chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Hypokinesia
Clinical narrative: upper part of my stomach decided hurting, excruciating pain; I can hardly move; fatigue; terrible headache; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (upper part of my stomach decided hurting, excruciating pain), HYPOKINESIA (I can hardly move), FATIGUE (fatigue) and HEADACHE (terrible headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 DIARRHOEA (diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (upper part of my stomach decided hurting, excruciating pain), HYPOKINESIA (I can hardly move), FATIGUE (fatigue) and HEADACHE (terrible headache). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (upper part of my stomach decided hurting, excruciating pain), HYPOKINESIA (I can hardly move), FATIGUE (fatigue) and HEADACHE (terrible headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment for the event includes drank some of that pink stuff.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (circular rash at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.  No Medical History information was reported. On 16-Feb-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 PRURITUS (itchy) and VACCINATION SITE RASH (circular rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (circular rash at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side Effects hit him like a ton of bricks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side Effects hit him like a ton of bricks) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Side Effects hit him like a ton of bricks). At the time of the report, VACCINATION COMPLICATION (Side Effects hit him like a ton of bricks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Attached Telephone Contact Report. Contains no new information. On 15-Jul-2021: updated reporter contact details.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid dermatopathy.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes: High blood pressure medication and thyroid medication   This case was linked to MOD21-028591 (E2B Linked Report).; Sender's Comments:  MOD21-028591:CROSS LINKED NO
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Sore Throat; Pain at injection site (LEFT); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), VACCINATION SITE PAIN (Pain at injection site (LEFT)) and FATIGUE (Fatigue) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder and Anemia. Concomitant products included RIVAROXABAN (XARELTO) and IRON for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), VACCINATION SITE PAIN (Pain at injection site (LEFT)) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE SULFATE (CORICIDIN D COLD FLU AND SINUS) at an unspecified dose and frequency. On 26-Jan-2021, OROPHARYNGEAL PAIN (Sore Throat) had resolved. On 28-Jan-2021, VACCINATION SITE PAIN (Pain at injection site (LEFT)) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient skipped dose of Xarelto on 1MARCH2021 and 2MARCH2021 (before and day of vaccination) without recommendation of HCP.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 33-year-old, pregnant female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)/exposure during pregnancy.  The patient's medical history, as provided by the reporter, included gestational diabetes, alcohol use, subfertility (possible progesterone deficiency), breech delivery and c-section. The patient had four prior pregnancies. First and second pregnancy resulted in spontaneous abortion. The third pregnancy ended on date with a live full-term birth through breech, c-section. The fourth pregnancy ended on date with a live full-term birth through c-section. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and progesterone.   On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 025J202A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient received a positive pregnancy test. Patient's last menstrual period was on 21 Jan 2021 and estimated conception date was on 30 Jan 2021. The patient's estimated due date is date.  On 01 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. Patient would like to be enrolled into the pregnancy registry. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, exposure to moderna vaccine during pregnancy, was considered resolved on 01 Feb 2021.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Inflammation, Peripheral swelling, Pruritus, Rash
Clinical narrative: Itchy sensation all over body where there was welts and swelling; burning sensation all over body where there was welts and swelling; Welts turned into rashes; Welts all over the body; Swollen toes and feet; Whole right side became inflamed; Rash on right and left shoulder; A spontaneous report was received from a consumer concerning herself, who is a 39-years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events whole right side became inflamed, rash on right and left shoulder, welts all over the body, swollen toes and feet, itchy sensation all over body where there was welts and swelling, burning sensation all over body where there was welts and swelling, welts turned into rashes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received a doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events whole right side became inflamed, rash on right and left shoulder on 17 Feb 2021, on  18 Feb 201 welts all over body, swollen toes and feet, itchy burning sensation all over body where there was welts and swelling, welts turned into rashes.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events whole right side became inflamed, rash on right and left shoulder, welts all over the body, swollen toes and feet, itchy sensation all over body where there was welts and swelling, burning sensation all over body where there was welts and swelling, welts turned into rashes was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy sensation all over body where there was welts and swelling; burning sensation all over body where there was welts and swelling; Welts turned into rashes; Welts all over the body; Swollen toes and feet; Whole right side became inflamed; Rash on right and left shoulder; A spontaneous report was received from a consumer concerning herself, who is a 39-years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events whole right side became inflamed, rash on right and left shoulder, welts all over the body, swollen toes and feet, itchy sensation all over body where there was welts and swelling, burning sensation all over body where there was welts and swelling, welts turned into rashes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received a doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the events whole right side became inflamed, rash on right and left shoulder on 17 Feb 2021, on  18 Feb 201 welts all over body, swollen toes and feet, itchy burning sensation all over body where there was welts and swelling, welts turned into rashes.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events whole right side became inflamed, rash on right and left shoulder, welts all over the body, swollen toes and feet, itchy sensation all over body where there was welts and swelling, burning sensation all over body where there was welts and swelling, welts turned into rashes was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling hot, Headache
