site swelled up), ERYTHEMA (Was bright red), PYREXIA (fever of 99.9°F for 24 hrs) and RASH (Got a red rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     I had no allergic reaction to any inoculations ever//form wont let me ok NO  on history march through April ran low grade fever occasionally,, , after taking my temp every other all of 2020...none in may.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for Postnasal drip, LOVASTATIN, OMEPRAZOLE and VITAMINS NOS for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 25-Jan-2021, the patient experienced INJECTION SITE SWELLING (The injection site swelled up), ERYTHEMA (Was bright red) and PYREXIA (fever of 99.9°F for 24 hrs). On 29-Jan-2021, the patient experienced RASH (Got a red rash) and INJECTION SITE WARMTH (Hot to touch). On an unknown date, the patient experienced FATIGUE (left me tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore), INJECTION SITE SWELLING (The injection site swelled up), ERYTHEMA (Was bright red), PYREXIA (fever of 99.9°F for 24 hrs), RASH (Got a red rash), INJECTION SITE WARMTH (Hot to touch) and FATIGUE (left me tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99.9°f (High) fever of 99.9°F for 24 hrs. On 29-Jan-2021, Body temperature: 98.3°f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: I iced my arm 16-01-2021:swolled red upper arm fever for 4 days   1 wk later fever for 2 days    all fever not above 100 13-02-2021 swollen red hard at injection site rash low grade fever   for 4 days I have described everything in the form, fever reaction left me tired  did call my doctor was told to report to moderna  which I did, so it should be on file   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: VAERS form is appended: patient states : fever reaction left me tired. Second dose information ,concomitants updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: left me tired; Got a red rash; Hot to touch; The injection site swelled up; Was bright red; fever of 99.9°F for 24 hrs; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), INJECTION SITE SWELLING (The injection site swelled up), ERYTHEMA (Was bright red), PYREXIA (fever of 99.9°F for 24 hrs) and RASH (Got a red rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     I had no allergic reaction to any inoculations ever//form wont let me ok NO  on history march through April ran low grade fever occasionally,, , after taking my temp every other all of 2020...none in may.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for Postnasal drip, LOVASTATIN, OMEPRAZOLE and VITAMINS NOS for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 25-Jan-2021, the patient experienced INJECTION SITE SWELLING (The injection site swelled up), ERYTHEMA (Was bright red) and PYREXIA (fever of 99.9°F for 24 hrs). On 29-Jan-2021, the patient experienced RASH (Got a red rash) and INJECTION SITE WARMTH (Hot to touch). On an unknown date, the patient experienced FATIGUE (left me tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was sore), INJECTION SITE SWELLING (The injection site swelled up), ERYTHEMA (Was bright red), PYREXIA (fever of 99.9°F for 24 hrs), RASH (Got a red rash), INJECTION SITE WARMTH (Hot to touch) and FATIGUE (left me tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99.9°f (High) fever of 99.9°F for 24 hrs. On 29-Jan-2021, Body temperature: 98.3°f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: I iced my arm 16-01-2021:swolled red upper arm fever for 4 days   1 wk later fever for 2 days    all fever not above 100 13-02-2021 swollen red hard at injection site rash low grade fever   for 4 days I have described everything in the form, fever reaction left me tired  did call my doctor was told to report to moderna  which I did, so it should be on file   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: VAERS form is appended: patient states : fever reaction left me tired. Second dose information ,concomitants updated.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: ache in arm; arm feels warmer to the touch than other arm; reddish; A spontaneous report was received from a Consumer concerning a 91-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ache in arm, arm feels warmer to the touch than other arm, reddish, like a rash that's not raised.  The patient's medical history was not provided. Concomitant medications reported were synthroid, Tylenol PM for drug use for unknown indication.  No relevant lab data was reported by the reporter.  On 20 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.   ache in arm, arm feels warmer to the touch than other arm, reddish, like a rash that's not raised.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, ache in arm, On an unknown date the outcome of events, arm feels warmer to the touch than other arm, On an unknown date the outcome of events, reddish, On an unknown date the outcome of events, like a rash that's not raised was not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: diarrhea; muffled hearing in waves; Arm pain; Fatigue; BP went up to 159/94; "Maybe I was having a panic attack"; heart rate went up; heart rate went up and down in waves; warm sensation; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves) and HEART RATE INCREASED (heart rate went up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (BP went up to 159/94), FEELING HOT (warm sensation) and HEART RATE INCREASED (heart rate went up). 