chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Headache, Nausea
Clinical narrative: Back pain; Nausea; Painful headache; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), BACK PAIN (Back pain), NAUSEA (Nausea) and HEADACHE (Painful headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (Dizzy), NAUSEA (Nausea) and HEADACHE (Painful headache). On 24-Feb-2021, the patient experienced BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) for Dizzy, Nausea, Headache and Back pain, at a dose of UNK dosage form and IBUPROFEN for Dizzy, Nausea, Headache and Back pain, at a dose of UNK dosage form. At the time of the report, DIZZINESS (Dizzy), BACK PAIN (Back pain), NAUSEA (Nausea) and HEADACHE (Painful headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination complication
Clinical narrative: not able to keep anything down; extreme nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not able to keep anything down) and NAUSEA (extreme nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (not able to keep anything down) and NAUSEA (extreme nausea). The patient was treated with GLUCOSE, POTASSIUM CITRATE, SODIUM CHLORIDE (PEDIALYTE 30) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (not able to keep anything down) and NAUSEA (extreme nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: He has stayed in bed most of the time since yesterday at 2 pm; Very little appetite; Fever (99.5-100.5); Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He has stayed in bed most of the time since yesterday at 2 pm), DECREASED APPETITE (Very little appetite), PYREXIA (Fever (99.5-100.5)) and MYALGIA (Muscle ache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (He has stayed in bed most of the time since yesterday at 2 pm), DECREASED APPETITE (Very little appetite), PYREXIA (Fever (99.5-100.5)) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, VACCINATION COMPLICATION (He has stayed in bed most of the time since yesterday at 2 pm), DECREASED APPETITE (Very little appetite), PYREXIA (Fever (99.5-100.5)) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 99.5-100.5 (High) 99.5-100.5. On 24-Feb-2021, Body temperature: 99.5 (High) in the morning.         Concomitant medication was not included.  The patient took Tylenol which helped a little bit but it was not a game changer.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Arm Pain; Swollen Lymph Nodes; Fever - Temperature as high as 101.0F; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever - Temperature as high as 101.0F) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever - Temperature as high as 101.0F) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Swollen lymph nodes, Pain in arm, Fever and Fatigue, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Swollen lymph nodes, Pain in arm, Fever and Fatigue, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm Pain), LYMPHADENOPATHY (Swollen Lymph Nodes), PYREXIA (Fever - Temperature as high as 101.0F) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101.0 (High) 101.0 F.     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.   Concomitant medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and HEADACHE (Headache) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, MYALGIA (Body ache) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tingling on a spot on lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling on a spot on lip) 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 Blister of lip (getting blister on lip if while staying out in the sun without sunscreen.).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling on a spot on lip). At the time of the report, PARAESTHESIA ORAL (tingling on a spot on lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Stiffness of the arm of the injection; Fever; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Stiffness of the arm of the injection), PYREXIA (Fever), PAIN (Body ache) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Stiffness of the arm of the injection), PYREXIA (Fever), PAIN (Body ache) and HEADACHE (Headache). The patient was treated with TRAMADOL at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Stiffness of the arm of the injection), PYREXIA (Fever), PAIN (Body ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Pulmonary pain, Sinus headache
Clinical narrative: her head is bothering her; pain in her arm for three days that made her shoulder hurt and even her lung; pain in lung; shoulder hurt; Mild headache; This spontaneous case was reported by a patient and describes the occurrence of SINUS HEADACHE (her head is bothering her), PAIN IN EXTREMITY (pain in her arm for three days that made her shoulder hurt and even her lung), PULMONARY PAIN (pain in lung), ARTHRALGIA (shoulder hurt) and HEADACHE (Mild headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ear discomfort and Sinusitis.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (pain in her arm for three days that made her shoulder hurt and even her lung), PULMONARY PAIN (pain in lung), ARTHRALGIA (shoulder hurt) and HEADACHE (Mild headache). On 24-Feb-2021, the patient experienced SINUS HEADACHE (her head is bothering her). In February 2021, PAIN IN EXTREMITY (pain in her arm for three days that made her shoulder hurt and even her lung) had resolved. At the time of the report, SINUS HEADACHE (her head is bothering her), PULMONARY PAIN (pain in lung), ARTHRALGIA (shoulder hurt) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. On 13-FEB-2021, the patient went to the physician because her ear was bothering her and was prescribed amoxicillin antibiotic. She did not take it because the next day she had to get the vaccinated. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound foetal
