chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Vaccination complication
Clinical narrative: side effects after the second/ felt those were similar to the second shot reaction; night sweating/We felt those were similar to the second shot reaction; increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction; Chest pain on left side; Joint pain/We felt those were similar to the second shot reaction; aching everywhere/We felt those were similar to the second shot reaction; Fever/We felt those were similar to the second shot reaction; chills/We felt those were similar to the second shot reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), CHEST PAIN (Chest pain on left side) and ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction) in a female patient of an unknown age 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 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), CHEST PAIN (Chest pain on left side), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction). At the time of the report, VACCINATION COMPLICATION (side effects after the second/ felt those were similar to the second shot reaction), NIGHT SWEATS (night sweating/We felt those were similar to the second shot reaction), ARTHRITIS (increase in feelings of arthritis in our arthritic areas/We felt those were similar to the second shot reaction), ARTHRALGIA (Joint pain/We felt those were similar to the second shot reaction), MYALGIA (aching everywhere/We felt those were similar to the second shot reaction), PYREXIA (Fever/We felt those were similar to the second shot reaction) and CHILLS (chills/We felt those were similar to the second shot reaction) outcome was unknown and CHEST PAIN (Chest pain on left side) had resolved. Not Provided          No concomitant products were reported.  Physician suggested couple of Advil should eliminate any pain.   This case was linked to MOD-2021-312693, MOD-2021-317608 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Less than 25 days since first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days since first shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 052E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PAROXETINE for an unknown indication.   On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days since first shot). On 12-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days since first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications includes blood pressure medicine. No treatment medications are provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Chills, Headache, Myalgia
Clinical narrative: Blood in the urine,urine looked like coffee; Body aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, BLOOD URINE PRESENT (Blood in the urine,urine looked like coffee), MYALGIA (Body aches), HEADACHE (Headache) and CHILLS (Chills) had not resolved.            No Concomitant Medication was provided. It was reported that lab results and blood results were all in order and the only thing out of the ordinary was the blood in the urine.    This case was linked to MOD-2021-317574 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick after vaccination.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after vaccination.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick after vaccination.). At the time of the report, ILLNESS (Sick after vaccination.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment, Nasopharyngitis, Somnolence
Clinical narrative: For 3 days, he didn't remember anything; He was cold; Next day after receiving 1st dose, he felt like zombie; The following day, he was sleeping almost all day/ He slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie), SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day), MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0030C21A) for COVID-19 vaccination.     Concomitant products included PREGABALIN (LYRICA), ROPINIROLE, GLIMEPIRIDE, PANTOPRAZOLE, ROSUVASTATIN, MAGNESIUM, NICOTINIC ACID (NIACIN) and AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for an unknown indication.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie) and SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day). On an unknown date, the patient experienced MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold). At the time of the report, FEELING ABNORMAL (Next day after receiving 1st dose, he felt like zombie), SOMNOLENCE (The following day, he was sleeping almost all day/ He slept all day), MEMORY IMPAIRMENT (For 3 days, he didn't remember anything) and NASOPHARYNGITIS (He was cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness on left arm below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on left arm below injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on left arm below injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness on left arm below injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included unspecified supplements.  After first dose, the patient had redness on left arm below injection site and than it disappeared.   This case was linked to MOD-2021-317610 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Denied) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided. Treatment information was not provided.  Company comment: This case concerns a  female patient with no relevant medical history reported, who experienced the expected event of Anaphylactic reaction after the first dose of mRNA-1273. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  female patient with no relevant medical history reported, who experienced the expected event of Anaphylactic reaction after the first dose of mRNA-1273. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Illness, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; strange illness; has never been this sick on her life; body pain/ body aches/really bad body pain/body pain that was severe; fever/ had a fever/fever of 102; chest pain; tachycardia/120's tachycardia; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHEA (runny nose), ILLNESS (strange illness), CHEST PAIN (chest pain), TACHYCARDIA (tachycardia/120's tachycardia) and ILLNESS (has never been this sick on her life) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049CZ1A and 011D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included FAMOTIDINE for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced CHEST PAIN (chest pain) and TACHYCARDIA (tachycardia/120's tachycardia). On an unknown date, the patient experienced RHINORRHEA (runny nose), ILLNESS (strange illness), ILLNESS (has never been this sick on her life), MYALGIA (body pain/ body aches/really bad body pain/body pain that was severe) and PYREXIA (fever/ had a fever/fever of 102). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) for Pain, at a dose of 15 mg and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 09-Sep-2021, CHEST PAIN (chest pain) and TACHYCARDIA (tachycardia/120's tachycardia) had resolved. At the time of the report, RHINORRHEA (runny nose), ILLNESS (strange illness), ILLNESS (has never been this sick on her life), MYALGIA (body pain/ body aches/really bad body pain/body pain that was severe) and PYREXIA (fever/ had a fever/fever of 102) outcome was unknown.            Diagnostic results: On 08 Sep2021-D dimer was slightly elevated (it was at 5 58).                            She went to the hospital, to the emergency department, she was all day there with tachycardia, fever of 102 and chest pain and body pain that was severe. she had a CAT scan for that. She was given IV fluids but nothing brought her heart rate down. She was discharged that nigh but was still with chest pain and 120's tachycardia, they just diagnosed that it was vaccine reaction symptoms   This case was linked to MOD-2021-286386 (Patient Link).   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: runny nose; strange illness; has never been this sick on her life; body pain/ body aches/really bad body pain/body pain that was severe; fever/ had a fever/fever of 102; chest pain; tachycardia/120's tachycardia; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHEA (runny nose), ILLNESS (strange illness), CHEST PAIN (chest pain), TACHYCARDIA (tachycardia/120's tachycardia) and ILLNESS (has never been this sick on her life) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049CZ1A and 011D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included FAMOTIDINE for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced CHEST PAIN (chest pain) and TACHYCARDIA (tachycardia/120's tachycardia). On an unknown date, the patient experienced RHINORRHEA (runny nose), ILLNESS (strange illness), ILLNESS (has never been this sick on her life), MYALGIA (body pain/ body aches/really bad body pain/body pain that was severe) and PYREXIA (fever/ had a fever/fever of 102). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) for Pain, at a dose of 15 mg and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 09-Sep-2021, CHEST PAIN (chest pain) and TACHYCARDIA (tachycardia/120's tachycardia) had resolved. At the time of the report, RHINORRHEA (runny nose), ILLNESS (strange illness), ILLNESS (has never been this sick on her life), MYALGIA (body pain/ body aches/really bad body pain/body pain that was severe) and PYREXIA (fever/ had a fever/fever of 102) outcome was unknown.            Diagnostic results: On 08 Sep2021-D dimer was slightly elevated (it was at 5 58).                            She went to the hospital, to the emergency department, she was all day there with tachycardia, fever of 102 and chest pain and body pain that was severe. she had a CAT scan for that. She was given IV fluids but nothing brought her heart rate down. She was discharged that nigh but was still with chest pain and 120's tachycardia, they just diagnosed that it was vaccine reaction symptoms   This case was linked to MOD-2021-286386 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Vaccination site movement impairment
Clinical narrative: Can't move her left arm; Extreme joint pain; Fatigue; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her left arm), ARTHRALGIA (Extreme joint pain), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy, Allergy (Sensitive on Ozone days), Allergy (Depakote) and Drug allergy (Augmentin). Concomitant products included LEVOTHYROXINE and PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Product used for unknown indication, ALPRAZOLAM, AMLODIPINE, OLMESARTAN, CLONIDINE, ESTRADIOL, PILOCARPINE NITRATE (PILOCARPINE EYE DROPS), ROSUVASTATIN, MONTELUKAST SODIUM (SINGULAIR), OXCARBAZEPINE (TRILEPTAL) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, SEROTONIN and ESZOPICLONE.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her left arm), ARTHRALGIA (Extreme joint pain), FATIGUE (Fatigue) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 26-Jul-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move her left arm), ARTHRALGIA (Extreme joint pain), FATIGUE (Fatigue) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included  Dymysta,, Ritlin and Zedia.   This case was linked to MOD-2021-045952 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen injection arm like the size of a golf ball; Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen injection arm like the size of a golf ball) and VACCINATION SITE PAIN (Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen injection arm like the size of a golf ball) and VACCINATION SITE PAIN (Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose). At the time of the report, VACCINATION SITE SWELLING (Swollen injection arm like the size of a golf ball) and VACCINATION SITE PAIN (Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose) outcome was unknown.            No concomitant medication was given by reporter. No treatment medication was given by reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Thirsty; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirsty) and PYREXIA (Fever) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced THIRST (Thirsty) and PYREXIA (Fever). At the time of the report, THIRST (Thirsty) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not reported. treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Vaccination site swelling