Clinical narrative: lost 7 pound; Lost appetite; has fluid in ears; feels hot; fatigue; Chills; Headache; A spontaneous report was received from a consumer concerning a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills, fatigue, feels hot, lost appetite, has fluid in ears, lost 7 pound.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) headache, chills, fatigue, feels hot, lost appetite, has fluid in ears. On 1 Mar 2021, the patient experienced the event(s) lost 7 pound.  Treatment details included prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, chills, fatigue, feels hot, lost appetite, has fluid in ears, lost 7 pound was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Otorrhoea, Weight decreased
Clinical narrative: lost 7 pound; Lost appetite; has fluid in ears; feels hot; fatigue; Chills; Headache; A spontaneous report was received from a consumer concerning a 41-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills, fatigue, feels hot, lost appetite, has fluid in ears, lost 7 pound.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) headache, chills, fatigue, feels hot, lost appetite, has fluid in ears. On 1 Mar 2021, the patient experienced the event(s) lost 7 pound.  Treatment details included prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, chills, fatigue, feels hot, lost appetite, has fluid in ears, lost 7 pound was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: A spontaneous report was received from a nurse concerning a 47-year-old, male patient, received the 1st Moderna Vaccine on 01 Feb 2021, today the patient received the Pfizer vaccine (Wrong vaccine administered ). The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported. On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 043L20A) for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient inadvertently received the Pfizer vaccine (Wrong vaccine administered ). Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, Wrong vaccine administered was considered resolved.; Reporter's Comments: This report refers to a case of Wrong product administered of for mRNA-1273, the patient received the Pfizer vaccine, with no associated AEs.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itches; started to experience swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), SWELLING (started to experience swelling) and ERYTHEMA (Redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (Itches), SWELLING (started to experience swelling) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itches), SWELLING (started to experience swelling) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: both of her shoulders had knives in them(pain); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (both of her shoulders had knives in them(pain)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004M20a) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MELOXICAM (MOBIC), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ESTRADIOL (ESTROGEN), COLECALCIFEROL (VITAMIN D 3), ASCORBIC ACID (VITAMIN C ACID), FISH OIL and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced ARTHRALGIA (both of her shoulders had knives in them(pain)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (both of her shoulders had knives in them(pain)) outcome was unknown.            Treatment Medicines include Tylenol and Mobic that patient takes for Arthritis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Prolonged redness on the arm; A spontaneous report was received from a consumer concerning a 82-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site erythema (prolonged redness on the arm).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced red at the site of injection and stated that after 3 days od vaccination redness is still there.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, prolonged redness on the arm was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: feel dizzy; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy) and NAUSEA (nauseous) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (feel dizzy) and NAUSEA (nauseous). At the time of the report, DIZZINESS (feel dizzy) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: in the Neck (From Shoulder blade to neck and chin); Swelling opposite hand; A spontaneous report was received from a consumer concerning herself, who is a 80-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling in the neck (from shoulder blade to neck and chin), swelling opposite hand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the events swelling in the neck (from shoulder blade to neck and chin) and opposite hand (not the injected arm/hand).  Treatment information was not provided.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable  The outcome of events swelling in the neck (from shoulder blade to neck and chin), swelling opposite hand was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity, Rash pruritic
Clinical narrative: sore arm (side of the injection); itchy rashes; could not lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm (side of the injection)), HYPOKINESIA (could not lift her arm) and RASH PRURITIC (itchy rashes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPOKINESIA (could not lift her arm). On 09-Feb-2021, the patient experienced RASH PRURITIC (itchy rashes). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm (side of the injection)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 09-Feb-2021, PAIN IN EXTREMITY (sore arm (side of the injection)) and HYPOKINESIA (could not lift her arm) had resolved. At the time of the report, RASH PRURITIC (itchy rashes) outcome was unknown. Not Provided      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 19-Jun-2021: Non significant follow up received on 19-JUN-2021, no new information
