chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: heat at the injection site; swelling at the injection site; tenderness at the injection site, it went away little by little but it was very tender the first week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PAIN (tenderness at the injection site, it went away little by little but it was very tender the first week) and VACCINATION SITE SWELLING (swelling at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site, it went away little by little but it was very tender the first week). On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 07-Feb-2021, VACCINATION SITE PAIN (tenderness at the injection site, it went away little by little but it was very tender the first week) had resolved. At the time of the report, VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.; Area of the injection hurt; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Area of the injection hurt) and VACCINATION SITE RASH (Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M28A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Area of the injection hurt). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.). At the time of the report, VACCINATION SITE PAIN (Area of the injection hurt) and VACCINATION SITE RASH (Rash around the injection site measuring about 3.5 x 5 cm, irregularly shaped.) 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 relevant concomitant medications were reported. No treatment information was reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 01-Jan-2021 and the estimated date of delivery was 10-Oct-2021. On 16-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 16-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pregnancy test: positive (Positive) Positive. On 24-Feb-2021, Ultrasound foetal: normal (normal) normal.     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 was provided by the reporter. No Treatment medications was provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Mass, Pollakiuria
Clinical narrative: urinating more frequently; lump under her chin on the left side/ lump has grown in size over the last hour; dizzy; her heart seems to be beating faster than normal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HEART RATE INCREASED (her heart seems to be beating faster than normal), MASS (lump under her chin on the left side/ lump has grown in size over the last hour) and POLLAKIURIA (urinating more frequently) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (dizzy) and HEART RATE INCREASED (her heart seems to be beating faster than normal). On 10-Feb-2021, the patient experienced MASS (lump under her chin on the left side/ lump has grown in size over the last hour). On an unknown date, the patient experienced POLLAKIURIA (urinating more frequently). At the time of the report, DIZZINESS (dizzy), HEART RATE INCREASED (her heart seems to be beating faster than normal), MASS (lump under her chin on the left side/ lump has grown in size over the last hour) and POLLAKIURIA (urinating more frequently) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No specific follow-up information recorded. On 24-Jun-2021:Significant follow up; Patient reported that AE's not resolved
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on his right arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PAIN IN EXTREMITY (soreness on his right arm). At the time of the report, PAIN IN EXTREMITY (soreness on his right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      No treatment information was provided. No relevant concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch; Injection site swelling; Injection site tenderness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site tenderness) and VACCINATION SITE ERYTHEMA (Injection site redness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site tenderness) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE WARMTH (Hot to touch), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE PAIN (Injection site tenderness) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment information were reported.   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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pain, Pyrexia
Clinical narrative: body ache; headache; slit temperature 99.9F,fever; arm and shoulder are very sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body ache), PYREXIA (slit temperature 99.9F,fever) and ARTHRALGIA (arm and shoulder are very sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache), PAIN (body ache), PYREXIA (slit temperature 99.9F,fever) and ARTHRALGIA (arm and shoulder are very sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) had resolved and PAIN (body ache), PYREXIA (slit temperature 99.9F,fever) and ARTHRALGIA (arm and shoulder are very sore) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 99.9 f (High) 99.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported are blood pressure medication and allergies medication
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: some symptoms I have and I'm having; A spontaneous report was received from a consumer, concerning herself a female patient of unknown age, who had to receive her first dose on (9-02-2021) Moderna's COVID-19 vaccine would like to some information regarding vaccine  The patient's medical history was not provided, concomitant medication was not provided by reporter.  On unknow date patient had to received their first dose of two planned doses of mRNA-1273 (lot number not provided) via unknown route for COVID-19 infection prophylaxis but she had some previous medical history so she want to take advice from safety regarding vaccine   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was not resolved at the time of this report
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: Eye itch; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Eye itch) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced EYE PRURITUS (Eye itch). At the time of the report, EYE PRURITUS (Eye itch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: experiencing most of the general side effects; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events most of the general side effects/adverse drug reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unavailable) (unknown route) for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) most of the general side effects.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), most of the general side effects was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Diarrhoea, Nasal congestion, Pyrexia