Clinical narrative: my eyes hurt like they are very dry yet they are not; arm  was swollen like baseball; had the chills for hours; head is throbbing; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (my eyes hurt like they are very dry yet they are not), VACCINATION SITE SWELLING (arm  was swollen like baseball), CHILLS (had the chills for hours) and HEADACHE (head is throbbing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EYE PAIN (my eyes hurt like they are very dry yet they are not), VACCINATION SITE SWELLING (arm  was swollen like baseball), CHILLS (had the chills for hours) and HEADACHE (head is throbbing). In September 2021, CHILLS (had the chills for hours) had resolved. At the time of the report, EYE PAIN (my eyes hurt like they are very dry yet they are not), VACCINATION SITE SWELLING (arm  was swollen like baseball) and HEADACHE (head is throbbing) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: terrible hives which started at the injection site and is now spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (terrible hives which started at the injection site and is now spreading) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (terrible hives which started at the injection site and is now spreading). At the time of the report, VACCINATION SITE URTICARIA (terrible hives which started at the injection site and is now spreading) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Skin discolouration, Vaccination complication
Clinical narrative: arm is so painful she cannot even sleep; arm from elbow to the top of the shoulder was black and blue; it travels from the upper arm to her neck; COVID arm; inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful), INSOMNIA (arm is so painful she cannot even sleep), SKIN DISCOLOURATION (arm from elbow to the top of the shoulder was black and blue), PAIN (it travels from the upper arm to her neck) and VACCINATION COMPLICATION (COVID arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 019B21A) for COVID-19 vaccination.     Concomitant products included MELOXICAM and Statin for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY (inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful). On an unknown date, the patient experienced INSOMNIA (arm is so painful she cannot even sleep), SKIN DISCOLOURATION (arm from elbow to the top of the shoulder was black and blue), PAIN (it travels from the upper arm to her neck) and VACCINATION COMPLICATION (COVID arm). At the time of the report, PAIN IN EXTREMITY (inside of her arm is in so much pain/Outside of the arm hurts/it's getting worse/stabbing pain in the top of her arm/if she sleeps on that side the pain is beyond/it's very painful), INSOMNIA (arm is so painful she cannot even sleep), PAIN (it travels from the upper arm to her neck) and VACCINATION COMPLICATION (COVID arm) had not resolved and SKIN DISCOLOURATION (arm from elbow to the top of the shoulder was black and blue) had resolved.            Patient took lot of vitamins no treatment medication was given
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: broke out with rash/rash all over back, neck, under his arm; sick with fever all weekend; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out with rash/rash all over back, neck, under his arm) and PYREXIA (sick with fever all weekend) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PYREXIA (sick with fever all weekend). On 12-Sep-2021, the patient experienced RASH (broke out with rash/rash all over back, neck, under his arm). At the time of the report, RASH (broke out with rash/rash all over back, neck, under his arm) and PYREXIA (sick with fever all weekend) outcome was unknown.            It was reported as Patient has no known allergies and has not taken any medications as treatment.  No Concomitant medications were reported. No Treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 4 Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 4 Moderna vaccines) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received 4 Moderna vaccines). At the time of the report, EXTRA DOSE ADMINISTERED (received 4 Moderna vaccines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided. The physician said that taking four vaccines would not hurt the patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.            No concomitant medications were reported. Patient utilized exercise and water to alleviate symptoms from first dose. Patient took second dose on 09-SEP-2021 in upper left arm (053E21A).   This case was linked to MOD-2021-317388 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip swelling for 3 days) in a 22-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 LIP SWELLING (lip swelling for 3 days). At the time of the report, LIP SWELLING (lip swelling for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Did not take any medication. No known allergies. Patient received the 1st dose of the Moderna vaccine last month. Then she had a swollen lip that lasted for 3 days.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up; cold (chills); The next day she got hot; she had all over muscle pain; her left arm down to her hand was numb; her left arm down to her hand was limp/she dropped things in her left hand a lot; tingling in her left arm when she got up; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (her left arm down to her hand was numb), MUSCULOSKELETAL STIFFNESS (her left arm down to her hand was limp/she dropped things in her left hand a lot), PARAESTHESIA (tingling in her left arm when she got up), NAUSEA (had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up) and CHILLS (cold (chills)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRON and BIOTIN for an unknown indication.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PARAESTHESIA (tingling in her left arm when she got up). On 21-Aug-2021, the patient experienced HYPOAESTHESIA (her left arm down to her hand was numb), MUSCULOSKELETAL STIFFNESS (her left arm down to her hand was limp/she dropped things in her left hand a lot) and MYALGIA (she had all over muscle pain). On 22-Aug-2021, the patient experienced CHILLS (cold (chills)) and PYREXIA (The next day she got hot). On 12-Sep-2021, the patient experienced NAUSEA (had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (her left arm down to her hand was numb), MUSCULOSKELETAL STIFFNESS (her left arm down to her hand was limp/she dropped things in her left hand a lot), PARAESTHESIA (tingling in her left arm when she got up), NAUSEA (had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up), CHILLS (cold (chills)), PYREXIA (The next day she got hot) and MYALGIA (she had all over muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up; cold (chills); The next day she got hot; she had all over muscle pain; her left arm down to her hand was numb; her left arm down to her hand was limp/she dropped things in her left hand a lot; tingling in her left arm when she got up; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (her left arm down to her hand was numb), MUSCULOSKELETAL STIFFNESS (her left arm down to her hand was limp/she dropped things in her left hand a lot), PARAESTHESIA (tingling in her left arm when she got up), NAUSEA (had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up) and CHILLS (cold (chills)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRON and BIOTIN for an unknown indication.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PARAESTHESIA (tingling in her left arm when she got up). On 21-Aug-2021, the patient experienced HYPOAESTHESIA (her left arm down to her hand was numb), MUSCULOSKELETAL STIFFNESS (her left arm down to her hand was limp/she dropped things in her left hand a lot) and MYALGIA (she had all over muscle pain). On 22-Aug-2021, the patient experienced CHILLS (cold (chills)) and PYREXIA (The next day she got hot). On 12-Sep-2021, the patient experienced NAUSEA (had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (her left arm down to her hand was numb), MUSCULOSKELETAL STIFFNESS (her left arm down to her hand was limp/she dropped things in her left hand a lot), PARAESTHESIA (tingling in her left arm when she got up), NAUSEA (had a lot of pain (cramping) with menstruation/pain (cramping) made her feel like she wanted to throw up), CHILLS (cold (chills)), PYREXIA (The next day she got hot) and MYALGIA (she had all over muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: 1st 2 doses: sick for 3 days; headache was tolerable; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (1st 2 doses: sick for 3 days) and HEADACHE (headache was tolerable) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction NOS (Allergic to almost everything (did not specify)). Concomitant products included RIVAROXABAN (XARELTO) and LEVOTHYROXINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ILLNESS (1st 2 doses: sick for 3 days) and HEADACHE (headache was tolerable). In January 2021, ILLNESS (1st 2 doses: sick for 3 days) had resolved. At the time of the report, HEADACHE (headache was tolerable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient concomitant medication include Supplements and Cholesterol medication. No treatment information provided for dose 1.   This case was linked to MOD-2021-317412 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: I don't have any energy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I don't have any energy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced ASTHENIA (I don't have any energy). At the time of the report, ASTHENIA (I don't have any energy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: sick for 1 week also; 3rd dose: worst headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 1 week also) and HEADACHE (3rd dose: worst headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, RIVAROXABAN (XARELTO) for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 1 week also) and HEADACHE (3rd dose: worst headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick for 1 week also) outcome was unknown and HEADACHE (3rd dose: worst headache) had not resolved.            This case was linked to MOD-2021-317581, MOD-2021-317412 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Productive cough
Clinical narrative: My throat's sore; Mucousy; If I'm getting sick I don't need to go get the shot; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (My throat's sore), PRODUCTIVE COUGH (Mucousy) and ILLNESS (If I'm getting sick I don't need to go get the shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (My throat's sore), PRODUCTIVE COUGH (Mucousy) and ILLNESS (If I'm getting sick I don't need to go get the shot). At the time of the report, OROPHARYNGEAL PAIN (My throat's sore), PRODUCTIVE COUGH (Mucousy) and ILLNESS (If I'm getting sick I don't need to go get the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant informations were reported. No treatment informations were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Fatigue, Myalgia
Clinical narrative: stomach cramping; bouts of diarrhea; lower back pain; achiness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (bouts of diarrhea), BACK PAIN (lower back pain), MYALGIA (achiness) and FATIGUE (tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (bouts of diarrhea), BACK PAIN (lower back pain), MYALGIA (achiness) and FATIGUE (tiredness). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), DIARRHOEA (bouts of diarrhea), BACK PAIN (lower back pain), MYALGIA (achiness) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported. treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Chills, Myalgia, Night sweats
Clinical narrative: increase in feelings of arthritis in our arthritic areas; night sweating; aching everywhere; Joint pain; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (increase in feelings of arthritis in our arthritic areas), NIGHT SWEATS (night sweating), MYALGIA (aching everywhere), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age 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 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (increase in feelings of arthritis in our arthritic areas), NIGHT SWEATS (night sweating), MYALGIA (aching everywhere), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (chills). At the time of the report, ARTHRITIS (increase in feelings of arthritis in our arthritic areas), NIGHT SWEATS (night sweating), MYALGIA (aching everywhere), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-317606, MOD-2021-312693, MOD-2021-316965.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: increase in feelings of arthritis in our arthritic areas; night sweating; aching everywhere; Joint pain; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (increase in feelings of arthritis in our arthritic areas), NIGHT SWEATS (night sweating), MYALGIA (aching everywhere), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age 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 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (increase in feelings of arthritis in our arthritic areas), NIGHT SWEATS (night sweating), MYALGIA (aching everywhere), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (chills). At the time of the report, ARTHRITIS (increase in feelings of arthritis in our arthritic areas), NIGHT SWEATS (night sweating), MYALGIA (aching everywhere), ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-317606, MOD-2021-312693, MOD-2021-316965.