chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Redness as big as hives, feels warmth and swollen on the injection site; Chills; Redness; Redness as big as hives, feels warmth and swollen on the injection site; Redness as big as hives, feels warmth and swollen on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Redness as big as hives, feels warmth and swollen on the injection site), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE WARMTH (Redness as big as hives, feels warmth and swollen on the injection site) and VACCINATION SITE SWELLING (Redness as big as hives, feels warmth and swollen on the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE for Antidepressant therapy, PRAVASTATIN for Cholesterol, HYDROCHLOROTHIAZIDE for Fluid retention, METOPROLOL and ANASTROZOLE for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Redness as big as hives, feels warmth and swollen on the injection site), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE WARMTH (Redness as big as hives, feels warmth and swollen on the injection site) and VACCINATION SITE SWELLING (Redness as big as hives, feels warmth and swollen on the injection site). At the time of the report, VACCINATION SITE URTICARIA (Redness as big as hives, feels warmth and swollen on the injection site), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE WARMTH (Redness as big as hives, feels warmth and swollen on the injection site) and VACCINATION SITE SWELLING (Redness as big as hives, feels warmth and swollen on the injection site) 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.   She had applied ice as a treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: arm is pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is pink) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is pink). At the time of the report, VACCINATION SITE ERYTHEMA (arm is pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment drugs were provided.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: skin has been reacting; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin has been reacting) 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 07-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 SKIN REACTION (skin has been reacting). At the time of the report, SKIN REACTION (skin has been reacting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication reported.   No treatment information provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness arm; General ache; Tenderness at the injection site; Chills; Headache; A spontaneous report (United States) was received from a female patient concerning herself, a 23 years old female patient, who received Moderna (mRNA-1273) and developed soreness arm, general ache, tenderness at the injection site, chills and headache.   The patient's medical history was not provided. Concomitant product use was not provided.   On 17 Jan 2021 10.30 AM, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, after vaccination, the patient experienced soreness arm, general ache, tenderness at the injection site, chills and headache. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events soreness arm, general ache, tenderness at the injection site, chills and headache were considered not recovered at the time of this report.; Reporter's Comments: This case concerns a 23-year-old female who experienced a NS unexpected events of pain in extremity and pain and NS expected events of Vaccination site tenderness, headache, chills.  The events occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events ongoing. 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: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Warmer than the normal part; Red welt where I had the shot; itchy a little bit; red arm; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmer than the normal part), VACCINATION SITE URTICARIA (Red welt where I had the shot), VACCINATION SITE PRURITUS (itchy a little bit), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE ERYTHEMA (red arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchy a little bit) and VACCINATION SITE ERYTHEMA (red arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmer than the normal part) and VACCINATION SITE URTICARIA (Red welt where I had the shot). At the time of the report, VACCINATION SITE WARMTH (Warmer than the normal part), VACCINATION SITE URTICARIA (Red welt where I had the shot) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown and VACCINATION SITE PRURITUS (itchy a little bit) and VACCINATION SITE ERYTHEMA (red arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's arm is red and a little bit itchy, but they mentioned it is getting better now and is almost gone.  No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Arm is itching at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm is itching at the site of injection) 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 SITE PRURITUS (Arm is itching at the site of injection). At the time of the report, VACCINATION SITE PRURITUS (Arm is itching at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itchy at the injection site; developed an area of redness; A spontaneous report was received from a physician concerning a 73- year old female patient who received Modena's COVID-19 vaccine (mRNA-1273) and developed an area of redness and itchy at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09 Jan 2021, approximately nine days prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  The patient was fine for a week however, on 17 Jan 2021, she developed an area of redness and itchiness at the injection site which measured 3 by 6 inches. She had her next injection scheduled in 2 weeks. The physician wanted to know whether the reaction to the vaccine was usually seen a week after the vaccination and howthe patient would be treated and when could she get the second dose of the vaccine.  No laboratory data and treatment drugs were reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events developed an area of redness and itchy at the injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Soreness in the arm; very tired/fatigue; fever - was 100 up to 101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever - was 100 up to 101), FATIGUE (very tired/fatigue) and VACCINATION SITE PAIN (Soreness in the arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (fever - was 100 up to 101). On 15-Jan-2021, the patient experienced FATIGUE (very tired/fatigue). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). At the time of the report, PYREXIA (fever - was 100 up to 101) and FATIGUE (very tired/fatigue) had not resolved and VACCINATION SITE PAIN (Soreness in the arm) 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.   No relevant concomitant medications were reported.   Patient started having fever started on 14-Jan-2021, fever was 100 up to 101, it drops periodically but still hanged in there. Patient reports that he had fever today (at the time of reporting) and has fatigue as well. He reported that soreness in the arm had gone.  Patient took Tylenol and Aspirin for treatment.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She have hives and it is now all over her body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She have hives and it is now all over her body) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (She have hives and it is now all over her body). At the time of the report, URTICARIA (She have hives and it is now all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment activities for event was done with zyrtec..