Clinical narrative: Redness in vaccination area; Blotching in vaccination area/noticed rash on arm, right around vaccination site; Runny nose; Chest tightness; Coughing/persistent cough; Congestion; Diarrhea; Sinus headache/persistent sinus headache; SLIGHT FEVER; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough), NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (ROSUSTATIN), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), SINUS HEADACHE (Sinus headache/persistent sinus headache) and PYREXIA (SLIGHT FEVER). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in vaccination area) and VACCINATION SITE RASH (Blotching in vaccination area/noticed rash on arm, right around vaccination site). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), PYREXIA (SLIGHT FEVER), VACCINATION SITE ERYTHEMA (Redness in vaccination area) and VACCINATION SITE RASH (Blotching in vaccination area/noticed rash on arm, right around vaccination site) outcome was unknown and CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough) and SINUS HEADACHE (Sinus headache/persistent sinus headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086580 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Concomitant medication list was updated, event verbatim added, event outcomes updated. On 27-May-2021: Non-Significant follow up appended to MOD-2021-027155; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086580:Case for dose 2
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus headache, Vaccination site erythema, Vaccination site rash
Clinical narrative: Redness in vaccination area; Blotching in vaccination area/noticed rash on arm, right around vaccination site; Runny nose; Chest tightness; Coughing/persistent cough; Congestion; Diarrhea; Sinus headache/persistent sinus headache; SLIGHT FEVER; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough), NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (ROSUSTATIN), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced RHINORRHOEA (Runny nose), CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), SINUS HEADACHE (Sinus headache/persistent sinus headache) and PYREXIA (SLIGHT FEVER). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in vaccination area) and VACCINATION SITE RASH (Blotching in vaccination area/noticed rash on arm, right around vaccination site). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), PYREXIA (SLIGHT FEVER), VACCINATION SITE ERYTHEMA (Redness in vaccination area) and VACCINATION SITE RASH (Blotching in vaccination area/noticed rash on arm, right around vaccination site) outcome was unknown and CHEST DISCOMFORT (Chest tightness), COUGH (Coughing/persistent cough) and SINUS HEADACHE (Sinus headache/persistent sinus headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086580 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Concomitant medication list was updated, event verbatim added, event outcomes updated. On 27-May-2021: Non-Significant follow up appended to MOD-2021-027155; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086580:Case for dose 2
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: severe adverse reactions; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (severe adverse reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe adverse reactions). At the time of the report, VACCINATION COMPLICATION (severe adverse reactions) 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 medications or treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Hot flush
Clinical narrative: dry coughing; hot to cold flashes; joint pain; fatigued and tiredness; Headaches; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hot to cold flashes, dry coughing, fatigued, joint pain, tiredness and headaches.  The patient's medical history was not provided. Concomitant medications reported were Wellurine -  an anti depressant for drug use for unknown indication.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 8 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced Arthralgia (joint pain), Cough, Fatigue, Headache and Hot flush (hot and cold flash)  Treatment details included nothing.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site lymphadenopathy
Clinical narrative: lymph nodes in her armpit were enlarged, in the same side of the injection; Lymph node pain; lymph nodes in the neck were swollen, in the same side of the injection.; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph nodes in her armpit were enlarged, in the same side of the injection), LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (lymph nodes in the neck were swollen, in the same side of the injection.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph nodes in her armpit were enlarged, in the same side of the injection), LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (lymph nodes in the neck were swollen, in the same side of the injection.). On 22-Jan-2021, VACCINATION SITE LYMPHADENOPATHY (lymph nodes in her armpit were enlarged, in the same side of the injection), LYMPH NODE PAIN (Lymph node pain) and LYMPHADENOPATHY (lymph nodes in the neck were swollen, in the same side of the injection.) 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 concomitants were reported. No treatment was reported.; 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
