chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Maternal exposure during pregnancy
Clinical narrative: was pregnant and received the vaccine; she is not feeling so strong; Not feeling well; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine), ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-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 an unknown date and the estimated date of delivery was unspecified date. On 13-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine), ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well). The cesarean delivery occurred on unspecified date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (was pregnant and received the vaccine) had resolved and ASTHENIA (she is not feeling so strong) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment history was not reported .; Sender's Comments: This is a case of maternal exposure during pregnancy (vaccine exposure during pregnancy) for this 45-year-old female. The female underwent cesarean section and delivered a live baby10 days after the first dose of mRNA-1273. The patient also reports asthenia and malaise. Based on the available information, the events are confounded by preceding cesarean delivery. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Malaise, Nasal congestion, Pain in extremity
Clinical narrative: congestion; legs were very painful; some fever; got infected with covid-19/ breakthrough case; a little bit of malaise; slight fatigue/ extreme fatigue/ they were very tired; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RABEPRAZOLE SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL ALLERGY 24HR), MAGNESIUM, AZELASTINE, COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (a little bit of malaise) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired). In August 2021, the patient experienced DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case). On an unknown date, the patient experienced NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and PYREXIA (some fever). At the time of the report, DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful), FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) and PYREXIA (some fever) 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.   Patient treatment included Over-the-counter stuff.  Patient said that she is in her 70s.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: congestion; legs were very painful; some fever; got infected with covid-19/ breakthrough case; a little bit of malaise; slight fatigue/ extreme fatigue/ they were very tired; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RABEPRAZOLE SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL ALLERGY 24HR), MAGNESIUM, AZELASTINE, COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (a little bit of malaise) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired). In August 2021, the patient experienced DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case). On an unknown date, the patient experienced NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and PYREXIA (some fever). At the time of the report, DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful), FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) and PYREXIA (some fever) 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.   Patient treatment included Over-the-counter stuff.  Patient said that she is in her 70s.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm for couple of days) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm for couple of days). At the time of the report, MYALGIA (Sore arm for couple of days) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Her arm hurt a little bit; fever; nausea appeared again; Diarrhea appeared again/diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt a little bit), DIARRHOEA (Diarrhea appeared again/diarrhea), NAUSEA (Nausea), PYREXIA (fever) and NAUSEA (nausea appeared again) 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 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced DIARRHOEA (Diarrhea appeared again/diarrhea) and NAUSEA (Nausea). On 31-Aug-2021, the patient experienced PYREXIA (fever) and NAUSEA (nausea appeared again). On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm hurt a little bit). On 30-Aug-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Her arm hurt a little bit), DIARRHOEA (Diarrhea appeared again/diarrhea), PYREXIA (fever) and NAUSEA (nausea appeared again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot to the touch; itching; very painful; big, red rash around injection site; big, red rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful), VACCINATION SITE ERYTHEMA (big, red rash around injection site) and VACCINATION SITE RASH (big, red rash around injection site) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), CETIRIZINE for Allergy, LEVOTHYROXINE, METFORMIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 27-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced VACCINATION SITE RASH (big, red rash around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful) and VACCINATION SITE ERYTHEMA (big, red rash around injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency; IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), PRURITUS (itching), PAIN (very painful), VACCINATION SITE ERYTHEMA (big, red rash around injection site) and VACCINATION SITE RASH (big, red rash around injection site) outcome was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Vertigo
