chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: Slight cough; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion). At the time of the report, COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion). At the time of the report, COUGH (Slight cough) and NASAL CONGESTION (Nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction). At the time of the report, ADVERSE REACTION (Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction). At the time of the report, ADVERSE REACTION (Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Retching, Tremor
Clinical narrative: muscle aches; Violent shaking all over; dry heaves; extreme chills; vomiting; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 6:00 PM, the patient experienced TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she called 911 when events happened, but she did not go to the hospital.   Concomitant medications were not provided.  Treatment information was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 6:00 PM, the patient experienced TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she called 911 when events happened, but she did not go to the hospital.   Concomitant medications were not provided.  Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: muscle aches; Violent shaking all over; dry heaves; extreme chills; vomiting; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 6:00 PM, the patient experienced TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she called 911 when events happened, but she did not go to the hospital.   Concomitant medications were not provided.  Treatment information was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 6:00 PM, the patient experienced TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting) and HEADACHE (headache). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, TREMOR (Violent shaking all over), RETCHING (dry heaves), CHILLS (extreme chills), VOMITING (vomiting), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she called 911 when events happened, but she did not go to the hospital.   Concomitant medications were not provided.  Treatment information was not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Got vaccine while Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 14-Jan-2021 and the estimated date of delivery was 22-Oct-2021. On 05-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, at an unspecified dose and frequency. On 05-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include allergies medication and rescue inhaler.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 40-year-old female. The patient's estimated due date is on 23 Mar 2021. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; A spontaneous report was received via voicemail from a daughter, concerning her father, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, the reporter stated her father experienced severe pain. She mentioned her father was at the doctor. No treatment information was provided.   The outcome for the event, severe pain, was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced a nonserious unexpected event of severe pain. Event details were not provided.  The event occurred with unknown latency after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested. Based on 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever 101.9 F; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.9 F), HEADACHE (headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Fever 101.9 F), HEADACHE (headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 101.9 F), HEADACHE (headache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient take Tylenol one yesterday and one today morning; 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. Further information has been requested
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Right arm warm to touch; Hardness on arm where vaccinated; Right arm swelled; Right arm skin turned pink; Itching on arm where vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE INDURATION (Hardness on arm where vaccinated), VACCINATION SITE PRURITUS (Itching on arm where vaccinated), VACCINATION SITE SWELLING (Right arm swelled) and VACCINATION SITE ERYTHEMA (Right arm skin turned pink) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included NADOLOL, LOSARTAN and AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE INDURATION (Hardness on arm where vaccinated), VACCINATION SITE SWELLING (Right arm swelled) and VACCINATION SITE ERYTHEMA (Right arm skin turned pink). In January 2021, the patient experienced VACCINATION SITE PRURITUS (Itching on arm where vaccinated). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Right arm warm to touch), VACCINATION SITE INDURATION (Hardness on arm where vaccinated), VACCINATION SITE PRURITUS (Itching on arm where vaccinated), VACCINATION SITE SWELLING (Right arm swelled) and VACCINATION SITE ERYTHEMA (Right arm skin turned pink) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included application of warm washcloth.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021 included new information: Adverse event outcomes recovered.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at injection site; Itching at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site).   The patient was treated with ALCOHOL for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PRURITUS (Itching at injection site) and INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Pyrexia, Sluggishness
Clinical narrative: a temperature of 102.7F; Not eating; sluggish; A spontaneous report was received from a consumer concerning an 81-year- old, female patient who experienced a temperature of 102.7F and sluggishness.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.       On 21JAN2021, approximately 21hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:032L20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient's daughter stated that her mother received the first dose of the Moderna mRNA-1273 vaccine on 21Jan2021 around 4PM at the Health clinic. On 22JAN2021 Friday around 1PM patient's temperature rose to 102.7F and patient was not eating. Daughter was able to get patient's fever down by administering 1000mg of Tylenol. On the following morning, patient became sluggish and fever returned to 101.8F at 4PM. Patient's physician recommended the patient take 1G of Tylenol Q8H as needed. Patient received second dose of Tylenol on 23JAN2021.    Action taken with mRNA-1273 in response to the events was unknown.  The events, a temperature of 102.7F and sluggishness were considered recovering/resolving.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Jul-2020 and the estimated date of delivery was 19-Apr-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at first and second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. she delivered baby and baby is 2 months. On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient was pregnant at first and second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Genetic testing was abnormal before vaccination, however, at the time of report it was normal. The number of fetuses was reported as 1 and had established prenatal care. There was no complications and acute illness during this pregnancy to date. The patient gave full-term  live birth to baby on 09-Mar-2021 (at 39 weeks and 7 days). There was no maternal history of subfertility.  It was reported that mother and baby were doing good and had no adverse events.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Birth type and narrative was updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Pain in extremity, Pruritus, Rash papular