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included In vitro fertilisation. Previously administered products included for an unreported indication: ALCOHOL (5 drinks/ week socially.) from 22-Dec-2008 to 01-Sep-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 25-Aug-2020 to 17-May-2021, ACETYLSALICYLIC ACID (BABY ASPIRIN), PROGESTERONE from 13-Sep-2020 to 07-Nov-2020, ESTRADIOL (ESTROGEN) from 24-Aug-2020 to an unknown date, ESTRADIOL (ESTROGEN) from 04-Sep-2020 to an unknown date and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 08-Dec-2020 to an unknown date for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 05-Jun-2021. On 24-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 24-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2020, Pregnancy test: Positive. On 19-Oct-2020, Ultrasound foetal: normal. On 24-Oct-2020, Ultrasound foetal: normal. On 25-Nov-2020, Prenatal screening test: normal. On 25-Nov-2020, Ultrasound foetal: normal. On 20-Jan-2021, Ultrasound foetal: normal.     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.   Patient had a positive pregnancy test on 22 Sep 2020. Her last menstrual period was 1 Aug 2020 and estimated date of conception was 12 Sep 2020.Patient had a missed pregnancy on 12 Oct 2019.  Patient's medical history include unexplained infertility , unsuccessful medicated / monitored aids followed by successful IVF.  Family history include down syndrome for the father's sister.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Patient demography , medical history , lab data and concomitant medications information were updated.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Decreased appetite, Dehydration
Clinical narrative: FEVER; DIZZINESS; HE IS SO DIZZY THAT HE FELL AND HIT HEAD; dehydrated; Loss of taste; loss of smell; COULDN'T EAT NOR DRINK FOR SOME DAYS; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD) and DEHYDRATION (dehydrated) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD), DEHYDRATION (dehydrated), AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (COULDN'T EAT NOR DRINK FOR SOME DAYS). The patient was treated with NORMAL SALINE at an unspecified dose and frequency and CALCIUM ASCORBATE, MAGNESIUM GLUCONATE, MAGNESIUM LACTATE, POTASSIUM CITRATE (ELECTROLYTE + C) at an unspecified dose and frequency. At the time of the report, CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD), DEHYDRATION (dehydrated), AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (COULDN'T EAT NOR DRINK FOR SOME DAYS) outcome was unknown.            This case was linked to MOD21-037815 (Patient Link).
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Pyrexia
Clinical narrative: FEVER; DIZZINESS; HE IS SO DIZZY THAT HE FELL AND HIT HEAD; dehydrated; Loss of taste; loss of smell; COULDN'T EAT NOR DRINK FOR SOME DAYS; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD) and DEHYDRATION (dehydrated) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD), DEHYDRATION (dehydrated), AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (COULDN'T EAT NOR DRINK FOR SOME DAYS). The patient was treated with NORMAL SALINE at an unspecified dose and frequency and CALCIUM ASCORBATE, MAGNESIUM GLUCONATE, MAGNESIUM LACTATE, POTASSIUM CITRATE (ELECTROLYTE + C) at an unspecified dose and frequency. At the time of the report, CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD), DEHYDRATION (dehydrated), AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (COULDN'T EAT NOR DRINK FOR SOME DAYS) outcome was unknown.            This case was linked to MOD21-037815 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site became hard; injection site was sore; Feverish; the injection site became red/it was still red 4 to 5 inches in diameter; injection site became swollen, and got worst by February 7th.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE ERYTHEMA (the injection site became red/it was still red 4 to 5 inches in diameter), VACCINATION SITE SWELLING (injection site became swollen, and got worst by February 7th.), VACCINATION SITE PAIN (injection site was sore) and PYREXIA (Feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (the injection site became red/it was still red 4 to 5 inches in diameter) and VACCINATION SITE SWELLING (injection site became swollen, and got worst by February 7th.). On 07-Feb-2021, the patient experienced VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE PAIN (injection site was sore) and PYREXIA (Feverish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Feb-2021 for Vaccination site induration, Vaccination site erythema, Vaccination site swelling, Vaccination site pain and Feverish, at a dose of UNK dosage form and PARACETAMOL (TYLENOL EXTRA STRENGTH) for Vaccination site induration, Vaccination site erythema, Vaccination site swelling, Vaccination site pain and Feverish, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE INDURATION (injection site became hard), VACCINATION SITE ERYTHEMA (the injection site became red/it was still red 4 to 5 inches in diameter), VACCINATION SITE SWELLING (injection site became swollen, and got worst by February 7th.), VACCINATION SITE PAIN (injection site was sore) and PYREXIA (Feverish) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment also included a prescription cream (topical) and it started to improve over night.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Muscular weakness
Clinical narrative: numbness in toes; minor weakness in legs; minor low back aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in toes), MUSCULAR WEAKNESS (minor weakness in legs) and BACK PAIN (minor low back aches) in a 56-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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in toes), MUSCULAR WEAKNESS (minor weakness in legs) and BACK PAIN (minor low back aches). At the time of the report, HYPOAESTHESIA (numbness in toes), MUSCULAR WEAKNESS (minor weakness in legs) and BACK PAIN (minor low back aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Headache, Myalgia, Pain