Clinical narrative: Vertigo; Loosing balance but has not fallen, feels like the room is tilting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and BALANCE DISORDER (Loosing balance but has not fallen, feels like the room is tilting) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included FOLIC ACID, METOPROLOL, FUROSEMIDE, AMLODIPINE, OLMESARTAN MEDOXOMIL and ALLOPURINOL (ALOPURINOL) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-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 VERTIGO (Vertigo) and BALANCE DISORDER (Loosing balance but has not fallen, feels like the room is tilting). At the time of the report, VERTIGO (Vertigo) and BALANCE DISORDER (Loosing balance but has not fallen, feels like the room is tilting) outcome was unknown.      Concomitant medication also include Tantoprazole.  About two weeks after receiving second dose of the vaccine came down with vertigo occurring all throughout the day. Patient stated that he can function but he just can't climb up on a chair or ladder.  No treatment information were provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: The usual sore arm; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (The usual sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (The usual sore arm). On 30-Jan-2021, MYALGIA (The usual sore arm) 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 medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-303204, MOD-2021-303300 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Paraesthesia
Clinical narrative: Tingling sensation on both sides of his body; Sweated at night; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night). On 25-Aug-2021, PARAESTHESIA (Tingling sensation on both sides of his body) and NIGHT SWEATS (Sweated at night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product includes High Blood Pressure medication. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: pain in his left hip radiating down the leg; The pain started on Sunday and got worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse) 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 ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse). At the time of the report, ARTHRALGIA (pain in his left hip radiating down the leg) and CONDITION AGGRAVATED (The pain started on Sunday and got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown.            No concomitant product information were provided by the reporter. Patient went into the need for surgery on the pleura 2 months ago. No treatment information was provided by the reporter.  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.; 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: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: What happens if the second dose is applied for more than a month; 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 UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month). At the time of the report, UNEVALUABLE EVENT (What happens if the second dose is applied for more than a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in December 2020 and the estimated date of delivery was 15-Nov-2021. On 31-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 31-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported Treatment medication were not reported Patient was 29 weeks pregnant. Patient got injection to the shoulder; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (hasn't had a second dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced  product dose omission issue (hasn't had a second dose). At the time of the report,  product dose omission issue (hasn't had a second dose) resolved. No concomitant medications or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: >35 days since first dose,  My first dose was March 18. How long can I go between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (>35 days since first dose,  My first dose was March 18. How long can I go between doses) 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.    On 18-Mar-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 (>35 days since first dose,  My first dose was March 18. How long can I go between doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (>35 days since first dose,  My first dose was March 18. How long can I go between doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He was tested positive for COVID-19 /He had mild symptoms; Lack of drug effect; He had mild chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He was tested positive for COVID-19 /He had mild symptoms), DRUG INEFFECTIVE (Lack of drug effect) and CHILLS (He had mild chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CHILLS (He had mild chills). On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (He was tested positive for COVID-19 /He had mild symptoms) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (He was tested positive for COVID-19 /He had mild symptoms) and CHILLS (He had mild chills) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.; Sender's Comments: This is a case of Drug ineffective with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Constipation, Flatulence, Paraesthesia, Pyrexia
Clinical narrative: tingling in his left leg; constipated/been using the bathroom like a rabbit; really bad gas/nothing is coming out just horrible smell; Pain at site; felt like he had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-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 PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever). At the time of the report, PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal.     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.    Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received with no new information.