chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: off and on dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (off and on dizziness) 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.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (off and on dizziness). At the time of the report, DIZZINESS (off and on dizziness) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: itchy skin; little red bumps popping up all over rashes; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchy skin) and RASH ERYTHEMATOUS (little red bumps popping up all over rashes) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRURITUS (itchy skin) and RASH ERYTHEMATOUS (little red bumps popping up all over rashes). At the time of the report, PRURITUS (itchy skin) and RASH ERYTHEMATOUS (little red bumps popping up all over rashes) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications included diphenhydramine, hydrocortisone cream
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: Lymph node swelling on the side of her face on right side; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling on the side of her face on right side) and TENDERNESS (Tenderness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 28-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph node swelling on the side of her face on right side) and TENDERNESS (Tenderness). At the time of the report, LYMPHADENOPATHY (Lymph node swelling on the side of her face on right side) and TENDERNESS (Tenderness) outcome was unknown.            Concomitant medications were not reported. Treatment information were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Fatigue; chills; Body ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (chills), PAIN (Body ache) and PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (chills), PAIN (Body ache) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue), CHILLS (chills), PAIN (Body ache) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment Received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: chest pain; hives all over the both legs; swelling lymph nodes; going down itchiness all over legs both side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), URTICARIA (hives all over the both legs), LYMPHADENOPATHY (swelling lymph nodes) and PRURITUS (going down itchiness all over legs both side) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B212A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHEST PAIN (chest pain), URTICARIA (hives all over the both legs), LYMPHADENOPATHY (swelling lymph nodes) and PRURITUS (going down itchiness all over legs both side). On 29-Mar-2021, URTICARIA (hives all over the both legs), LYMPHADENOPATHY (swelling lymph nodes) and PRURITUS (going down itchiness all over legs both side) had resolved. At the time of the report, CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  On 27 Mar 2021 at 1:00 pm the patient received first dose of Moderna vaccine. On 28 Mar 2021 at 3:00am the patient experienced hives all over the both legs, swelling lymph nodes, going down itchiness all over legs both side and at 10:00 am the patient experienced chest pain and also visited Physician. The Physician asked the patient to monitor this pain for two days because pain did not go away. The patient noticed that it was recently recovered from COVID. On 21 Mar 2021 the patient had already finished the quarantine.  Treatment for the events include Claritin   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye pruritus, Foreign body sensation in eyes, Limb discomfort
Clinical narrative: eyes feel scratchy like sand; weakness in her legs; unstable in her legs.; feels things in her eyes; dizziness, got dizzy when they gave her the vaccine; weakness in the body her body hurt, left arm still hurts inside the bone; she felt blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness , got dizzy when they gave her the vaccine), ASTHENIA (weakness in the body, MYALGIA (her body hurt, left arm still hurts inside the bone), VISION BLURRED (she felt blurry vision) and EYE PRURITUS (eyes feel scratchy like sand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tramadol). Concomitant products included thyroid medication, medications for arthritis, cholesterol medication, high blood pressure medication, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness, got dizzy when they gave her the vaccine, ASTHENIA (weakness in the body  MYALGIA (her body hurt, left arm still hurts inside the bone) and VISION BLURRED (she felt blurry vision). On an unknown date, the patient experienced EYE PRURITUS (eyes feel scratchy like sand), MUSCULAR WEAKNESS (weakness in her legs), LIMB DISCOMFORT (unstable in her legs.) and FOREIGN BODY SENSATION IN EYES (feels things in her eyes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, DIZZINESS, got dizzy when they gave her the vaccine) had resolved. On 08-Mar-2021, ASTHENIA (weakness in the body and MYALGIA (her body hurt left arm still hurts inside the bone) had resolved. At the time of the report, VISION BLURRED (she felt blurry vision), EYE PRURITUS (eyes feel scratchy like sand), MUSCULAR WEAKNESS (weakness in her legs), LIMB DISCOMFORT (unstable in her legs.) and FOREIGN BODY SENSATION IN EYES (feels things in her eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol as a treatment medication for her symptoms for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: addition of new events MUSCULAR WEAKNESS (weakness in her legs), LIMB DISCOMFORT (unstable in her legs ) and FOREIGN BODY SENSATION IN EYES (feels things in her eyes) were added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Vision blurred
Clinical narrative: eyes feel scratchy like sand; weakness in her legs; unstable in her legs.; feels things in her eyes; dizziness, got dizzy when they gave her the vaccine; weakness in the body her body hurt, left arm still hurts inside the bone; she felt blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness , got dizzy when they gave her the vaccine), ASTHENIA (weakness in the body, MYALGIA (her body hurt, left arm still hurts inside the bone), VISION BLURRED (she felt blurry vision) and EYE PRURITUS (eyes feel scratchy like sand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tramadol). Concomitant products included thyroid medication, medications for arthritis, cholesterol medication, high blood pressure medication, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizziness, got dizzy when they gave her the vaccine, ASTHENIA (weakness in the body  MYALGIA (her body hurt, left arm still hurts inside the bone) and VISION BLURRED (she felt blurry vision). On an unknown date, the patient experienced EYE PRURITUS (eyes feel scratchy like sand), MUSCULAR WEAKNESS (weakness in her legs), LIMB DISCOMFORT (unstable in her legs.) and FOREIGN BODY SENSATION IN EYES (feels things in her eyes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, DIZZINESS, got dizzy when they gave her the vaccine) had resolved. On 08-Mar-2021, ASTHENIA (weakness in the body and MYALGIA (her body hurt left arm still hurts inside the bone) had resolved. At the time of the report, VISION BLURRED (she felt blurry vision), EYE PRURITUS (eyes feel scratchy like sand), MUSCULAR WEAKNESS (weakness in her legs), LIMB DISCOMFORT (unstable in her legs.) and FOREIGN BODY SENSATION IN EYES (feels things in her eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took Tylenol as a treatment medication for her symptoms for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: addition of new events MUSCULAR WEAKNESS (weakness in her legs), LIMB DISCOMFORT (unstable in her legs ) and FOREIGN BODY SENSATION IN EYES (feels things in her eyes) were added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain in the left arm at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain in the left arm at the site of the injection) 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.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Severe pain in the left arm at the site of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Severe pain in the left arm at the site of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication reported included acetaminophen.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Headache, Myalgia
Clinical narrative: Starting to get dizzy; Even came down with cold; Even fell a few times due to that; Almost hit my head on the floor; Week after the shot, my arm swelled up; Arm swelled up it became veryred and painful; Arm swelled up it became veryred and painful; Pounding headache after few days of the shot; Whole body was aching form top to bottom of my toes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Starting to get dizzy), NASOPHARYNGITIS (Even came down with cold), FALL (Even fell a few times due to that), HEAD INJURY (Almost hit my head on the floor) and PERIPHERAL SWELLING (Week after the shot, my arm swelled up) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Starting to get dizzy), NASOPHARYNGITIS (Even came down with cold), FALL (Even fell a few times due to that), HEAD INJURY (Almost hit my head on the floor), PERIPHERAL SWELLING (Week after the shot, my arm swelled up), VACCINATION SITE ERYTHEMA (Arm swelled up it became veryred and painful), VACCINATION SITE PAIN (Arm swelled up it became veryred and painful), HEADACHE (Pounding headache after few days of the shot) and MYALGIA (Whole body was aching form top to bottom of my toes). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Starting to get dizzy), NASOPHARYNGITIS (Even came down with cold), FALL (Even fell a few times due to that), HEAD INJURY (Almost hit my head on the floor), VACCINATION SITE ERYTHEMA (Arm swelled up it became veryred and painful) and HEADACHE (Pounding headache after few days of the shot) outcome was unknown and PERIPHERAL SWELLING (Week after the shot, my arm swelled up), VACCINATION SITE PAIN (Arm swelled up it became veryred and painful) and MYALGIA (Whole body was aching form top to bottom of my toes) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Starting to get dizzy; Even came down with cold; Even fell a few times due to that; Almost hit my head on the floor; Week after the shot, my arm swelled up; Arm swelled up it became veryred and painful; Arm swelled up it became veryred and painful; Pounding headache after few days of the shot; Whole body was aching form top to bottom of my toes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Starting to get dizzy), NASOPHARYNGITIS (Even came down with cold), FALL (Even fell a few times due to that), HEAD INJURY (Almost hit my head on the floor) and PERIPHERAL SWELLING (Week after the shot, my arm swelled up) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Starting to get dizzy), NASOPHARYNGITIS (Even came down with cold), FALL (Even fell a few times due to that), HEAD INJURY (Almost hit my head on the floor), PERIPHERAL SWELLING (Week after the shot, my arm swelled up), VACCINATION SITE ERYTHEMA (Arm swelled up it became veryred and painful), VACCINATION SITE PAIN (Arm swelled up it became veryred and painful), HEADACHE (Pounding headache after few days of the shot) and MYALGIA (Whole body was aching form top to bottom of my toes). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Starting to get dizzy), NASOPHARYNGITIS (Even came down with cold), FALL (Even fell a few times due to that), HEAD INJURY (Almost hit my head on the floor), VACCINATION SITE ERYTHEMA (Arm swelled up it became veryred and painful) and HEADACHE (Pounding headache after few days of the shot) outcome was unknown and PERIPHERAL SWELLING (Week after the shot, my arm swelled up), VACCINATION SITE PAIN (Arm swelled up it became veryred and painful) and MYALGIA (Whole body was aching form top to bottom of my toes) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: moderna vaccine was given to two 17 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine was given to two 17 years old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine was given to two 17 years old). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine was given to two 17 years old) 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.   This case was linked to MOD-2021-059902 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Pain in arms and legs; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arms and legs), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Heart disease, unspecified and Cholesterol. Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN) for Heart disease, unspecified.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arms and legs), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arms and legs), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI- patient denied further follow-up
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Bad Smell; Bad Smell; Bad Taste; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Bad Taste), the first episode of PAROSMIA (Bad Smell) and the second episode of PAROSMIA (Bad Smell) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event (No medical history.).    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TASTE DISORDER (Bad Taste). On 25-Mar-2021, the patient experienced the first episode of PAROSMIA (Bad Smell). On 30-Mar-2021, the patient experienced the second episode of PAROSMIA (Bad Smell). At the time of the report, TASTE DISORDER (Bad Taste) and the last episode of PAROSMIA (Bad Smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test
Clinical narrative: Absence of period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Absence of period) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (Absence of period). At the time of the report, MENSTRUATION DELAYED (Absence of period) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative (Negative) negative.         No concomitant medications reported.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-034448 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at injection site; Redness at injection site; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 28-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Diabetes medicines and High blood pressure medicine.  Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI-  Patient doesnot want to continue with the follow up.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received two doses of the Moderna Covid-19 vaccine within 2 days; A spontaneous report was received from a other healthcare professional concerning a patient (age and gender unknown) who received two doses of the Moderna's Covid-19 vaccine within 2 days (Inappropriate schedule of product administration).   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 and within two days of the first dose the patient received their second dose of mRNA-1273 for prophylaxis of COVID-19 infection. They wanted to know what should be done with the official second dose of the vaccine. No further details were provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event received two doses of mRNA-1273 vaccine within two days was considered resolved.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown with no associated AEs.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes; She started with pain in her left shoulder next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (She started with pain in her left shoulder next day after receiving 2nd dose) and PAIN (After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (She started with pain in her left shoulder next day after receiving 2nd dose). On an unknown date, the patient experienced PAIN (After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes). At the time of the report, ARTHRALGIA (She started with pain in her left shoulder next day after receiving 2nd dose) and PAIN (After a day and half, she started with shooting pain with pressure in her tempo on her head by left side of eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: took the vaccine two months ago and need to know if i can do an appointment for the second; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the vaccine two months ago and need to know if i can do an appointment for the second) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the vaccine two months ago and need to know if i can do an appointment for the second). On 17-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the vaccine two months ago and need to know if i can do an appointment for the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #039K202a, with no associated AEs.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Eye swelling, Fatigue, Feeling abnormal
Clinical narrative: Eye swelled up; FEELING HORRIBLE; Heart palpitation came on suddenly; Shortness of breath; Fatigue is continuous; Muscle aches; Pains in the joints; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue is continuous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event and COVID-19.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue is continuous), MYALGIA (Muscle aches) and ARTHRALGIA (Pains in the joints). At the time of the report, EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue is continuous), MYALGIA (Muscle aches) and ARTHRALGIA (Pains in the joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations
Clinical narrative: Eye swelled up; FEELING HORRIBLE; Heart palpitation came on suddenly; Shortness of breath; Fatigue is continuous; Muscle aches; Pains in the joints; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue is continuous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event and COVID-19.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue is continuous), MYALGIA (Muscle aches) and ARTHRALGIA (Pains in the joints). At the time of the report, EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue is continuous), MYALGIA (Muscle aches) and ARTHRALGIA (Pains in the joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Rash
Clinical narrative: rash, left arm small area; Fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash, left arm small area), INJECTION SITE PAIN (pain at injection site) and FATIGUE (Fatigue) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 03-Mar-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced RASH (rash, left arm small area). On 04-Mar-2021, INJECTION SITE PAIN (pain at injection site) had resolved. On 06-Mar-2021, RASH (rash, left arm small area) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: bodyaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyaches) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (bodyaches) and PYREXIA (fever). At the time of the report, PAIN (bodyaches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication include ibuprofen.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Inflammation, Myalgia, Paraesthesia
Clinical narrative: Numbly in hands; Tingly in hands; When you touch her skin it gets inflamed; Feels like her body is reacting to something; Developed a massive rash; Muscle soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbly in hands), PARAESTHESIA (Tingly in hands), INFLAMMATION (When you touch her skin it gets inflamed), FEELING ABNORMAL (Feels like her body is reacting to something) and RASH (Developed a massive rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Acid reflux and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HYPOAESTHESIA (Numbly in hands), PARAESTHESIA (Tingly in hands), INFLAMMATION (When you touch her skin it gets inflamed), FEELING ABNORMAL (Feels like her body is reacting to something), RASH (Developed a massive rash) and MYALGIA (Muscle soreness). At the time of the report, HYPOAESTHESIA (Numbly in hands), PARAESTHESIA (Tingly in hands), INFLAMMATION (When you touch her skin it gets inflamed), FEELING ABNORMAL (Feels like her body is reacting to something), RASH (Developed a massive rash) and MYALGIA (Muscle soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.         Treatment medication include cortisone, prednisone, muscle relaxants, steroids and Prozac.  Patient had a MRI on her brain and neck. Patient received the second dose of moderna vaccine and symptoms got worse.     This case was linked to MOD21-065644, MOD21-065708 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Numbly in hands; Tingly in hands; When you touch her skin it gets inflamed; Feels like her body is reacting to something; Developed a massive rash; Muscle soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbly in hands), PARAESTHESIA (Tingly in hands), INFLAMMATION (When you touch her skin it gets inflamed), FEELING ABNORMAL (Feels like her body is reacting to something) and RASH (Developed a massive rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Acid reflux and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HYPOAESTHESIA (Numbly in hands), PARAESTHESIA (Tingly in hands), INFLAMMATION (When you touch her skin it gets inflamed), FEELING ABNORMAL (Feels like her body is reacting to something), RASH (Developed a massive rash) and MYALGIA (Muscle soreness). At the time of the report, HYPOAESTHESIA (Numbly in hands), PARAESTHESIA (Tingly in hands), INFLAMMATION (When you touch her skin it gets inflamed), FEELING ABNORMAL (Feels like her body is reacting to something), RASH (Developed a massive rash) and MYALGIA (Muscle soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.         Treatment medication include cortisone, prednisone, muscle relaxants, steroids and Prozac.  Patient had a MRI on her brain and neck. Patient received the second dose of moderna vaccine and symptoms got worse.     This case was linked to MOD21-065644, MOD21-065708 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Memory impairment
Clinical narrative: Felt so light headed, dizziness; she wasn't able to remember things; A spontaneous report was received from an 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dizziness (Felt so light headed, dizziness)  and Memory impairment (she wasn't able to remember things).  The patient's medical history was not provided. Relevant concomitant medications include Rosuvastatin and vitamins. On 19 Jan 2021, 5 days prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 016b21a) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 MAR 2021 8:40 am,  the patient  experienced Dizziness and Memory impairment.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not reported..  The outcome of events Dizziness and Memory impairment was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: outbreaks on both his upper legs that looked like poison ivy; area is itchy on both legs; rash is on both legs in similar spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH (outbreaks on both his upper legs that looked like poison ivy), PRURITUS (area is itchy on both legs) and RASH (rash is on both legs in similar spots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH (outbreaks on both his upper legs that looked like poison ivy), PRURITUS (area is itchy on both legs) and RASH (rash is on both legs in similar spots). At the time of the report, RASH (outbreaks on both his upper legs that looked like poison ivy), PRURITUS (area is itchy on both legs) and RASH (rash is on both legs in similar spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Tired; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Low grade fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Low grade fever). At the time of the report, FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: has not felt good; headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has not felt good) and HEADACHE (headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (has not felt good) and HEADACHE (headaches). At the time of the report, FEELING ABNORMAL (has not felt good) and HEADACHE (headaches) outcome was unknown.            No concomitant product information was reported.  No treatment information was reported.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Illness, Nausea, Vertigo
Clinical narrative: Nauseous; Fell very ill; Stomach was very upset; Dizziness; Developed severe vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), ILLNESS (Fell very ill), ABDOMINAL DISCOMFORT (Stomach was very upset), DIZZINESS (Dizziness) and VERTIGO (Developed severe vertigo) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous), ILLNESS (Fell very ill), ABDOMINAL DISCOMFORT (Stomach was very upset), DIZZINESS (Dizziness) and VERTIGO (Developed severe vertigo). At the time of the report, NAUSEA (Nauseous), ILLNESS (Fell very ill), ABDOMINAL DISCOMFORT (Stomach was very upset), DIZZINESS (Dizziness) and VERTIGO (Developed severe vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe joint pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     The patient's past medical history included No adverse event.   On 27-Mar-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 ARTHRALGIA (severe joint pain). At the time of the report, ARTHRALGIA (severe joint pain) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dyspnea (shortness of breath) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022M21A) for COVID-19 immunization. The patient's past medical history included no historical condition reported. On Feb 26, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient experienced dyspnea (shortness of breath). At the time of the report, dyspnea (shortness of breath) outcome: unknown. No concomitant medication or treatment information reported. No adverse event after the second dose. Action taken with mRNA-1273 in response to the events: not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) 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 reaction (No medical history provided by the reporter.). On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment medication was reported by the patient.