chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Hurt alot; Sore arm; Red lump with a 2 inch diameter; it was tender, sore and itchy; it was tender, sore and itchy; Red lump with a 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, ATENOLOL and METFORMIN for an unknown indication.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Red lump with a 2 inch diameter), VACCINATION SITE PRURITUS (it was tender, sore and itchy), VACCINATION SITE PAIN (it was tender, sore and itchy) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 23-Feb-2021, PAIN (Hurt alot), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (it was tender, sore and itchy) and VACCINATION SITE PAIN (it was tender, sore and itchy) had resolved. At the time of the report, VACCINATION SITE MASS (Red lump with a 2 inch diameter) and VACCINATION SITE ERYTHEMA (Red lump with a 2 inch diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had mild symptoms, not that severe effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had mild symptoms, not that severe effects) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had mild symptoms, not that severe effects). At the time of the report, VACCINATION COMPLICATION (had mild symptoms, not that severe effects) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Very weak; Trouble breathing; Fever; Very nauseous; Shaky; Kind of dizzy; Bad headache; Muscle ache/ full on body ache; Fatigue (couldn't do anything but sit on the couch)/ very tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy) and HEADACHE (Bad headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced TREMOR (Shaky), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache) and FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired). 09-Mar-2021, the patient experienced DIZZINESS (Kind of dizzy). On 14-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing), ASTHENIA (Very weak), PYREXIA (Fever) and NAUSEA (Very nauseous). At the time of the report, DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache), FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired), PYREXIA (Fever) and NAUSEA (Very nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 09-Mar-2021, the patient had muscle aches and on 14-Mar-2021, the patient felt full on body ache. She did not take any medication for her symptoms. All symptoms were still present at the time of reporting. No other treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: Very weak; Trouble breathing; Fever; Very nauseous; Shaky; Kind of dizzy; Bad headache; Muscle ache/ full on body ache; Fatigue (couldn't do anything but sit on the couch)/ very tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy) and HEADACHE (Bad headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced TREMOR (Shaky), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache) and FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired). 09-Mar-2021, the patient experienced DIZZINESS (Kind of dizzy). On 14-Mar-2021, the patient experienced DYSPNOEA (Trouble breathing), ASTHENIA (Very weak), PYREXIA (Fever) and NAUSEA (Very nauseous). At the time of the report, DYSPNOEA (Trouble breathing), TREMOR (Shaky), ASTHENIA (Very weak), DIZZINESS (Kind of dizzy), HEADACHE (Bad headache), MYALGIA (Muscle ache/ full on body ache), FATIGUE (Fatigue (couldn't do anything but sit on the couch)/ very tired), PYREXIA (Fever) and NAUSEA (Very nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  On 09-Mar-2021, the patient had muscle aches and on 14-Mar-2021, the patient felt full on body ache. She did not take any medication for her symptoms. All symptoms were still present at the time of reporting. No other treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included POTASSIUM, SIMVASTATIN and LOSARTAN for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient's HCP suggested that she should get the second shot in the opposite arm. The patient was also treated with heat pad.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dysarthria, Feeling abnormal, Headache, Memory impairment
Clinical narrative: Brain fog; Memory problems; Concentration; Hard to speak; Severe headaches; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak) and HEADACHE (Severe headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (in left eye). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), GABAPENTIN, LOSARTAN, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and PREDNISOLONE for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she seen a doctor and did some exercising for brain. The patient stated that she had surgery in left eye and believed that the medicine does not work well with the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Brain fog; Memory problems; Concentration; Hard to speak; Severe headaches; Muscle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak) and HEADACHE (Severe headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031I20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (in left eye). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), GABAPENTIN, LOSARTAN, ACETYLSALICYLIC ACID (BAYER ASPIRIN) and PREDNISOLONE for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), MEMORY IMPAIRMENT (Memory problems), DISTURBANCE IN ATTENTION (Concentration), DYSARTHRIA (Hard to speak), HEADACHE (Severe headaches) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she seen a doctor and did some exercising for brain. The patient stated that she had surgery in left eye and believed that the medicine does not work well with the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3 patients received the 2nd dose of the vaccine before 28 days; A spontaneous report was received from a nurse concerning three patients (age and gender unspecified) who received second dose of Moderna's COVID-19 vaccine (mRNA-1273), before the recommended window of 28 days, after 1st dose.  The patients' medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patients received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration and unknown arm, for prophylaxis of COVID-19 infection.  On an unspecified date, one patient received the second dose 14 days after the 1st dose and 2 patients received the second dose 20 days after the 1st dose (inappropriate schedule of vaccine administered).  No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the event of 3 patients received the 2nd dose of the vaccine before 28 days was considered as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold
Clinical narrative: Feeling cool / felt like 2-3 days after a cold; Very tired; Very minor chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills). At the time of the report, FEELING COLD (Feeling cool / felt like 2-3 days after a cold), FATIGUE (Very tired) and CHILLS (Very minor chills) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: lymph nodes changed( non specified); redness of injection side; swelling of injection side; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes changed( non specified)), INJECTION SITE ERYTHEMA (redness of injection side) and INJECTION SITE SWELLING (swelling of injection side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 15-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes changed( non specified)), INJECTION SITE ERYTHEMA (redness of injection side) and INJECTION SITE SWELLING (swelling of injection side). At the time of the report, LYMPHADENOPATHY (lymph nodes changed( non specified)), INJECTION SITE ERYTHEMA (redness of injection side) and INJECTION SITE SWELLING (swelling of injection side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising on the arm/ bruise spread to under arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising on the arm/ bruise spread to under arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (Bruising on the arm/ bruise spread to under arm). At the time of the report, CONTUSION (Bruising on the arm/ bruise spread to under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had bruising on the arm since 10-Mar-2021 and on 14-Mar-2021 it started spreading to his under arm. No treatment information was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Sleep disorder, Vaccination site erythema
Clinical narrative: Off and on they've been a little tired; started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching; woke up in the middle of the night scratching her right arm, couldn't stop scratching; It's a bit red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching), SLEEP DISORDER (woke up in the middle of the night scratching her right arm, couldn't stop scratching), VACCINATION SITE ERYTHEMA (It's a bit red) and FATIGUE (Off and on they've been a little tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching), SLEEP DISORDER (woke up in the middle of the night scratching her right arm, couldn't stop scratching) and VACCINATION SITE ERYTHEMA (It's a bit red). On an unknown date, the patient experienced FATIGUE (Off and on they've been a little tired). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) (topical) for Adverse event, at an unspecified dose and frequency. On 11-Mar-2021, PRURITUS (started itching, It was quite intense, it itched in their fingers, arms, the one that they had the shot was itching more than the other/ Chest was itching) and VACCINATION SITE ERYTHEMA (It's a bit red) had resolved. At the time of the report, SLEEP DISORDER (woke up in the middle of the night scratching her right arm, couldn't stop scratching) and FATIGUE (Off and on they've been a little tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was not taking any concomitant medications.   This case was linked to MOD-2021-246741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information included reporter contact information, treatment information, and new events added. The patient received 2nd vaccine on 28APR2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Vaccination site reaction
Clinical narrative: 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 ERYTHEMA (Bright red face) and FEELING HOT (Hot face/hot ears). On 09-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid-19 arm). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and HYDROCORTISONE at a dose of 1 dosage form. On 12-Mar-2021, VACCINATION SITE REACTION (Covid-19 arm) had resolved. At the time of the report, ERYTHEMA (Bright red face) outcome was unknown and FEELING HOT (Hot face/hot ears) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Headache; Nausea; Threw up some stomach bile; A little soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in my arm), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Threw up some stomach bile) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little soreness in my arm). On 15-Mar-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Threw up some stomach bile). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) on 15-Mar-2021 at a dose of UNK dosage form and PARACETAMOL (TYLENOL RAPID RELEASE GELS) at a dose of UNK dosage form. In March 2021, PAIN IN EXTREMITY (A little soreness in my arm) had resolved, NAUSEA (Nausea) was resolving, VOMITING (Threw up some stomach bile) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lyme disease.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (Lower back pain). At the time of the report, BACK PAIN (Lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  On 09-Mar-2021, the patient reported of having lower back pain. Reportedly, the patient had a prior history of Lymes disease.  No Concomitant product use was reported. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Gait disturbance, Headache, Histamine level