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tingling in his left leg; constipated/been using the bathroom like a rabbit; really bad gas/nothing is coming out just horrible smell; Pain at site; felt like he had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-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 PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever). At the time of the report, PARAESTHESIA (tingling in his left leg), CONSTIPATION (constipated/been using the bathroom like a rabbit), FLATULENCE (really bad gas/nothing is coming out just horrible smell), VACCINATION SITE PAIN (Pain at site) and PYREXIA (felt like he had a fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal.     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.    Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received with no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; did not get 2th dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and PRODUCT DOSE OMISSION ISSUE (did not get 2th dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 Positive) in October 2020, Stomach upset, Nausea and Plasma transfusion (Donated COVID plasma). Concurrent medical conditions included Drug allergy (Allergy to eye contact solution) and Allergic reaction to analgesics (Allergy to Naproxen).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TINNITUS (Tinnitus) and PRODUCT DOSE OMISSION ISSUE (did not get 2th dose). In 2021, PRODUCT DOSE OMISSION ISSUE (did not get 2th dose) had resolved. At the time of the report, TINNITUS (Tinnitus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. patient stated because of this side effect she is afraid of getting second dose of Moderna covid-19 vaccine. patient reports she has no comorbidities and is overall healthy No Treatment medications were reported.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine; Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021.     This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine) and WRONG PRODUCT ADMINISTERED (Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine) and WRONG PRODUCT ADMINISTERED (Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine). On 31-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Mistakenly vaccinated a  15 year old male patient for his first dose with Moderna Covid-19 Vaccine) and WRONG PRODUCT ADMINISTERED (Mistakenly vaccinated  Moderna Covid-19 Vaccine instead of Pfizer Covid-19 Vaccine) 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 medications were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Intentional product use issue
Clinical narrative: agitated; She didn't get the 2nd dose a month later because the family was concerned about her reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of AGITATION (agitated) and INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose a month later because the family was concerned about her reaction) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had covid in December 2020) in December 2020 and Encephalitis in December 2020.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 AGITATION (agitated) and INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose a month later because the family was concerned about her reaction). At the time of the report, AGITATION (agitated) and INTENTIONAL PRODUCT USE ISSUE (She didn't get the 2nd dose a month later because the family was concerned about her reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter. Starting the day after the first dose, she was agitated. It lasted less than a week and she was acting like a typical elderly patient with a UTI, which she did not have.   This case was linked to MOD-2021-303462 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use). On 04-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (enlarged lymph nodes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph nodes). At the time of the report, LYMPHADENOPATHY (enlarged lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter No treatment Drug was reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Fatigue
Clinical narrative: tired/fatigued; chronic dry eyes have gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/fatigued) and DRY EYE (chronic dry eyes have gotten worse) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-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 FATIGUE (tired/fatigued) and DRY EYE (chronic dry eyes have gotten worse). At the time of the report, FATIGUE (tired/fatigued) outcome was unknown and DRY EYE (chronic dry eyes have gotten worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She has chronic dry eyes and they seem to have gotten worse after the vaccine.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash where shot was given,rash is bigger than a 50 cent piece; started itching, so patient scratched it; rash where shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rash where shot was given,rash is bigger than a 50 cent piece), VACCINATION SITE PRURITUS (started itching, so patient scratched it) and VACCINATION SITE RASH (rash where shot was given) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE RASH (rash where shot was given). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (rash where shot was given,rash is bigger than a 50 cent piece) and VACCINATION SITE PRURITUS (started itching, so patient scratched it). At the time of the report, VACCINATION SITE ERYTHEMA (rash where shot was given,rash is bigger than a 50 cent piece), VACCINATION SITE PRURITUS (started itching, so patient scratched it) and VACCINATION SITE RASH (rash where shot was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Hallucination, Inappropriate schedule of product administration, Lethargy
Clinical narrative: hallucinating thinking that people are in the next room; agitated; she is lethargic; 1st dose in February of 2021 & 2nd dose on 23Aug2021; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (hallucinating thinking that people are in the next room) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Encephalitis in December 2020.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HALLUCINATION (hallucinating thinking that people are in the next room) (seriousness criterion medically significant), AGITATION (agitated), LETHARGY (she is lethargic) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in February of 2021 & 2nd dose on 23Aug2021). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in February of 2021 & 2nd dose on 23Aug2021) had resolved. At the time of the report, HALLUCINATION (hallucinating thinking that people are in the next room), AGITATION (agitated) and LETHARGY (she is lethargic) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided She doesn't have dementia.  Company comment- Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-303411 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dyspnoea exertional, Nausea, Nervousness
Clinical narrative: Shaky; Nauseous; Shortness of breath after going up staircase; Felt weak; Cancer drug causes loss of balance; The patient was ready to die, the pain was incredible; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Cancer drug causes loss of balance), PAIN (The patient was ready to die, the pain was incredible), DYSPNOEA EXERTIONAL (Shortness of breath after going up staircase), ASTHENIA (Felt weak) and NERVOUSNESS (Shaky) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058Z21A, 013A21A and 012M2BA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer and Migraine. Concomitant products included AMITRIPTYLINE, DIAZEPAM, FLURAZEPAM and PERPHENAZINE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced BALANCE DISORDER (Cancer drug causes loss of balance) and PAIN (The patient was ready to die, the pain was incredible). On 28-Aug-2021, the patient experienced ASTHENIA (Felt weak). On 29-Aug-2021, the patient experienced DYSPNOEA EXERTIONAL (Shortness of breath after going up staircase). On an unknown date, the patient experienced NERVOUSNESS (Shaky) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Pain, at a dose of 400 mg every six hours. At the time of the report, BALANCE DISORDER (Cancer drug causes loss of balance), PAIN (The patient was ready to die, the pain was incredible), DYSPNOEA EXERTIONAL (Shortness of breath after going up staircase), ASTHENIA (Felt weak), NERVOUSNESS (Shaky) and NAUSEA (Nauseous) outcome was unknown.            Concomitant product included breast cancer pill. Patient planned to see cardiologist for echocardiogram and blood test.  The patient has been tapering the doses of breast cancer pill and reported that 2 days ago, the patient tapered one of them and asked whether this was the cause of symptoms. The patient did not have a history of myocarditis/pericarditis and COVID-19 infection.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded. Causality is confounded by the patient's history of breast cancer.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Shaky; Nauseous; Shortness of breath after going up staircase; Felt weak; Cancer drug causes loss of balance; The patient was ready to die, the pain was incredible; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Cancer drug causes loss of balance), PAIN (The patient was ready to die, the pain was incredible), DYSPNOEA EXERTIONAL (Shortness of breath after going up staircase), ASTHENIA (Felt weak) and NERVOUSNESS (Shaky) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058Z21A, 013A21A and 012M2BA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer and Migraine. Concomitant products included AMITRIPTYLINE, DIAZEPAM, FLURAZEPAM and PERPHENAZINE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced BALANCE DISORDER (Cancer drug causes loss of balance) and PAIN (The patient was ready to die, the pain was incredible). On 28-Aug-2021, the patient experienced ASTHENIA (Felt weak). On 29-Aug-2021, the patient experienced DYSPNOEA EXERTIONAL (Shortness of breath after going up staircase). On an unknown date, the patient experienced NERVOUSNESS (Shaky) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN for Pain, at a dose of 400 mg every six hours. At the time of the report, BALANCE DISORDER (Cancer drug causes loss of balance), PAIN (The patient was ready to die, the pain was incredible), DYSPNOEA EXERTIONAL (Shortness of breath after going up staircase), ASTHENIA (Felt weak), NERVOUSNESS (Shaky) and NAUSEA (Nauseous) outcome was unknown.            Concomitant product included breast cancer pill. Patient planned to see cardiologist for echocardiogram and blood test.  The patient has been tapering the doses of breast cancer pill and reported that 2 days ago, the patient tapered one of them and asked whether this was the cause of symptoms. The patient did not have a history of myocarditis/pericarditis and COVID-19 infection.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded. Causality is confounded by the patient's history of breast cancer.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Achiness; Headache; Feeling Tired; Misunderstood the return time frame; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Achiness), HEADACHE (Headache), FATIGUE (Feeling Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Misunderstood the return time frame) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021 at 4:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021 at 4:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Misunderstood the return time frame). On an unknown date, the patient experienced PAIN (Achiness), HEADACHE (Headache) and FATIGUE (Feeling Tired). At the time of the report, PAIN (Achiness), HEADACHE (Headache) and FATIGUE (Feeling Tired) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Misunderstood the return time frame) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.   This case was linked to MOD-2021-255385 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.