Clinical narrative: Area raised and swollen; Itching; Lump; Area raised and swollen; small red area by injection; some soreness in the arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (small red area by injection), PAIN IN EXTREMITY (some soreness in the arm), PRURITUS (Itching), INJECTION SITE NODULE (Lump) and RASH PAPULAR (Area raised and swollen) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (small red area by injection) and PAIN IN EXTREMITY (some soreness in the arm). On 24-Jan-2021, the patient experienced PRURITUS (Itching), INJECTION SITE NODULE (Lump) and RASH PAPULAR (Area raised and swollen). On 25-Jan-2021, the patient experienced SWELLING (Area raised and swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (small red area by injection), PAIN IN EXTREMITY (some soreness in the arm), PRURITUS (Itching), INJECTION SITE NODULE (Lump), RASH PAPULAR (Area raised and swollen) and SWELLING (Area raised and swollen) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Area raised and swollen; Itching; Lump; Area raised and swollen; small red area by injection; some soreness in the arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (small red area by injection), PAIN IN EXTREMITY (some soreness in the arm), PRURITUS (Itching), INJECTION SITE NODULE (Lump) and RASH PAPULAR (Area raised and swollen) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (small red area by injection) and PAIN IN EXTREMITY (some soreness in the arm). On 24-Jan-2021, the patient experienced PRURITUS (Itching), INJECTION SITE NODULE (Lump) and RASH PAPULAR (Area raised and swollen). On 25-Jan-2021, the patient experienced SWELLING (Area raised and swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE ERYTHEMA (small red area by injection), PAIN IN EXTREMITY (some soreness in the arm), PRURITUS (Itching), INJECTION SITE NODULE (Lump), RASH PAPULAR (Area raised and swollen) and SWELLING (Area raised and swollen) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling hot
Clinical narrative: body feels warm; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (body feels warm) and COUGH (Dry cough) 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 05-Apr-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 FEELING HOT (body feels warm) and COUGH (Dry cough). At the time of the report, FEELING HOT (body feels warm) outcome was unknown and COUGH (Dry cough) had resolved.            Concomitant product use was not provided. No treatment was reported.   This case was linked to MOD-2021-164589 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR document was attached. Event was recovered.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: couple of adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ADVERSE EVENT (couple of adverse events) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (couple of adverse events). At the time of the report, ADVERSE EVENT (couple of adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received on 6-JULY-2021 and does not contain any new information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot, red and itchy at injection site; Large hard lump at injection site; Hot, red and itchy at injection site; Swelling at injection site; Hot, red and itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot, red and itchy at injection site), VACCINATION SITE INDURATION (Large hard lump at injection site), VACCINATION SITE PRURITUS (Hot, red and itchy at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Hot, red and itchy at injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot, red and itchy at injection site), VACCINATION SITE INDURATION (Large hard lump at injection site), VACCINATION SITE PRURITUS (Hot, red and itchy at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Hot, red and itchy at injection site). At the time of the report, VACCINATION SITE WARMTH (Hot, red and itchy at injection site), VACCINATION SITE INDURATION (Large hard lump at injection site), VACCINATION SITE PRURITUS (Hot, red and itchy at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Hot, red and itchy at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment which included Ice and warm water.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: The Follow up case was received on 14-APR-2021. Event out come updated. On 09-Jun-2021: Follow up received on 09-jun-2021 contains no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: My back aches; Very sore arm; My injection site arm aches and is sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My back aches), PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE PAIN (My injection site arm aches and is sore) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin allergy). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MONTELUKAST SODIUM (SINGULAIR), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for Allergy, VITAMINS NOS (MULTIPLE VITAMIN) and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced BACK PAIN (My back aches), PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE PAIN (My injection site arm aches and is sore) and FATIGUE (tired). On 24-Jan-2021, BACK PAIN (My back aches), PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE PAIN (My injection site arm aches and is sore) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up information included, reporter details, patient demographic details, medical history, concomitant medication, event start date and stop date.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: feeling really bad; cough; allergy symptoms; fever; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4 f (High) She had  fever that shot up to 100.4 F and after about 20 minutes it went up to 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: feeling really bad; cough; allergy symptoms; fever; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4 f (High) She had  fever that shot up to 100.4 F and after about 20 minutes it went up to 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at the injection site; A spontaneous report was received from an other health professional concerning patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and experienced a rash at the injection site.  The patient's medical history and concomitant medication were not reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, after administration of vaccine, some of the patients had a rash at the injection site. Treatment information was not reported.  Action taken with the mRNA-1273 in response to the event was unknown.   The outcome of event rash at the injection site was unknown at the time of this report.; Reporter'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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site pain
