chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort, Chills, Feeling abnormal, Head discomfort
Clinical narrative: sore arm; she felt really bad; could barely move her right arm; flu-like symptoms; numbness in her arms, feet, & legs on both sides of her body but more so on the right side; pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side; weird sensations & pressure in her chest; weird sensations & pressure in her head; a sharp radiating sensation near her right collar bone; had a low grade fever; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms) and HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-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 IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side), PARAESTHESIA (pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side), CHEST DISCOMFORT (weird sensations & pressure in her chest), HEAD DISCOMFORT (weird sensations & pressure in her head), BONE PAIN (a sharp radiating sensation near her right collar bone), PYREXIA (had a low grade fever) and CHILLS (bad chills). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side), PARAESTHESIA (pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side), CHEST DISCOMFORT (weird sensations & pressure in her chest), HEAD DISCOMFORT (weird sensations & pressure in her head), BONE PAIN (a sharp radiating sensation near her right collar bone), PYREXIA (had a low grade fever) and CHILLS (bad chills) 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: sore arm; she felt really bad; could barely move her right arm; flu-like symptoms; numbness in her arms, feet, & legs on both sides of her body but more so on the right side; pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side; weird sensations & pressure in her chest; weird sensations & pressure in her head; a sharp radiating sensation near her right collar bone; had a low grade fever; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms) and HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-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 IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side), PARAESTHESIA (pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side), CHEST DISCOMFORT (weird sensations & pressure in her chest), HEAD DISCOMFORT (weird sensations & pressure in her head), BONE PAIN (a sharp radiating sensation near her right collar bone), PYREXIA (had a low grade fever) and CHILLS (bad chills). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side), PARAESTHESIA (pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side), CHEST DISCOMFORT (weird sensations & pressure in her chest), HEAD DISCOMFORT (weird sensations & pressure in her head), BONE PAIN (a sharp radiating sensation near her right collar bone), PYREXIA (had a low grade fever) and CHILLS (bad chills) 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm; she felt really bad; could barely move her right arm; flu-like symptoms; numbness in her arms, feet, & legs on both sides of her body but more so on the right side; pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side; weird sensations & pressure in her chest; weird sensations & pressure in her head; a sharp radiating sensation near her right collar bone; had a low grade fever; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms) and HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-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 IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side), PARAESTHESIA (pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side), CHEST DISCOMFORT (weird sensations & pressure in her chest), HEAD DISCOMFORT (weird sensations & pressure in her head), BONE PAIN (a sharp radiating sensation near her right collar bone), PYREXIA (had a low grade fever) and CHILLS (bad chills). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (she felt really bad), MOBILITY DECREASED (could barely move her right arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPOAESTHESIA (numbness in her arms, feet, & legs on both sides of her body but more so on the right side), PARAESTHESIA (pins & needles in her arms, feet, & legs on both sides of her body but more so on the right side), CHEST DISCOMFORT (weird sensations & pressure in her chest), HEAD DISCOMFORT (weird sensations & pressure in her head), BONE PAIN (a sharp radiating sensation near her right collar bone), PYREXIA (had a low grade fever) and CHILLS (bad chills) 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was diagnosed with COVID-19 after having had two doses of the Moderna vaccine; lack of efficacy; . This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was diagnosed with COVID-19 after having had two doses of the Moderna vaccine) and DRUG INEFFECTIVE (lack of efficacy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 225421A and 010M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ZOLPIDEM, SIMVASTATIN and OCRELIZUMAB (OCREVUS) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 COVID-19 (I was diagnosed with COVID-19 after having had two doses of the Moderna vaccine) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (I was diagnosed with COVID-19 after having had two doses of the Moderna vaccine) had resolved and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.            No treatment medication were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: full on vertigo, I had it for two days to a week.; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (full on vertigo, I had it for two days to a week.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0032B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (full on vertigo, I had it for two days to a week.). At the time of the report, VERTIGO (full on vertigo, I had it for two days to a week.) had resolved.            No concomitant medications were reported.   The patient came down with full on vertigo, had never experienced it before. She had it for two days to a week. Took that long to get equilibrium  back.  No treatment information was provided.   This case was linked to MOD-2021-283110 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site pain, Vaccination site swelling