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 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Nov-2020 and the estimated date of delivery was 07-Sep-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: positive (Positive) Positive.     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.   Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Symptoms of COVID-19 disease; Pain in Injection Site; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Symptoms of COVID-19 disease) and VACCINATION SITE PAIN (Pain in Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in Injection Site). On 30-Jan-2021, the patient experienced COVID-19 (Symptoms of COVID-19 disease). On 08-Jan-2021, VACCINATION SITE PAIN (Pain in Injection Site) had resolved. At the time of the report, COVID-19 (Symptoms of COVID-19 disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid with symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid with symptoms) 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. In February 2021, the patient experienced COVID-19 (Covid with symptoms). At the time of the report, COVID-19 (Covid with symptoms) 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 linked to MOD-2021-027169 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: nausea; Body ache; high fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PAIN (Body ache) and PYREXIA (high fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 06-Feb-2021, the patient experienced NAUSEA (nausea), PAIN (Body ache) and PYREXIA (high fever). At the time of the report, NAUSEA (nausea), PAIN (Body ache) and PYREXIA (high fever) outcome was unknown. Not Provided
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Felt very sleepy; felt very tired; Sore arm; Very low energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Very low energy), SOMNOLENCE (Felt very sleepy) and FATIGUE (felt very tired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), ASTHENIA (Very low energy) and FATIGUE (felt very tired). On an unknown date, the patient experienced SOMNOLENCE (Felt very sleepy). At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Very low energy), SOMNOLENCE (Felt very sleepy) and FATIGUE (felt very tired) outcome was unknown. Not Provided          It was reported that the patient might be taking diabetes medication (unspecified).  No information regarding treatment was provided. This case is for caller's son's dad and is crosslinked with MOD21-020942 and MOD21-020907.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21-MAY-2021 updated contact information, professional physical mail.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Body Aches; Could hardly get up; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body Aches) and FATIGUE (Could hardly get up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body Aches) and FATIGUE (Could hardly get up). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body Aches) and FATIGUE (Could hardly get up) outcome was unknown. Not Provided
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Rash, Rash papular, Urticaria
Clinical narrative: Small rash on legs and ankles; Hives; Raised red rash on leg, arm and waist; Fatigue; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), URTICARIA (Hives), RASH PAPULAR (Raised red rash on leg, arm and waist), RASH (Small rash on legs and ankles) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (Soreness) and FATIGUE (Fatigue). On 23-Jan-2021, the patient experienced URTICARIA (Hives) and RASH PAPULAR (Raised red rash on leg, arm and waist). On 05-Feb-2021, the patient experienced RASH (Small rash on legs and ankles). On 22-Jan-2021, PAIN (Soreness) and FATIGUE (Fatigue) had resolved. On 26-Jan-2021, URTICARIA (Hives) had resolved, RASH PAPULAR (Raised red rash on leg, arm and waist) outcome was unknown. At the time of the report, RASH (Small rash on legs and ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Claritin. No relevant concomitant medications reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red spot where he received the injection; mild soreness; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE ERYTHEMA (Red spot where he received the injection) and INJECTION SITE PAIN (mild soreness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red spot where he received the injection) and INJECTION SITE PAIN (mild soreness). At the time of the report, INJECTION SITE ERYTHEMA (Red spot where he received the injection) and INJECTION SITE PAIN (mild soreness) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: big red patch on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red patch on her left arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced ERYTHEMA (big red patch on her left arm). At the time of the report, ERYTHEMA (big red patch on her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Headache, Nausea, Vaccination site pain
Clinical narrative: a lot after she received the vaccine; Slight headache; pain in the injection site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS ( a lot after she received the vaccine), HEADACHE (Slight headache), VACCINATION SITE PAIN (pain in the injection site) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Inflammatory bowel disease (with constipation).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (a lot after she received the vaccine), HEADACHE (Slight headache), VACCINATION SITE PAIN (pain in the injection site) and NAUSEA (Nausea). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) on 08-Feb-2021 for Vaccination site pain, at an unspecified dose and frequency. On 09-Feb-2021, HEADACHE (Slight headache) had resolved. At the time of the report, FREQUENT BOWEL MOVEMENTS ( a lot after she received the vaccine) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE PAIN (pain in the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for nausea included ginger ale and coffee.  Concomitant medication was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Rash macular, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Numbness in my face and lips, predominantly on my right side but a little bit on my left side; Numbness in my lips, predominantly on my right side but a little bit on my left side; Red blotch at the injection site and 5days later turned into a bull's eye; Large welt immediately after the shot, at the injection site / Red blotch at the injection site; Red blotch at the injection site and 5days later turned into a bull's eye; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in my face and lips, predominantly on my right side but a little bit on my left side), HYPOAESTHESIA ORAL (Numbness in my lips, predominantly on my right side but a little bit on my left side), RASH MACULAR (Red blotch at the injection site and 5days later turned into a bull's eye), VACCINATION SITE URTICARIA (Large welt immediately after the shot, at the