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm was super hot and burns; arm was itchy; arm was swollen; arm was red; feels very tired; arm was super hot and burns; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red) and FATIGUE (feels very tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm was super hot and burns). At the time of the report, VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm was super hot and burns) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patient took Tylenol and Benadryl for treatment.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm was super hot and burns; arm was itchy; arm was swollen; arm was red; feels very tired; arm was super hot and burns; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red) and FATIGUE (feels very tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-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 VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm was super hot and burns). At the time of the report, VACCINATION SITE WARMTH (arm was super hot and burns), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE ERYTHEMA (arm was red), FATIGUE (feels very tired) and VACCINATION SITE PAIN (arm was super hot and burns) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patient took Tylenol and Benadryl for treatment.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L208A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment includes hydrocodone for pain. No concomitant drugs are provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. Received consumer call: I notice 4:30 in the morning I fell a little dizzy, I got my shot 4 days ago - (January 14). I am taking hydrocodone for pain. They said that I will get this side effects few minutes after vaccination but I had this after 4 days I received the vaccine, is this normal? Vaccinated at remote site a warehouse; Lot Number: 013L208A Consented for follow-up at anytime 18Jan2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Felt some body malaise; Injection site became very red and itchy again; Injection site became very red; Normal soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt some body malaise), PAIN IN EXTREMITY (Normal soreness), VACCINATION SITE PRURITUS (Injection site became very red and itchy again) and VACCINATION SITE ERYTHEMA (Injection site became very red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (past medical history not provided).    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Normal soreness). On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt some body malaise), VACCINATION SITE PRURITUS (Injection site became very red and itchy again) and VACCINATION SITE ERYTHEMA (Injection site became very red). At the time of the report, VACCINATION COMPLICATION (Felt some body malaise), PAIN IN EXTREMITY (Normal soreness), VACCINATION SITE PRURITUS (Injection site became very red and itchy again) and VACCINATION SITE ERYTHEMA (Injection site became very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: No taste; no smell; COVID-19; low grade fever; chills; headache; coughing; A spontaneous report was received from a Healthcare professional, concerning a female patient of age 60 , who received Moderna's COVID-19 vaccine and experienced cough/coughing, pyrexia/low grade fever, chills, headache, ageusia/no taste, anosmia/no smell, COVID-19.  The patient is getting active radiation therapy. Concomitant product use was not provided by the reporter.  On 08-Jan-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (027L20A) via intramuscular route on her right deltoid  for COVID-19 infection prophylaxis.   On 08-Jan-2021, after first dose of vaccine, the patient experienced some common symptoms such as coughing. Next day, that is 09-Jan-2021 she ran a low grade fever, chills and a headache.  She thought these were side effects from the Moderna COVID-19 vaccine. She took Tylenol for the headache which helped it go away. The next day 10-Jan-2021 someone in the office said that she is around a lot tested positive for COVID so she went to get a test and came up positive. Right now she does not have a taste or smell and she is coughing a bit but over all she feels fine.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, coughing, no taste, no smell was considered to be not recovered/ not resolved. The outcome of the event, low grade fever, chills and headache was considered to be recovered/ resolved. The outcome of the event COVID-19 positive was considered to be unknown at the time of this report.  She took a test and tested positive for COVID. She took Tylenol for the headache which helped it go away.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: No taste; no smell; COVID-19; low grade fever; chills; headache; coughing; A spontaneous report was received from a Healthcare professional, concerning a female patient of age 60 , who received Moderna's COVID-19 vaccine and experienced cough/coughing, pyrexia/low grade fever, chills, headache, ageusia/no taste, anosmia/no smell, COVID-19.  The patient is getting active radiation therapy. Concomitant product use was not provided by the reporter.  On 08-Jan-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (027L20A) via intramuscular route on her right deltoid  for COVID-19 infection prophylaxis.   On 08-Jan-2021, after first dose of vaccine, the patient experienced some common symptoms such as coughing. Next day, that is 09-Jan-2021 she ran a low grade fever, chills and a headache.  She thought these were side effects from the Moderna COVID-19 vaccine. She took Tylenol for the headache which helped it go away. The next day 10-Jan-2021 someone in the office said that she is around a lot tested positive for COVID so she went to get a test and came up positive. Right now she does not have a taste or smell and she is coughing a bit but over all she feels fine.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, coughing, no taste, no smell was considered to be not recovered/ not resolved. The outcome of the event, low grade fever, chills and headache was considered to be recovered/ resolved. The outcome of the event COVID-19 positive was considered to be unknown at the time of this report.  She took a test and tested positive for COVID. She took Tylenol for the headache which helped it go away.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lymphadenopathy, Vaccination site pruritus
Clinical narrative: Hypersensitivity; Axillary Lymph nodes; Slight itchiness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity), LYMPHADENOPATHY (Axillary Lymph nodes) and VACCINATION SITE PRURITUS (Slight itchiness on the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (Axillary Lymph nodes) and VACCINATION SITE PRURITUS (Slight itchiness on the injection site). On 13-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity). At the time of the report, HYPERSENSITIVITY (Hypersensitivity), LYMPHADENOPATHY (Axillary Lymph nodes) and VACCINATION SITE PRURITUS (Slight itchiness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 11-jan-2021,the patient noticed that she have Axillary Lymph nodes and slight Itchiness on the injection site and Hypersensitivity on day 8 (1/13/21). Treatment information included,400 mg of ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Disorientation, Feeling hot, Headache
Clinical narrative: headache; stomach cramps; feel hot; burning sensation in chest; burning sensaton in arms; disorientation; A spontaneous report was received from a consumer concerning a 86 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced disorientation, headache, stomach cramps, feeling of warmth, chest burning and feeling pain.  The patient's medical history were not reported and concomitant medication were Plavix, Januvia, Simvastatin, Progesterone, Vivelle.  06Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not reported) via intramuscular rout for prophylaxis of COVID-19 infection.  On 08Jan2021, the patient experienced disorientation. On 12Jan2021, the patient experienced headache, stomach cramps, feeling of warmth, chest burning and feeling pain. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events disorientation, headache, stomach cramps, feeling of warmth, chest burning and feeling pain is Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: headache; stomach cramps; feel hot; burning sensation in chest; burning sensaton in arms; disorientation; A spontaneous report was received from a consumer concerning a 86 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced disorientation, headache, stomach cramps, feeling of warmth, chest burning and feeling pain.  The patient's medical history were not reported and concomitant medication were Plavix, Januvia, Simvastatin, Progesterone, Vivelle.  06Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not reported) via intramuscular rout for prophylaxis of COVID-19 infection.  On 08Jan2021, the patient experienced disorientation. On 12Jan2021, the patient experienced headache, stomach cramps, feeling of warmth, chest burning and feeling pain. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events disorientation, headache, stomach cramps, feeling of warmth, chest burning and feeling pain is Unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Flushing, Pain in extremity
Clinical narrative: Face was flushed; Lost her appetite; Delayed swelling; Arm was tender to the touch; Chills; Could not lift her arm; Arm started to hurt; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling) and TENDERNESS (Arm was tender to the touch) in a 70-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 PPD skin test positive (Medical history of a positive PPD.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm) and PAIN IN EXTREMITY (Arm started to hurt). On an unknown date, the patient experienced FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling), TENDERNESS (Arm was tender to the touch), PYREXIA (Fever of 102F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SULINDAC (CLINORIL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling), TENDERNESS (Arm was tender to the touch) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Arm started to hurt) and PYREXIA (Fever of 102F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f (abnormal) 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs provided.  No treatment drugs provided.   This case was linked to MOD-2021-238129 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Additional information received included the patient did not consult the primary care physician for the events.No new information added. On 28-Jun-2021: follow up received: 2nd dose AE's reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tenderness, Vaccination site movement impairment
Clinical narrative: Face was flushed; Lost her appetite; Delayed swelling; Arm was tender to the touch; Chills; Could not lift her arm; Arm started to hurt; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling) and TENDERNESS (Arm was tender to the touch) in a 70-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 PPD skin test positive (Medical history of a positive PPD.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm) and PAIN IN EXTREMITY (Arm started to hurt). On an unknown date, the patient experienced FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling), TENDERNESS (Arm was tender to the touch), PYREXIA (Fever of 102F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SULINDAC (CLINORIL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FLUSHING (Face was flushed), DECREASED APPETITE (Lost her appetite), PERIPHERAL SWELLING (Delayed swelling), TENDERNESS (Arm was tender to the touch) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Arm started to hurt) and PYREXIA (Fever of 102F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102f (abnormal) 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs provided.  No treatment drugs provided.   This case was linked to MOD-2021-238129 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Additional information received included the patient did not consult the primary care physician for the events.No new information added. On 28-Jun-2021: follow up received: 2nd dose AE's reported