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Fever - Temperature of 100.1F; Muscle Pain; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 100.1F), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 100.1F), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever - Temperature of 100.1F), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Pyrexia: 100.1 Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Little Dizzines; Headache; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Little Dizzines) and HEADACHE (Headache) in a 74-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 No adverse event. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), ATORVASTATIN CALCIUM (LIPITOR), ALENDRONATE SODIUM (FOSAMAX), LEVOTHYROXINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN LOW), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication, LISINOPRIL.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (Little Dizzines) and HEADACHE (Headache). At the time of the report, DIZZINESS (Little Dizzines) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: missed period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (missed period) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (missed period). At the time of the report, MENSTRUATION DELAYED (missed period) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID positive; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID positive) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 antibody test: positive Positive.     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.   No concomitant medication were reported No treatment medication were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Lip swelling
Clinical narrative: Patient having breathing problems after injection; Chest tightening after injection; Upper lip swelling; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Patient having breathing problems after injection), CHEST DISCOMFORT (Chest tightening after injection) and LIP SWELLING (Upper lip swelling) 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 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Patient having breathing problems after injection), CHEST DISCOMFORT (Chest tightening after injection) and LIP SWELLING (Upper lip swelling). At the time of the report, DYSPNOEA (Patient having breathing problems after injection), CHEST DISCOMFORT (Chest tightening after injection) and LIP SWELLING (Upper lip swelling) 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 product information was not provided. Treatment medication was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20-JUL-2021 and contains Non-significant information
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: ache; chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 PAIN (ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain of skin, Paraesthesia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Tingling in her hands, little prickling), PAIN (Little stings), HYPOAESTHESIA (Numbness in both her hands but more so in her right hand), PAIN OF SKIN (Feels this in other parts of her body especially her legs, across her shoulders, and up into her scalp) and PAIN (After getting the vaccine it's as if those sensations have been exacerbated and gotten worse by the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling in her hands, little prickling), PAIN (Little stings), HYPOAESTHESIA (Numbness in both her hands but more so in her right hand), PAIN OF SKIN (Feels this in other parts of her body especially her legs, across her shoulders, and up into her scalp) and PAIN (After getting the vaccine it's as if those sensations have been exacerbated and gotten worse by the vaccine). At the time of the report, PARAESTHESIA (Tingling in her hands, little prickling), PAIN (Little stings), HYPOAESTHESIA (Numbness in both her hands but more so in her right hand), PAIN OF SKIN (Feels this in other parts of her body especially her legs, across her shoulders, and up into her scalp) and PAIN (After getting the vaccine it's as if those sensations have been exacerbated and gotten worse by the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment details were not provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: At injection site: red, hard, itchy, hot, raised skin roughly 4 inches in diameter began to appear with 18 hours of receiving the injection. Wednesday, August 11th at around 4pm was when I received the vaccine. I noticed this thing on my arm the next day around 1pm. It?s gotten bigger, more red, and more itchy. It is still going strong Sunday morning at 3:15?.3 1/2 days after receiving the vaccine. Benadryl nor ibuprofen seem to help much but cold feels wonderful. So does lightly scratching it.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: At injection site: red, hard, itchy, hot, raised skin roughly 4 inches in diameter began to appear with 18 hours of receiving the injection. Wednesday, August 11th at around 4pm was when I received the vaccine. I noticed this thing on my arm the next day around 1pm. It?s gotten bigger, more red, and more itchy. It is still going strong Sunday morning at 3:15?.3 1/2 days after receiving the vaccine. Benadryl nor ibuprofen seem to help much but cold feels wonderful. So does lightly scratching it.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Burning sensation, Chest discomfort, Dyspnoea, Feeling abnormal
Clinical narrative: A burning strange sensation moving to my neck. Shortness of breath, numb sensation down both right and left arms, numbness in fingers on right arm  especially right first digit, fourth and fifth digit. I had strange tightness in my chest, feeling very short of breath. On the way home I kept having arrhythmia and it is 1:23AM on 6/15/21a and I still feel awful and cannot sleep.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia
Clinical narrative: A burning strange sensation moving to my neck. Shortness of breath, numb sensation down both right and left arms, numbness in fingers on right arm  especially right first digit, fourth and fifth digit. I had strange tightness in my chest, feeling very short of breath. On the way home I kept having arrhythmia and it is 1:23AM on 6/15/21a and I still feel awful and cannot sleep.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Choking sensation, Dyspnoea, Tachycardia
Clinical narrative: Chest pain and choking sensation or mild asthma or dyspnea and sometimes tachycardia.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Low fever; achy; pretty bad arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low fever), MYALGIA (achy) and PAIN IN EXTREMITY (pretty bad arm pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L26A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 PYREXIA (Low fever), MYALGIA (achy) and PAIN IN EXTREMITY (pretty bad arm pain). At the time of the report, PYREXIA (Low fever), MYALGIA (achy) and PAIN IN EXTREMITY (pretty bad arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication is not provided. Treatment information include Advil.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, Pain in extremity. The patient's medical history included high cholesterol and hypertension. Concomitant medications reported were rosuvastatin To treat high cholesterol, carvedilol To treat high blood pressure. On 1 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 1 Mar 2021, the patient experienced the event, a little minimal soreness in the left arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of event, a little minimal soreness in the left arm, was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Headache, Hypokinesia
Clinical narrative: flu-like symptoms; stomachache; body ache; headache; chills; left arm of injection ache; chest like bandore; left arm of injection warm; left arm of injection barely can move it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHEST DISCOMFORT (chest like bandore) and ABDOMINAL PAIN UPPER (stomachache) in a 66-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.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), CHEST DISCOMFORT (chest like bandore) and VACCINATION SITE PAIN (left arm of injection ache). On 10-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHEST DISCOMFORT (chest like bandore), ABDOMINAL PAIN UPPER (stomachache), VACCINATION SITE PAIN (left arm of injection ache), MYALGIA (body ache), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Vaccination site pain, Vaccination site warmth
Clinical narrative: flu-like symptoms; stomachache; body ache; headache; chills; left arm of injection ache; chest like bandore; left arm of injection warm; left arm of injection barely can move it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHEST DISCOMFORT (chest like bandore) and ABDOMINAL PAIN UPPER (stomachache) in a 66-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.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), CHEST DISCOMFORT (chest like bandore) and VACCINATION SITE PAIN (left arm of injection ache). On 10-Feb-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (stomachache), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (left arm of injection warm), HYPOKINESIA (left arm of injection barely can move it), INFLUENZA LIKE ILLNESS (flu-like symptoms), CHEST DISCOMFORT (chest like bandore), ABDOMINAL PAIN UPPER (stomachache), VACCINATION SITE PAIN (left arm of injection ache), MYALGIA (body ache), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, SARS-CoV-2 antibody test
Clinical narrative: Non-reactive results for IgG antibodies; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST NEGATIVE (Non-reactive results for IgG antibodies) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ANTIBODY TEST NEGATIVE (Non-reactive results for IgG antibodies). On 26-Jan-2021, ANTIBODY TEST NEGATIVE (Non-reactive results for IgG antibodies) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided  Very limited information has been provided for the event at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Report provided; Sender's Comments: Very limited information has been provided for the event at this time. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Exposure during pregnancy, Ultrasound scan, Vaccination site pain
Clinical narrative: vaccination site pain; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 44-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.    The patient's past medical history included Miscarriage in November 2017 and Allergy (decrease injections) since 01-Jan-2017. Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for Deficiency vitamin, PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for Pregnancy.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-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 22-May-2021. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound scan: normal (normal) healthy. On 27-Feb-2021, COVID-19: positive (Positive) Tested positive. In 2021, Blood glucose: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported 3 previous pregnancies included first on 16-Sep-2016 with outcome of live full- term birth, for second miscarriage had happened in Nov-2017 and third on 09-Aug-2019 with the outcome of live full-term birth.  Estimated date of conception reported was 15-Aug-2020. Date of positive pregnancy test was 15-Oct-2020.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Rhinorrhoea
Clinical narrative: Sore arm; Little stiffness of the neck; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Little stiffness of the neck) and RHINORRHOEA (Runny nose) in a 75-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Little stiffness of the neck) and RHINORRHOEA (Runny nose). At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Little stiffness of the neck) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Had ringing in her ears; Has trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Had ringing in her ears) and INSOMNIA (Has trouble sleeping) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced TINNITUS (Had ringing in her ears) and INSOMNIA (Has trouble sleeping). At the time of the report, TINNITUS (Had ringing in her ears) and INSOMNIA (Has trouble sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Spots at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Spots at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATENOLOL, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (LIOTHYRONIN) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 VACCINATION SITE URTICARIA (Spots at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Spots at the injection site) outcome was unknown.            No treatment information was provided.