Clinical narrative: couldn't walk on that leg; head ache; flared up in the knee joint on the same leg as the arm that was inoculated; big red heated patch and itchy bumps under the skin; big red heated patch and itchy bumps under the skin; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't walk on that leg), ERYTHEMA (big red heated patch and itchy bumps under the skin), PRURITUS (big red heated patch and itchy bumps under the skin), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (big red heated patch and itchy bumps under the skin) and PRURITUS (big red heated patch and itchy bumps under the skin). On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't walk on that leg), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated). The patient was treated with NAPROXEN SODIUM (ALEVE) for Knee pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk on that leg), ERYTHEMA (big red heated patch and itchy bumps under the skin), PRURITUS (big red heated patch and itchy bumps under the skin), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Histamine level: high (High) Histamine level high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: couldn't walk on that leg; head ache; flared up in the knee joint on the same leg as the arm that was inoculated; big red heated patch and itchy bumps under the skin; big red heated patch and itchy bumps under the skin; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't walk on that leg), ERYTHEMA (big red heated patch and itchy bumps under the skin), PRURITUS (big red heated patch and itchy bumps under the skin), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (big red heated patch and itchy bumps under the skin) and PRURITUS (big red heated patch and itchy bumps under the skin). On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't walk on that leg), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated). The patient was treated with NAPROXEN SODIUM (ALEVE) for Knee pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk on that leg), ERYTHEMA (big red heated patch and itchy bumps under the skin), PRURITUS (big red heated patch and itchy bumps under the skin), HEADACHE (head ache) and ARTHRALGIA (flared up in the knee joint on the same leg as the arm that was inoculated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Histamine level: high (High) Histamine level high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Oedema peripheral, Peripheral swelling
Clinical narrative: Water retention and swelling in legs below knee; Water retention and swelling in legs below knee; Lower Limb Edema; This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema). At the time of the report, FLUID RETENTION (Water retention and swelling in legs below knee), PERIPHERAL SWELLING (Water retention and swelling in legs below knee) and OEDEMA PERIPHERAL (Lower Limb Edema) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Relevant concomitant medications included, medications for hypertension were reported.   Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Patient's contact details updated, newevent added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Numbness of tongue; Numbness of fingers and toes; Sweaty palms; Tingling of fingers and toes; Severe rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash). At the time of the report, HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received on 26-MAY-2021 and contact information was updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Numbness of tongue; Numbness of fingers and toes; Sweaty palms; Tingling of fingers and toes; Severe rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash). At the time of the report, HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness of fingers and toes), HYPERHIDROSIS (Sweaty palms), PARAESTHESIA (Tingling of fingers and toes) and RASH (Severe rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received on 26-MAY-2021 and contact information was updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Rush of a metallic taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Rush of a metallic taste in mouth) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (Rush of a metallic taste in mouth). At the time of the report, DYSGEUSIA (Rush of a metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medications were provided. The patient only had an egg and spinach that morning.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash macular, Swollen tongue
Clinical narrative: Swollen tongue; Swollen lip; Blotchy red; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red). At the time of the report, SWOLLEN TONGUE (Swollen tongue), LIP SWELLING (Swollen lip) and RASH MACULAR (Blotchy red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 at a dose of UNK dosage form. At the time of the report, HEADACHE (Headache) had not resolved.            Reportedly, the patient was taking concomitant medication (not specified). The patient took paracetamol, but it was not helpful.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Nausea, Pain
Clinical narrative: Chest pain; Pain (side pain, in their arm); Nausea; Headaches; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)), NAUSEA (Nausea) and HEADACHE (Headaches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Myeloma (Patient has cancer (myeloma) for the last 5 years. Patient go to chemotherapy once a month.) since 2016 and Hypertension.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headaches). On an unknown date, the patient experienced CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)) and NAUSEA (Nausea). At the time of the report, CHEST PAIN (Chest pain), PAIN (Pain (side pain, in their arm)), NAUSEA (Nausea) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant therapy included blood pressure medicine and chemotherapy.  Patient experienced headaches that seems to go and come back so patient does not know if it's side effect of the vaccine or the chemotherapy. Patient never had headache like that.  Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dizziness, Ear pain, Eye pain
Clinical narrative: Right arm started hurting too; Fast heartbeat; Pain went up into left ear; Eye began to hurt; Sore throat; Upset stomach; Shaking; Sweating; Dizziness; I couldn't function too good; Could not lift left arm; Pain across shoulders up into neck; I got a wicked headache; Feel like I have a temperature; Still feel a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt) and OROPHARYNGEAL PAIN (Sore throat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G4EA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (patient had heart surgery 5 years ago) in 2016.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache), PYREXIA (Feel like I have a temperature) and FATIGUE (Still feel a little tired). On 14-Mar-2021, PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache) and PYREXIA (Feel like I have a temperature) had resolved. At the time of the report, FATIGUE (Still feel a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not included  Action taken with mRNA-1273 in response to the event was unknown
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hyperhidrosis, Malaise
Clinical narrative: Right arm started hurting too; Fast heartbeat; Pain went up into left ear; Eye began to hurt; Sore throat; Upset stomach; Shaking; Sweating; Dizziness; I couldn't function too good; Could not lift left arm; Pain across shoulders up into neck; I got a wicked headache; Feel like I have a temperature; Still feel a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt) and OROPHARYNGEAL PAIN (Sore throat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G4EA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (patient had heart surgery 5 years ago) in 2016.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache), PYREXIA (Feel like I have a temperature) and FATIGUE (Still feel a little tired). On 14-Mar-2021, PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache) and PYREXIA (Feel like I have a temperature) had resolved. At the time of the report, FATIGUE (Still feel a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not included  Action taken with mRNA-1273 in response to the event was unknown
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Right arm started hurting too; Fast heartbeat; Pain went up into left ear; Eye began to hurt; Sore throat; Upset stomach; Shaking; Sweating; Dizziness; I couldn't function too good; Could not lift left arm; Pain across shoulders up into neck; I got a wicked headache; Feel like I have a temperature; Still feel a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt) and OROPHARYNGEAL PAIN (Sore throat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. G4EA21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (patient had heart surgery 5 years ago) in 2016.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache), PYREXIA (Feel like I have a temperature) and FATIGUE (Still feel a little tired). On 14-Mar-2021, PAIN IN EXTREMITY (Right arm started hurting too), HEART RATE INCREASED (Fast heartbeat), EAR PAIN (Pain went up into left ear), EYE PAIN (Eye began to hurt), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), MALAISE (I couldn't function too good), PAIN IN EXTREMITY (Could not lift left arm), ARTHRALGIA (Pain across shoulders up into neck), HEADACHE (I got a wicked headache) and PYREXIA (Feel like I have a temperature) had resolved. At the time of the report, FATIGUE (Still feel a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not included  Action taken with mRNA-1273 in response to the event was unknown
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Heart rate, Pyrexia, Tachycardia
Clinical narrative: Lowgrade fever; Chills; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), PYREXIA (Lowgrade fever) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LEVONORGESTREL (KYLEENA) for Birth control, VITAMIN C [ASCORBIC ACID] for Immune disorder (NOS), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Seasonal allergy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021 at 8:30 AM, the patient experienced TACHYCARDIA (Tachycardia). On an unknown date, the patient experienced PYREXIA (Lowgrade fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, TACHYCARDIA (Tachycardia) had resolved. At the time of the report, PYREXIA (Lowgrade fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Heart rate: 140 (High) heart rate remained high for about 15 hours..         Treatment included  fluids. Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-044470 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 7-Jun-2021, reporter details, patient demographics, patient date of birth, concomitant medications, event (tachycardia) start date, stop date were added. Outcome for the event tachycardia was updated to recovered from unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia
Clinical narrative: Spike in sugars; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Spike in sugars) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HYPERGLYCAEMIA (Spike in sugars). At the time of the report, HYPERGLYCAEMIA (Spike in sugars) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood glucose: high (High) Sugar level spiked.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient ate greens as treatment.