31-Jan-2021, the patient experienced HEART RATE DECREASED (heart rate went up and down in waves) and PANIC ATTACK ("Maybe I was having a panic attack"). On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HYPOACUSIS (muffled hearing in waves), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves), HEART RATE INCREASED (heart rate went up), HEART RATE DECREASED (heart rate went up and down in waves), PAIN IN EXTREMITY (Arm pain), PANIC ATTACK ("Maybe I was having a panic attack") and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Blood pressure measurement: 159/94 (High) BP went up to 159/94. On 31-Jan-2021, Heart rate: 97 (High) heart rate went up to 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome of the events updated to resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Heart rate increased, Hypoacusis, Pain in extremity
Clinical narrative: diarrhea; muffled hearing in waves; Arm pain; Fatigue; BP went up to 159/94; "Maybe I was having a panic attack"; heart rate went up; heart rate went up and down in waves; warm sensation; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves) and HEART RATE INCREASED (heart rate went up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (BP went up to 159/94), FEELING HOT (warm sensation) and HEART RATE INCREASED (heart rate went up). 31-Jan-2021, the patient experienced HEART RATE DECREASED (heart rate went up and down in waves) and PANIC ATTACK ("Maybe I was having a panic attack"). On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HYPOACUSIS (muffled hearing in waves), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves), HEART RATE INCREASED (heart rate went up), HEART RATE DECREASED (heart rate went up and down in waves), PAIN IN EXTREMITY (Arm pain), PANIC ATTACK ("Maybe I was having a panic attack") and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Blood pressure measurement: 159/94 (High) BP went up to 159/94. On 31-Jan-2021, Heart rate: 97 (High) heart rate went up to 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome of the events updated to resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: diarrhea; muffled hearing in waves; Arm pain; Fatigue; BP went up to 159/94; "Maybe I was having a panic attack"; heart rate went up; heart rate went up and down in waves; warm sensation; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves) and HEART RATE INCREASED (heart rate went up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (BP went up to 159/94), FEELING HOT (warm sensation) and HEART RATE INCREASED (heart rate went up). 31-Jan-2021, the patient experienced HEART RATE DECREASED (heart rate went up and down in waves) and PANIC ATTACK ("Maybe I was having a panic attack"). On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), HYPOACUSIS (muffled hearing in waves), PAIN IN EXTREMITY (Arm pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (BP went up to 159/94), DIARRHOEA (diarrhea), FEELING HOT (warm sensation), HYPOACUSIS (muffled hearing in waves), HEART RATE INCREASED (heart rate went up), HEART RATE DECREASED (heart rate went up and down in waves), PAIN IN EXTREMITY (Arm pain), PANIC ATTACK ("Maybe I was having a panic attack") and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Blood pressure measurement: 159/94 (High) BP went up to 159/94. On 31-Jan-2021, Heart rate: 97 (High) heart rate went up to 97.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome of the events updated to resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nasal congestion, Nasopharyngitis
Clinical narrative: worst fatigue; feels having a cold; nasal congestion; pain in the injection site; mild headache; tiredness; mild nausea; A spontaneous report was received from a Consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site pain , headache, fatigue, nausea, nasopharyngitis, nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Simvastatin for cholesterone, Buspirone for anxiety, Trazodone for anxiety, Zyrtec for allergy, Venlafaxine for depression, Preservision for macular degreneration, Calcium for Osteoporosis, Vitamin D for Osteoporosis for drug use for unknown indication.  On 27 Jan 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 27 Jan 2021, the patient experienced the events nausea, nasopharyngitis, nasal congestion.  On 30 Jan 2021, the patient experienced the events  headache, fatigue.  Treatment details included Tylenol yesterday  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Jan 2021 the outcome of events injection site pain  was resolved.On 31 Jan 2021 the outcome of events  headache was resolved.On 28 Jan 2021 the outcome of events fatigue was resolved.On 28 Jan 2021 the outcome of events  nausea was resolved.On 29 Jan 2021 the outcome of events feels having a cold was resolved.On 29 Jan 2021 the outcome of events nasal congestion was resolved.On 30 Jan 2021 the outcome of events  headache was resolved.On 30 Jan 2021 the outcome of events  fatigue was resolved.