Clinical narrative: Shingles/ Rash in the back of neck/ it hurts on touch; pain from where he got shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles/ Rash in the back of neck/ it hurts on touch) and VACCINATION SITE PAIN (pain from where he got shot) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Shingles.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain from where he got shot). On 16-Jan-2021, the patient experienced HERPES ZOSTER (Shingles/ Rash in the back of neck/ it hurts on touch). At the time of the report, HERPES ZOSTER (Shingles/ Rash in the back of neck/ it hurts on touch) and VACCINATION SITE PAIN (pain from where he got shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 events, a causal relationship cannot be excluded. Although, based also on the known available information and mechanism of action for the Moderna vaccine, the event of PT herpes zoster is unlikely related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warm; Red (Erythema-like); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Red (Erythema-like)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Red (Erythema-like)). At the time of the report, VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Red (Erythema-like)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site bruising, Vaccination site erythema, Vaccination site paraesthesia
Clinical narrative: bruising in the area of injection of vaccine; tingling in the area of injection of the vaccine; discomfort; ncreasing markings where the injection took place over 3 square inches in area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruising in the area of injection of vaccine), VACCINATION SITE PARAESTHESIA (tingling in the area of injection of the vaccine), DISCOMFORT (discomfort) and VACCINATION SITE ERYTHEMA (ncreasing markings where the injection took place over 3 square inches in area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE BRUISING (bruising in the area of injection of vaccine), VACCINATION SITE PARAESTHESIA (tingling in the area of injection of the vaccine), DISCOMFORT (discomfort) and VACCINATION SITE ERYTHEMA (ncreasing markings where the injection took place over 3 square inches in area). At the time of the report, VACCINATION SITE BRUISING (bruising in the area of injection of vaccine), VACCINATION SITE PARAESTHESIA (tingling in the area of injection of the vaccine), DISCOMFORT (discomfort) and VACCINATION SITE ERYTHEMA (ncreasing markings where the injection took place over 3 square inches in area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID and they were all asymptomatic). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID and they were all asymptomatic) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, corona test: positive (Positive) Asymptomatic. On 15-Jan-2021, pcr test: positive (Positive) Asymptomatic. On 15-Jan-2021, rapid test: positive (Positive) Asymptomatic.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of COVID-19 positive test in a patient who received mRNA-1273. Causality is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Rash on other arm; The injection site increasingly swelling up; The injection site was red; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced rash on other arm, the injection site increasingly swelling up and the injection site was red.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.   On an unknown date, a few days ago, after the vaccine administration, the patient experienced rash on her other arm and additionally her injection site had increasingly swelling up and was red.  Action taken with mRNA-1273 in response to the events were unknown.   The outcome of the events rash on other arm, the injection site increasingly swelling up and the injection site was red were considered unknown at the time of this report.; Reporter'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: COVID-19, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fatigued; possible fever: 99.9 highest temp; Covid 19 virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid 19 virus), HEADACHE (Headache), FATIGUE (Fatigued) and PYREXIA (possible fever: 99.9 highest temp) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2020, the patient experienced COVID-19 (Covid 19 virus). On 25-Jan-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigued) and PYREXIA (possible fever: 99.9 highest temp). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid 19 virus), HEADACHE (Headache), FATIGUE (Fatigued) and PYREXIA (possible fever: 99.9 highest temp) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Round red rash at the injection site; Round red rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Round red rash at the injection site) and VACCINATION SITE ERYTHEMA (Round red rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Round red rash at the injection site) and VACCINATION SITE ERYTHEMA (Round red rash at the injection site). At the time of the report, VACCINATION SITE RASH (Round red rash at the injection site) and VACCINATION SITE ERYTHEMA (Round red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: TCR received- Email id received On 18-Jun-2021: TCR received- Follow up denied
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (arm is swelling). At the time of the report, VACCINATION SITE WARMTH (arm is hot), VACCINATION SITE PRURITUS (arm is itchy), VACCINATION SITE ERYTHEMA (arm is red) and VACCINATION SITE SWELLING (arm is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dry mouth, Dysphonia, Pyrexia
Clinical narrative: Dry mouth; Raspy Throat; Cough; Fever of 99; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Raspy Throat) and COUGH (Cough) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) 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) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPHONIA (Raspy Throat) and COUGH (Cough). At the time of the report, DYSPHONIA (Raspy Throat) and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: arm was sore; body ache; Headache; Exhausted; The spontaneous report from was received from a consumer concerning a 75 years old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced arm  sore, exhausted had a major fatigue, headache and body ache.   The patient's medical history was not provided.  The concomitant medication included: Vitamin D3, Vitamin C, Probiotic and Aspirin with Crestor.  On 22 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot no. 032L20H) of COVID-19 infection.  On 23 Jan 2021, the patient experienced the events arm was sore, was exhausted had a major fatigue, headache and body ache.  Laboratory details are not provided.  The treatment medication included Ibuprofen  The outcomes of all the events was unknown.; Sender's Comments: Based on 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.