Clinical narrative: cellulitis; Pain; rash trunk; temperature of 99.5 degrees F; muscle pain; joint pain; massive lump on shoulder big as a grapefruit; itching really bad; Massive Headache; vaccination site erythema; A spontaneous report was received from a consumer,  concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, itching really bad/injection site pruritus, muscle pain/myalgia, joint pain/arthralgia, massive great fruit sized lump/injection site lump, temperature of 99.5 degrees/pyrexia, and massive headache.  The patient's medical history was not reported. No Relevant concomitant medications were reported like  On 18JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On date 18JAN2021, The patient experienced a massive lump on shoulder big as a grapefruit, rash under his chest and arm, major red skin under the arm, temperature of 99.5 degrees F, muscle pain, joint pain, felt like shingles, burning skin, itching really bad, cellulitis, scalded.   Laboratory details not provided.    Treatment information was provided : cephalexin 500mg three times a day for 7 days lidocaine 5% ointment twice a day for 7 days triamcinolone acetate 0.5% twice a day if needed for 7 days naproxen 250 mg twice a day  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events were all recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site cellulitis, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: cellulitis; Pain; rash trunk; temperature of 99.5 degrees F; muscle pain; joint pain; massive lump on shoulder big as a grapefruit; itching really bad; Massive Headache; vaccination site erythema; A spontaneous report was received from a consumer,  concerning a male patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, itching really bad/injection site pruritus, muscle pain/myalgia, joint pain/arthralgia, massive great fruit sized lump/injection site lump, temperature of 99.5 degrees/pyrexia, and massive headache.  The patient's medical history was not reported. No Relevant concomitant medications were reported like  On 18JAN2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On date 18JAN2021, The patient experienced a massive lump on shoulder big as a grapefruit, rash under his chest and arm, major red skin under the arm, temperature of 99.5 degrees F, muscle pain, joint pain, felt like shingles, burning skin, itching really bad, cellulitis, scalded.   Laboratory details not provided.    Treatment information was provided : cephalexin 500mg three times a day for 7 days lidocaine 5% ointment twice a day for 7 days triamcinolone acetate 0.5% twice a day if needed for 7 days naproxen 250 mg twice a day  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events were all recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Swollen tongue
Clinical narrative: itching from scalp to legs; tongue and lip swelled; tongue and lip swelled; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching from scalp to legs), SWOLLEN TONGUE (tongue and lip swelled) and LIP SWELLING (tongue and lip swelled) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching from scalp to legs), SWOLLEN TONGUE (tongue and lip swelled) and LIP SWELLING (tongue and lip swelled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching all over, Tongue swelling non-specific and Lip swelling, at a dose of UNK dosage form. At the time of the report, PRURITUS (itching from scalp to legs), SWOLLEN TONGUE (tongue and lip swelled) and LIP SWELLING (tongue and lip swelled) 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.   Concomitant medication was not reported.  The physician reported that the itching from scalp to legs did not break out in a rash.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Nausea, Urticaria, Vaccination site erythema
Clinical narrative: Warmness at the injection site; Hives at top torso; Headache; Nausea; Swelling at the injection site; Turned red at injection site; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (uncomfortable), VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache) and NAUSEA (Nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DISCOMFORT (uncomfortable). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Turned red at injection site). At the time of the report, DISCOMFORT (uncomfortable), VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Turned red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmness at the injection site; Hives at top torso; Headache; Nausea; Swelling at the injection site; Turned red at injection site; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (uncomfortable), VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache) and NAUSEA (Nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DISCOMFORT (uncomfortable). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Turned red at injection site). At the time of the report, DISCOMFORT (uncomfortable), VACCINATION SITE WARMTH (Warmness at the injection site), URTICARIA (Hives at top torso), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Turned red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: tender to the touch; swollen; hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (tender to the touch) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Drug addiction. Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Hypertension.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (tender to the touch). At the time of the report, VACCINATION SITE SWELLING (swollen), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PAIN (tender to the touch) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Insomnia
Clinical narrative: can't drive because feels weak/weakness; can't drive because she feels dizzy/dizziness; tossing and turning and cannot sleep on her left side; nausea; chills; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 029L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease. Concomitant products included VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue). At the time of the report, ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown.            Concomitant medication included thyroid pill every morning for Graves disease.  The patient did not take any treatment medication. The patient usually was very healthy and active.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: can't drive because feels weak/weakness; can't drive because she feels dizzy/dizziness; tossing and turning and cannot sleep on her left side; nausea; chills; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea) and CHILLS (chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 029L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease. Concomitant products included VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue). At the time of the report, ASTHENIA (can't drive because feels weak/weakness), DIZZINESS (can't drive because she feels dizzy/dizziness), INSOMNIA (tossing and turning and cannot sleep on her left side), NAUSEA (nausea), CHILLS (chills), VACCINATION SITE PAIN (sore arm) and FATIGUE (fatigue) outcome was unknown.            Concomitant medication included thyroid pill every morning for Graves disease.  The patient did not take any treatment medication. The patient usually was very healthy and active.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at injection site; Redness at injection site; swollen at injection site; feverish (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (swollen at injection site) and PYREXIA (feverish (at injection site)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (swollen at injection site) and PYREXIA (feverish (at injection site)). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (swollen at injection site) and PYREXIA (feverish (at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Muscle spasms, Pain
Clinical narrative: neck popping; ache neck and scull; dizziness; headache; fatigue; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (neck popping), PAIN (ache neck and scull), DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (Pain at injection site). On 21-Feb-2021, the patient experienced PAIN (ache neck and scull). On 23-Feb-2021, the patient experienced MUSCLE SPASMS (neck popping). On 21-Feb-2021, HEADACHE (headache) had resolved. On 23-Feb-2021, MUSCLE SPASMS (neck popping) had resolved. On 24-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PAIN (ache neck and scull), DIZZINESS (dizziness) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: neck popping; ache neck and scull; dizziness; headache; fatigue; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (neck popping), PAIN (ache neck and scull), DIZZINESS (dizziness), HEADACHE (headache) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (Pain at injection site). On 21-Feb-2021, the patient experienced PAIN (ache neck and scull). On 23-Feb-2021, the patient experienced MUSCLE SPASMS (neck popping). On 21-Feb-2021, HEADACHE (headache) had resolved. On 23-Feb-2021, MUSCLE SPASMS (neck popping) had resolved. On 24-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PAIN (ache neck and scull), DIZZINESS (dizziness) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: black and blue mark at the injection site/The mark is about a 2 inch diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (black and blue mark at the injection site/The mark is about a 2 inch diameter) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (black and blue mark at the injection site/The mark is about a 2 inch diameter). At the time of the report, VACCINATION SITE DISCOLOURATION (black and blue mark at the injection site/The mark is about a 2 inch diameter) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received first dose on 16-Feb-2021 at 12:00 in left arm shoulder deltoid muscle.  Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Significant TCR report received, Reporter's email address added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: dizzy/woozy; nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), DIZZINESS (dizzy/woozy) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (sore arm). On 02-Feb-2021, the patient experienced DIZZINESS (dizzy/woozy) and NAUSEA (nausea). On 21-Jan-2021, PAIN (sore arm) had resolved. At the time of the report, DIZZINESS (dizzy/woozy) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR on 25-MAY-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not reported. Treatment medication was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Feeling abnormal, Pain, Speech disorder
Clinical narrative: seemed confused; difficulty speaking; little achiness; tired; no sound normal; little sore at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (no sound normal), CONFUSIONAL STATE (seemed confused), SPEECH DISORDER (difficulty speaking), PAIN (little achiness) and FATIGUE (tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included Levotyrixine and ATORVASTATIN for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (little sore at the injection site). On 23-Feb-2021, the patient experienced FEELING ABNORMAL (no sound normal), PAIN (little achiness) and FATIGUE (tired). On an unknown date, the patient experienced CONFUSIONAL STATE (seemed confused) and SPEECH DISORDER (difficulty speaking). At the time of the report, FEELING ABNORMAL (no sound normal), CONFUSIONAL STATE (seemed confused), SPEECH DISORDER (difficulty speaking), PAIN (little achiness), FATIGUE (tired) and VACCINATION SITE PAIN (little sore at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: seemed confused; difficulty speaking; little achiness; tired; no sound normal; little sore at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (no sound normal), CONFUSIONAL STATE (seemed confused), SPEECH DISORDER (difficulty speaking), PAIN (little achiness) and FATIGUE (tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included Levotyrixine and ATORVASTATIN for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (little sore at the injection site). On 23-Feb-2021, the patient experienced FEELING ABNORMAL (no sound normal), PAIN (little achiness) and FATIGUE (tired). On an unknown date, the patient experienced CONFUSIONAL STATE (seemed confused) and SPEECH DISORDER (difficulty speaking). At the time of the report, FEELING ABNORMAL (no sound normal), CONFUSIONAL STATE (seemed confused), SPEECH DISORDER (difficulty speaking), PAIN (little achiness), FATIGUE (tired) and VACCINATION SITE PAIN (little sore at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.