Clinical narrative: No fever but feels hot; Pain at the injection site; Swelling at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING HOT (No fever but feels hot), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Autoimmune disorder (About a week or two ago, she was diagnosed with 2 different autoimmune deficiency.) since July 2021, Drug allergy (Cilins), Allergic reaction to analgesics (Morphine) and Allergic reaction to antibiotics (Vancomycin).    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced FEELING HOT (No fever but feels hot), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, FEELING HOT (No fever but feels hot), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient said that the pain she had was not interfering with her activities but it was quite painful. She also drew a circle on the swelling to check if it was getting larger. No treatment information was provided.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with Covid-19, not severe; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid-19, not severe) in a 7-decade-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosed with Covid-19, not severe). At the time of the report, COVID-19 (diagnosed with Covid-19, not severe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient was in their late 60s. The patient got covid-19, but not as severe. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (swollen lymph nodes) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (swollen lymph nodes). At the time of the report, lymphadenopathy (swollen lymph nodes) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. Patient reported at follow-up, the EKG value: sinus brady not so great. Most recent follow-up information incorporated: On Aug 11, 2021: Follow-up received. In follow-up EKG, chest X-ray and mammogram done.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash erythematous
Clinical narrative: It looks like allergies reactions.; I'm having all kind of breakouts rash since then/These is going on, I have a huge rash in my feet; I got a red rash that went away two days after. I'm having all kind of breakouts rash since then. It looks like allergies reactions. These is going on, I have a huge rash in my feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (I got a red rash that went away two days after. I'm having all kind of breakouts rash since then. It looks like allergies reactions. These is going on, I have a huge rash in my feet), HYPERSENSITIVITY (It looks like allergies reactions.) and RASH (I'm having all kind of breakouts rash since then/These is going on, I have a huge rash in my feet) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Ankle operation (Ankle transplant).   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (I got a red rash that went away two days after. I'm having all kind of breakouts rash since then. It looks like allergies reactions. These is going on, I have a huge rash in my feet), HYPERSENSITIVITY (It looks like allergies reactions.) and RASH (I'm having all kind of breakouts rash since then/These is going on, I have a huge rash in my feet). At the time of the report, RASH ERYTHEMATOUS (I got a red rash that went away two days after. I'm having all kind of breakouts rash since then. It looks like allergies reactions. These is going on, I have a huge rash in my feet) had resolved and HYPERSENSITIVITY (It looks like allergies reactions.) and RASH (I'm having all kind of breakouts rash since then/These is going on, I have a huge rash in my feet) outcome was unknown.            Patient current medical history include Blood pressure. Concomitant medications include Blood pressure pills. Treatment medications include antibiotics for Rash.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got the first dose on 15May2021 and have not received the second one yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first dose on 15May2021 and have not received the second one yet) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first dose on 15May2021 and have not received the second one yet). On 15-May-2021, PRODUCT DOSE OMISSION ISSUE (Got the first dose on 15May2021 and have not received the second one yet) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: Experirnced side effects; A lymphatic response; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Aug-2021 and was forwarded to Moderna on 10-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experirnced side effects) and LYMPHADENOPATHY (A lymphatic response) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004021A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-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 COMPLICATION (Experirnced side effects) and LYMPHADENOPATHY (A lymphatic response). At the time of the report, VACCINATION COMPLICATION (Experirnced side effects) and LYMPHADENOPATHY (A lymphatic response) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-283397 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 42 days for administration of second dose/ patient has not gotten second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 42 days for administration of second dose/ patient has not gotten second dose yet) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 42 days for administration of second dose/ patient has not gotten second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 42 days for administration of second dose/ patient has not gotten second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No Treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Face oedema