injection site / Red blotch at the injection site) and VACCINATION SITE ERYTHEMA (Red blotch at the injection site and 5days later turned into a bull's eye) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL 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 13-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in my face and lips, predominantly on my right side but a little bit on my left side), HYPOAESTHESIA ORAL (Numbness in my lips, predominantly on my right side but a little bit on my left side), RASH MACULAR (Red blotch at the injection site and 5days later turned into a bull's eye), VACCINATION SITE URTICARIA (Large welt immediately after the shot, at the injection site / Red blotch at the injection site) and VACCINATION SITE ERYTHEMA (Red blotch at the injection site and 5days later turned into a bull's eye). In January 2021, HYPOAESTHESIA (Numbness in my face and lips, predominantly on my right side but a little bit on my left side), HYPOAESTHESIA ORAL (Numbness in my lips, predominantly on my right side but a little bit on my left side) and VACCINATION SITE URTICARIA (Large welt immediately after the shot, at the injection site / Red blotch at the injection site) had resolved. At the time of the report, RASH MACULAR (Red blotch at the injection site and 5days later turned into a bull's eye) outcome was unknown and VACCINATION SITE ERYTHEMA (Red blotch at the injection site and 5days later turned into a bull's eye) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided for the events.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: COVID arm; It's kind of bump, red, and itches; Rash that developed a week later at the injection site; It's kind of bump, red, and itches; It's kind of bump, red, and itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (It's kind of bump, red, and itches), VACCINATION SITE RASH (Rash that developed a week later at the injection site), VACCINATION SITE SWELLING (It's kind of bump, red, and itches) and VACCINATION SITE ERYTHEMA (It's kind of bump, red, and itches) 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 VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (It's kind of bump, red, and itches), VACCINATION SITE RASH (Rash that developed a week later at the injection site), VACCINATION SITE SWELLING (It's kind of bump, red, and itches) and VACCINATION SITE ERYTHEMA (It's kind of bump, red, and itches). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (It's kind of bump, red, and itches), VACCINATION SITE RASH (Rash that developed a week later at the injection site), VACCINATION SITE SWELLING (It's kind of bump, red, and itches) and VACCINATION SITE ERYTHEMA (It's kind of bump, red, and itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Vaccination site pruritus
Clinical narrative: a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes; a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PRURITUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) and VACCINATION SITE PRURITUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes). On 30-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) was resolving and VACCINATION SITE PRURITUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked to MOD-2021-028823 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Product administered at inappropriate site
Clinical narrative: it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4"; got the injection on her left arm, but she thinks it's a little too high; sore and hard to sleep on it; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (sore and hard to sleep on it), ERYTHEMA (it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4") and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the injection on her left arm, but she thinks it's a little too high) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A or 042L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (to antibiotics).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (sore and hard to sleep on it) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the injection on her left arm, but she thinks it's a little too high). On an unknown date, the patient experienced ERYTHEMA (it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4"). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 28-Jan-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the injection on her left arm, but she thinks it's a little too high) had resolved. At the time of the report, LIMB DISCOMFORT (sore and hard to sleep on it) outcome was unknown and ERYTHEMA (it started to get red again. It's a circle and got bigger and bigger; still pink, and it's 3" x 4") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pallor, Presyncope
Clinical narrative: Feels like he was about to pass out; White as ghost; Body ache; Fever; chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feels like he was about to pass out), PALLOR (White as ghost), PAIN (Body ache), PYREXIA (Fever) and CHILLS (chills) in a 71-year-old male 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRESYNCOPE (Feels like he was about to pass out), PALLOR (White as ghost), PAIN (Body ache), PYREXIA (Fever), CHILLS (chills) and ARTHRALGIA (Joint pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Adverse event, at a dose of 2 UNK. At the time of the report, PRESYNCOPE (Feels like he was about to pass out), PALLOR (White as ghost), PAIN (Body ache), PYREXIA (Fever), CHILLS (chills) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feels like he was about to pass out; White as ghost; Body ache; Fever; chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feels like he was about to pass out), PALLOR (White as ghost), PAIN (Body ache), PYREXIA (Fever) and CHILLS (chills) in a 71-year-old male 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRESYNCOPE (Feels like he was about to pass out), PALLOR (White as ghost), PAIN (Body ache), PYREXIA (Fever), CHILLS (chills) and ARTHRALGIA (Joint pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Adverse event, at a dose of 2 UNK. At the time of the report, PRESYNCOPE (Feels like he was about to pass out), PALLOR (White as ghost), PAIN (Body ache), PYREXIA (Fever), CHILLS (chills) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.   Reporter did not allow further contact