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 102.6 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102.6 fever) 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) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PYREXIA (102.6 fever). At the time of the report, PYREXIA (102.6 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Pyrexia: 102.6 (High) I now have 102.6 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products are not provided by the reporter. Patient was inquiring about taking ibuprofen or paracetamol but did not report taking it.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache- left side of my head; Generalised aching; Aching all over the body; soreness arm; A spontaneous report was received from a reporter like a consumer concerning a female patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like soreness arm/pain in extremity, aching all over the body/pain, fever/pyrexia, headache-left side of her hand/headache. The patient's medical history was not provided. No concomitant medications were reported. On 12 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection. On 15 Jan 2021, she experienced soreness arm, aching all over the body on 16 Jan 2021,  she started having fever, headache- left side of my head and generalized aching on 17 Jan 2021. Laboratory details were not reported. Treatment information included advil and tylenol . The outcome of the event was unknown. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tongue felt really weird and started tingling; A spontaneous report was received from a Consumer concerning an unknown Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event: Paraesthesia Oral.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, Caller received the moderna covid 19 vaccine which has been recalled with some issues. He had read about a situation where an individual could not feel their tongue after receiving the vaccine. 20-15 minutes after he received his vaccine, he had some water then his tongue felt really weird and started tingling which dissipated after a couple of minutes.  Laboratory details were not provided.  No treatment information was provided as the event dissipated after a couple of minutes.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event: tingling on tongue was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Have SIRVA; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced SIRVA/Administration site reaction. .  The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of event, the patient received a dose of mRNA-1273 (batch number unknown) via intramuscular route for COVID-19 infection prophylaxis. This case is cross-linked to MOD21-03580.   On 18-Jan-2021, the patient called and stated she has new information since her previous call. The patient contacted CDC and learned that she has SIRVA and it could be a vaccine administration issue.  Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, SIRVA was considered to be not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: sore arm; redness; sharp on and off headache; A spontaneous report was received from a consumer concerning a 39 year old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced Pain in arm, Redness, headache.  The patient's medical history and concomitant medication were not reported.  12-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route of administration for prophylaxis of COVID-19 infection.  On 12-Jan-2021, The patient experienced Pain in arm, Redness and headache. No Laboratory details provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events Pain in arm, Redness, is recovered and headache is Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm  Sore; A spontaneous report was received from a consumer concerning a 23- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in arm.  The patient's medical history was not provided.concomitant medications included,Larin for birth control.   On 16-jan-2021,prior to the onset of the events, the patient received their planned dose of mRNA-1273 (lot/batch 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16-jan-2021,the patient experienced arm sore until today. No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown. The outcome of the event pain in extremity was considered as unknown at the time of the report.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: terrible sore throat; A spontaneous report was received from a consumer concerning a 86-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible sore throat.  The patient's medical history is not provided by the reporter, Concomitant medications reported include Aspirin 81mg, Metformin, Amlodipine, Vitamin B12, Imodium as needed, Metoprolol and Lisinopril for unknown indications.  On 14-JAN-2021  got the first dose of the vaccine on her right arm at Hospital, for the prophylaxis of COVID-19 infection. Patient has been fine until 17-Jan-2021 she got a terrible sore throat.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is Unknown.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Swollen left arm; Swollen breast; Sore on left arm; Sore on breast; Pain in injection site; A spontaneous report was received from a female patient concerning herself, of unspecified age, who received Moderna (mRNA-1273) and developed swollen left arm (peripheral swelling), swollen breast (breast swelling) and pain in injection site (injection site pain) on 15 Jan 2021.   The patient's medical history was not provided. Concomitant product use was not provided.   The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on 14 Jan 2021 for prophylaxis of COVID-19 infection.   Treatment for the event was not provided.  The events swollen left arm and pain in injection site were considered to be non-serious and listed and the event swollen breast was found to be unlisted.  The consumer did not assess the causality of events.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events swollen left arm, swollen breast and pain in injection site were unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of pain in extremity, peripheral swelling, breast pain, breast swelling and nonserious expected vaccination site pain.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; A spontaneous case report was received from a consumer concerning a female patient, of unknown age, who administered Moderna's  COVID 19 Vaccine   The Patient Medical History was not provided. no relevant concomitant medications were reported.   on 18/JAN/2021, the patient experienced Fever 99.3 °F after 100 °F and then got down to 99.3 F.  Action taken with the second dose of mRNA-1273  in response to the event was not reported.  Report Source- Non-Health Professional,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,Outcome- Fever - Recovered/Resolved.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on both arms and legs; A spontaneous report was received from a Consumer concerning a 83 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event: rash.  The patient's medical history includes Stroke. Relevant concomitant medications reported include Lipitor, amlodipine and some she can't remember.    On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Patient received the Moderna vaccine on Saturday, 16-Jan 2021 on left arm. Woke up the next day with both arms with rashes as well as legs. She took a Benadryl for the treatment of rashes. The rashes have not gotten worse but are still there. She is taking lipitor, amlodipine and she can't remember. Medical history includes stroke.    Laboratory details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event, rash on both arms and legs were unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia, Vaccination site swelling
Clinical narrative: Metal Taste in mouth; Skin was Tingling; Swollen on injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal Taste in mouth), PARAESTHESIA (Skin was Tingling) and VACCINATION SITE SWELLING (Swollen on injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L204) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metal Taste in mouth), PARAESTHESIA (Skin was Tingling) and VACCINATION SITE SWELLING (Swollen on injection). At the time of the report, DYSGEUSIA (Metal Taste in mouth), PARAESTHESIA (Skin was Tingling) and VACCINATION SITE SWELLING (Swollen on injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events was not reported by reporter.  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.   This case was linked to MOD-2021-080885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up received on 24 May 2021 included no new information.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Sleep disorder, Vaccination site pain, Vaccination site swelling
Clinical narrative: Painful and I cannot lift it again; At night it woke me up; Woke me up because it's painful and I cannot lift it again; Injection site pain; Injection site pain and swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful and I cannot lift it again), SLEEP DISORDER (At night it woke me up), LIMB DISCOMFORT (Woke me up because it's painful and I cannot lift it again), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE SWELLING (Injection site pain and swelling) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition found).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 D-antigen units. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Painful and I cannot lift it again), SLEEP DISORDER (At night it woke me up), LIMB DISCOMFORT (Woke me up because it's painful and I cannot lift it again), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE SWELLING (Injection site pain and swelling). At the time of the report, PAIN IN EXTREMITY (Painful and I cannot lift it again), LIMB DISCOMFORT (Woke me up because it's painful and I cannot lift it again), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE SWELLING (Injection site pain and swelling) had not resolved and SLEEP DISORDER (At night it woke me up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Ibuprofen but it was not working.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching; Redness; swelling that's getting bigger at the injection site; spontaneous report was received from a non health professional (nurse) of un specified gender, concerning a female patient of 61years age, who received Moderna's COVID-19 vaccine and experienced itching, swelling at  the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On Jan 8th prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route.  Jan 15th - Itching, Redness and swelling that's getting bigger at the injection site. 17JAN2021  patient  had taken treatment of Benadryl and ibuprofen.  Action taken with mRNA-1273 in response to the event was unknown, de-challenge unknown, re challenge unknown.  The outcome of the event,  was considered to be unknown at the time of this report.; 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.