Clinical narrative: Severe facial edema; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (Severe facial edema) 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 provided.     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 FACE OEDEMA (Severe facial edema) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Face edema, at an unspecified dose and frequency. At the time of the report, FACE OEDEMA (Severe facial edema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported . The patient reported that he was treated at an urgent care facility with epinephrine and wanted to confirm if this was a delayed reaction to the vaccine or not.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: nausea/ nausea is killing me; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever). At the time of the report, NAUSEA (nausea/ nausea is killing me) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Younger women who had their cycles all messed up since they have the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Younger women who had their cycles all messed up since they have the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Younger women who had their cycles all messed up since they have the vaccine). At the time of the report, MENSTRUATION IRREGULAR (Younger women who had their cycles all messed up since they have the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Vaccination site erythema, Vaccination site rash
Clinical narrative: feeling tired; red rash around injection site; red rash around injection site; pain under armpit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rash around injection site), AXILLARY PAIN (pain under armpit), FATIGUE (feeling tired) and VACCINATION SITE RASH (red rash around injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Ibuprofen) and Bee sting hypersensitivity. Concomitant products included PROBIOTICS NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash around injection site), AXILLARY PAIN (pain under armpit) and VACCINATION SITE RASH (red rash around injection site). On 11-Aug-2021, the patient experienced FATIGUE (feeling tired). At the time of the report, VACCINATION SITE ERYTHEMA (red rash around injection site), AXILLARY PAIN (pain under armpit), FATIGUE (feeling tired) and VACCINATION SITE RASH (red rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information does not provided by the reporter.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back) and PAIN IN EXTREMITY (Sore arm) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LURASIDONE HYDROCHLORIDE (LATUDA), ATOMOXETINE HYDROCHLORIDE (STRATTERA), GUANFACINE HYDROCHLORIDE (TENEX), MOMETASONE FUROATE (ASMANEX) and DUPILUMAB (DUPIXENT) for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced HYPOAESTHESIA (Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HYPOAESTHESIA (Numbness, originally, started below  his elbow and upper arm, and now it has affected his shoulder, neck and around his shoulder blade on his back/cannot feel his upper lower back) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was  provided.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Menstrual Cramping after vaccination; Excessive Bleeding after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSMENORRHOEA (Menstrual Cramping after vaccination) and HEAVY MENSTRUAL BLEEDING (Excessive Bleeding after vaccination) 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 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSMENORRHOEA (Menstrual Cramping after vaccination) and HEAVY MENSTRUAL BLEEDING (Excessive Bleeding after vaccination). At the time of the report, DYSMENORRHOEA (Menstrual Cramping after vaccination) and HEAVY MENSTRUAL BLEEDING (Excessive Bleeding after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and C39C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy. Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.   Treatment information was not provided.   This case was linked to MOD-2021-283366 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Loss of control of legs, Pain in extremity, Pyrexia
Clinical narrative: Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky; Whole body was shaking; Arm hurting really bad; Headache; Fever; he was laying on his stomach; No control of his legs and his arms; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky) and LOSS OF CONTROL OF LEGS (No control of his legs and his arms) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C39C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergic reaction to analgesics. Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced LOSS OF CONTROL OF LEGS (No control of his legs and his arms) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (he was laying on his stomach). On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky) (seriousness criterion medically significant), TREMOR (Whole body was shaking), PAIN IN EXTREMITY (Arm hurting really bad), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SEIZURE (Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky), LOSS OF CONTROL OF LEGS (No control of his legs and his arms), TREMOR (Whole body was shaking), ABDOMINAL DISCOMFORT (he was laying on his stomach), PAIN IN EXTREMITY (Arm hurting really bad), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            On 09Aug2021, patient experienced headaches and fever. At night, he was laying on his stomach, and his arm was hurting really bad. He was bouncing off the bed and had convulsions at around midnight. His whole body was shaking. There were no control of his legs and his arms and states it was spooky.   No relevant treatment medication information provided.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-283365 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Tremor
Clinical narrative: Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky; Whole body was shaking; Arm hurting really bad; Headache; Fever; he was laying on his stomach; No control of his legs and his arms; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky) and LOSS OF CONTROL OF LEGS (No control of his legs and his arms) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C39C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergic reaction to analgesics. Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced LOSS OF CONTROL OF LEGS (No control of his legs and his arms) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (he was laying on his stomach). On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky) (seriousness criterion medically significant), TREMOR (Whole body was shaking), PAIN IN EXTREMITY (Arm hurting really bad), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, SEIZURE (Had convulsions at around midnight/was bouncing off the bed/no control of his legs and his arms/ states that it was spooky), LOSS OF CONTROL OF LEGS (No control of his legs and his arms), TREMOR (Whole body was shaking), ABDOMINAL DISCOMFORT (he was laying on his stomach), PAIN IN EXTREMITY (Arm hurting really bad), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            On 09Aug2021, patient experienced headaches and fever. At night, he was laying on his stomach, and his arm was hurting really bad. He was bouncing off the bed and had convulsions at around midnight. His whole body was shaking. There were no control of his legs and his arms and states it was spooky.   No relevant treatment medication information provided.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-283365 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) 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 July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-May-2021 and the estimated date of delivery was 19-Feb-2022. In July 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        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 was not provided.  No treatment medications was not provided. The second dose of vaccine was scheduled on 10-Aug-2021.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receives a vaccine one day after it's expired; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receives a vaccine one day after it's expired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EXPIRED PRODUCT ADMINISTERED (receives a vaccine one day after it's expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receives a vaccine one day after it's expired) had resolved.        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 information is provided bythe reporter No treatment information provided.   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphorrhoea, Suspected COVID-19
Clinical narrative: COVID  like symptoms; swollen lymph nodes; oozing lymph nodes; This spontaneous case was reported by a non-health professional and describes the occurrence of SUSPECTED COVID-19 (COVID  like symptoms), LYMPHADENOPATHY (swollen lymph nodes) and LYMPHORRHOEA (oozing lymph nodes   ) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21a and 004021a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-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 SUSPECTED COVID-19 (COVID  like symptoms), LYMPHADENOPATHY (swollen lymph nodes) and LYMPHORRHOEA (oozing lymph nodes   ). At the time of the report, SUSPECTED COVID-19 (COVID  like symptoms), LYMPHADENOPATHY (swollen lymph nodes) and LYMPHORRHOEA (oozing lymph nodes   ) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2021-283253 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Rosacea
Clinical narrative: Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine; Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ROSACEA (Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine) and INTENTIONAL PRODUCT USE ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LISINOPRIL, ATORVASTATIN, TRAZODONE and HYDROXYZINE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ROSACEA (Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine) and INTENTIONAL PRODUCT USE ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, ROSACEA (Patient developed rosacea after receiving the first dose of the Moderna COVID-19 vaccine) and INTENTIONAL PRODUCT USE ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) 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 treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: in fact am in Day 12 of having covid.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (in fact am in Day 12 of having covid.) 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (in fact am in Day 12 of having covid.). At the time of the report, COVID-19 (in fact am in Day 12 of having covid.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Lymphadenopathy, Myalgia
Clinical narrative: Covid arm with swelling; Redness; Arm felt hot; Rash; Swollen lymph node under arm; Achy all last week; Tired all last week; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash), LYMPHADENOPATHY (Swollen lymph node under arm), MYALGIA (Achy all last week) and FATIGUE (Tired all last week). At the time of the report, SWELLING (Covid arm with swelling) and ERYTHEMA (Redness) had not resolved, FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) outcome was unknown and MYALGIA (Achy all last week) and FATIGUE (Tired all last week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and medical history were not provided by the reporter. Treatment medicine were not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Covid arm with swelling; Redness; Arm felt hot; Rash; Swollen lymph node under arm; Achy all last week; Tired all last week; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash), LYMPHADENOPATHY (Swollen lymph node under arm), MYALGIA (Achy all last week) and FATIGUE (Tired all last week). At the time of the report, SWELLING (Covid arm with swelling) and ERYTHEMA (Redness) had not resolved, FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) outcome was unknown and MYALGIA (Achy all last week) and FATIGUE (Tired all last week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and medical history were not provided by the reporter. Treatment medicine were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 PRODUCT DOSE OMISSION ISSUE (got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got their 1 st dose of the Moderna COVID-19 Vaccine on January2021.,wants get their second dose of Moderna Covid-19 Vaccine, today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact