chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lips that last 3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (swollen lips that last 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips that last 3 days). At the time of the report, LIP SWELLING (swollen lips that last 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Patient due for their second injection tomorrow.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea
Clinical narrative: Everyone thinks he's being crazy and he feels terrible; headache constantly; feels nausea everyday; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Everyone thinks he's being crazy and he feels terrible), HEADACHE (headache constantly) and NAUSEA (feels nausea everyday) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Everyone thinks he's being crazy and he feels terrible), HEADACHE (headache constantly) and NAUSEA (feels nausea everyday). At the time of the report, FEELING ABNORMAL (Everyone thinks he's being crazy and he feels terrible), HEADACHE (headache constantly) and NAUSEA (feels nausea everyday) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Everyone thinks it must be from something else but patient feels confident its from vaccine. Patient states that no one is helping him.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Tiredness; Nausea; Low grade fever; Pain at the site of the injection (upper left body); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Tiredness), NAUSEA (Nausea), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left body)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced CHILLS (Chills), FATIGUE (Tiredness), NAUSEA (Nausea), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left body)). At the time of the report, CHILLS (Chills), FATIGUE (Tiredness), NAUSEA (Nausea), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Pain at the site of the injection (upper left body)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Insomnia; Sore throat; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and INSOMNIA (Insomnia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). On an unknown date, the patient experienced INSOMNIA (Insomnia). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and INSOMNIA (Insomnia) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness, Lethargy, Malaise, Nausea
Clinical narrative: flu-like symptoms; general malaise; lethargy; severe diarrhea; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (general malaise), LETHARGY (lethargy), DIARRHOEA (severe diarrhea) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 12M20A and 062E21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (general malaise), LETHARGY (lethargy), DIARRHOEA (severe diarrhea) and NAUSEA (nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), MALAISE (general malaise), LETHARGY (lethargy), DIARRHOEA (severe diarrhea) and NAUSEA (nausea) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Severe side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe side effects). At the time of the report, VACCINATION COMPLICATION (Severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Illness, Oral mucosal blistering, Oral pain
Clinical narrative: mouth hurts; sores in her mouth/ mouth sores; mouth blisters started to appear; teeth felt sore; got sick; very weak; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), ASTHENIA (very weak), TOOTHACHE (teeth felt sore), ORAL MUCOSAL BLISTERING (mouth blisters started to appear) and ORAL PAIN (mouth hurts) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (got sick), ASTHENIA (very weak), VOMITING (vomiting) and CHILLS (chills). On 12-Sep-2021, the patient experienced TOOTHACHE (teeth felt sore). On 13-Sep-2021, the patient experienced ORAL MUCOSAL BLISTERING (mouth blisters started to appear). On 14-Sep-2021, the patient experienced ORAL PAIN (mouth hurts) and STOMATITIS (sores in her mouth/ mouth sores). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Sore mouth, at a dose of 1 dosage form. At the time of the report, ILLNESS (got sick), ASTHENIA (very weak), TOOTHACHE (teeth felt sore), ORAL MUCOSAL BLISTERING (mouth blisters started to appear), ORAL PAIN (mouth hurts), STOMATITIS (sores in her mouth/ mouth sores), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.            No concomitant medications was provided by the reporter.  Patient stated she has never had mouth blisters like this in the past.  She stated that she doesn't take any medications daily.  She reported that she was not pregnant.     Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non significant follow up On 14-Sep-2021: Follow up information added patient identities, vaccine information, Events and treatment drug were updated.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Toothache, Vomiting
Clinical narrative: mouth hurts; sores in her mouth/ mouth sores; mouth blisters started to appear; teeth felt sore; got sick; very weak; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), ASTHENIA (very weak), TOOTHACHE (teeth felt sore), ORAL MUCOSAL BLISTERING (mouth blisters started to appear) and ORAL PAIN (mouth hurts) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (got sick), ASTHENIA (very weak), VOMITING (vomiting) and CHILLS (chills). On 12-Sep-2021, the patient experienced TOOTHACHE (teeth felt sore). On 13-Sep-2021, the patient experienced ORAL MUCOSAL BLISTERING (mouth blisters started to appear). On 14-Sep-2021, the patient experienced ORAL PAIN (mouth hurts) and STOMATITIS (sores in her mouth/ mouth sores). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Sore mouth, at a dose of 1 dosage form. At the time of the report, ILLNESS (got sick), ASTHENIA (very weak), TOOTHACHE (teeth felt sore), ORAL MUCOSAL BLISTERING (mouth blisters started to appear), ORAL PAIN (mouth hurts), STOMATITIS (sores in her mouth/ mouth sores), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.            No concomitant medications was provided by the reporter.  Patient stated she has never had mouth blisters like this in the past.  She stated that she doesn't take any medications daily.  She reported that she was not pregnant.     Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Non significant follow up On 14-Sep-2021: Follow up information added patient identities, vaccine information, Events and treatment drug were updated.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever/100.1/99.6; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever/100.1/99.6) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/100.1/99.6). At the time of the report, PYREXIA (fever/100.1/99.6) had not resolved.    Caller reports they received the second dose of Moderna around 11:00am on 13Sept2021 done in the left arm. Caller reports first dose was done in left arm as well.  Caller experiencing  fever and just wanted to know if it's safe to take Tylenol or Advil.  Concomitant medications was not reported.  Treatment medications was not reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: following the vaccination I had approximately a 1 hour drive home.  I arrived home around 1230pm and proceeded to complete some chores around the house.  my wife and I had plans for the evening so I began getting ready for that around 2pm.  it was at that time that I noticed the ringing in my ears (tinnitus).  I was inclined to believe that it was related to some mild nasal congestion from spring allergies.  It was persistent, non stop, for the next 2 days at which time I had an appointment with my PCP for a pre-surgical clearance.  I mentioned the tinnitus to him at that time and he believed it to be related to allergies and sinus congestion as well.  To this date the tinnitus is unresolved and has been present non stop.  I have not sought other treatment or follow up medical advice.  I have done my best to cope and live with the tinnitus, however I do feel as if it is beginning to affect my hearing as I find myself asking people to repeat them selves when they speak to me.  If I am not fully focused on someone speaking to me and looking in their direction I feel that I am not hearing them well just one ear,
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under armpit
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Mobility decreased, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Pain, swelling, and tenderness at vaccination site starting approx. 4 days after vaccination. Pain, weakness, and lack of mobility in left shoulder (front) and upper left arm (front) starting approx. 4 days after vaccination.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain, swelling, and tenderness at vaccination site starting approx. 4 days after vaccination. Pain, weakness, and lack of mobility in left shoulder (front) and upper left arm (front) starting approx. 4 days after vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Vaginal haemorrhage
Clinical narrative: Severe pain at injection site from day 1. Day 2, I experienced vaginal bleeding, very light.  Day 3, pain in armpit below injection site and swelling.  (FYI: after 1st dose, menstrual cycle was abnormal)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure during pregnancy, Fatigue, Headache, Malaise
Clinical narrative: 21 weeks pregnant, estimated date of delivery: 01/29/2022 The day after the shot: sore arm, headache, fatigue, general unwell feeling, nausea 3rd day after the shot: diarrhoea, nausea
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: 21 weeks pregnant, estimated date of delivery: 01/29/2022 The day after the shot: sore arm, headache, fatigue, general unwell feeling, nausea 3rd day after the shot: diarrhoea, nausea
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dyspnoea, Enlarged uvula, Erythema
Clinical narrative: Tongue, uvula, and felt like throat swelled within the first 15 minutes but not to a point that I couldn't breath. Tongue, uvula, and felt like throat have stayed inflamed. Within the next 18 hours I developed red welts/hives that are itchy and burn. I feel a restriction or not a relief when I take a deep breath and I have intermittent chest pain. 66 hours post vaccination and no symptoms have gone away
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Glossitis, Laryngeal inflammation, Pharyngeal inflammation, Pharyngeal swelling, Pruritus
Clinical narrative: Tongue, uvula, and felt like throat swelled within the first 15 minutes but not to a point that I couldn't breath. Tongue, uvula, and felt like throat have stayed inflamed. Within the next 18 hours I developed red welts/hives that are itchy and burn. I feel a restriction or not a relief when I take a deep breath and I have intermittent chest pain. 66 hours post vaccination and no symptoms have gone away
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Tongue, uvula, and felt like throat swelled within the first 15 minutes but not to a point that I couldn't breath. Tongue, uvula, and felt like throat have stayed inflamed. Within the next 18 hours I developed red welts/hives that are itchy and burn. I feel a restriction or not a relief when I take a deep breath and I have intermittent chest pain. 66 hours post vaccination and no symptoms have gone away
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: achy all over,back; achy all over,collar bone; achy all over,shoulders; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy all over,collar bone), BACK PAIN (achy all over,back) and ARTHRALGIA (achy all over,shoulders) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced MYALGIA (achy all over,collar bone), BACK PAIN (achy all over,back) and ARTHRALGIA (achy all over,shoulders). At the time of the report, MYALGIA (achy all over,collar bone), BACK PAIN (achy all over,back) and ARTHRALGIA (achy all over,shoulders) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Injection site bruising, Injection site pain, Injection site paraesthesia, Pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: Patient went to the hospital and said that at the hospital they told her that vaccine was given too high-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came in for second dose of Pfizer and said that when 1st shot was administered, it was given too high, causing arm pain, and pain radiating to chest.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Systemic: Patient went to the hospital and said that at the hospital they told her that vaccine was given too high-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient came in for second dose of Pfizer and said that when 1st shot was administered, it was given too high, causing arm pain, and pain radiating to chest.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Migraine, Pyrexia
Clinical narrative: Severe migraine; Chills; Fever of 101.4; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine), CHILLS (Chills) and PYREXIA (Fever of 101.4) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced MIGRAINE (Severe migraine), CHILLS (Chills) and PYREXIA (Fever of 101.4). At the time of the report, MIGRAINE (Severe migraine) outcome was unknown and CHILLS (Chills) and PYREXIA (Fever of 101.4) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 (High) fever of 101.4.         Patient took the second dose of moderna shot and within couple of hours  No concomitant and treatment medications were provided   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Right arm was warm; Itchy; Red; Rash; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Right arm was warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision (lymph node removed from her right arm 15 years ago) and Lymph node excision (also got her lymph node removed from her left arm part of her breast cancer) in June 2021. Concurrent medical conditions included Breast cancer.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Right arm was warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (Right arm was warm) and VACCINATION SITE SWELLING (Swollen) outcome was unknown and VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Rash) had not resolved.            No concomitant medications information was reported. Patient used ice to treat her symptoms  Patient use a soap, regularly as it was recommended by her doctor due to her breast cancer.  .
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Might have had a little bit of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Might have had a little bit of diarrhea) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Might have had a little bit of diarrhea). At the time of the report, DIARRHOEA (Might have had a little bit of diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient wanted to mention he had no signs and symptoms of covid or never tested positive for covid . Stated that Might have had a little bit of diarrhea, can not be remembered for sure.  HCP has scheduled a colonoscopy.  Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-319630 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination complication
Clinical narrative: Typical post vaccination side effects; Son accidentally vaccinated at age 17; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Typical post vaccination side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Son accidentally vaccinated at age 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia and Premature ventricular contractions.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION COMPLICATION (Typical post vaccination side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Son accidentally vaccinated at age 17). At the time of the report, VACCINATION COMPLICATION (Typical post vaccination side effects) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Son accidentally vaccinated at age 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: ongoing menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (ongoing menstrual cycle) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (ongoing menstrual cycle). At the time of the report, HEAVY MENSTRUAL BLEEDING (ongoing menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient informed that She is on birth control and has a very regular cycle. No treatment information was provided by the reporter. No Concomitant medicines were reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: it's been more than 35 days since caller got the first dose and still does not have the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it's been more than 35 days since caller got the first dose and still does not have the second) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been more than 35 days since caller got the first dose and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it's been more than 35 days since caller got the first dose and still does not have the second) had resolved.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Patient wants to get the second dose of the Moderna COVID-19 vaccine, but patient lost the appointment for the second. It was reported that patient had to wait to start all over again.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Swelling
Clinical narrative: Intense pain under my left eyebrow; swelling in the blood vessels going to my left eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Intense pain under my left eyebrow) and SWELLING (swelling in the blood vessels going to my left eye) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Intense pain under my left eyebrow) and SWELLING (swelling in the blood vessels going to my left eye). At the time of the report, EYE PAIN (Intense pain under my left eyebrow) and SWELLING (swelling in the blood vessels going to my left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  After Vaccination with Moderna  patient went on a flight and experienced intense pain under my left eyebrow and swelling in the blood vessels going to my left eye as the plane went up and again while in decent.   Reporter did not allow further contact
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after improper storage and handling/a predrawn syringe that was left out for 24-36 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported   No treatment medication was reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: he hasn't gotten the second one yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he hasn't gotten the second one yet.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he hasn't gotten the second one yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he hasn't gotten the second one yet.) had resolved.            No Concomitant medications were reported. No Treatment medications were reported.  He had an underlying condition.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: memory loss; shortness of breath; feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation; arm hurts; headache; heart keeps racing; heart rate is really high; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss), DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart rate is really high), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation) and PAIN IN EXTREMITY (arm hurts) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ischemia. Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, ALPRAZOLAM, ALPRAZOLAM (XANAX) and FLUOXETINE for an unknown indication.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced HEART RATE INCREASED (heart rate is really high) and PALPITATIONS (heart keeps racing). On an unknown date, the patient experienced AMNESIA (memory loss), DYSPNOEA (shortness of breath), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation), PAIN IN EXTREMITY (arm hurts) and HEADACHE (headache). At the time of the report, AMNESIA (memory loss), PAIN IN EXTREMITY (arm hurts) and HEADACHE (headache) outcome was unknown and DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart rate is really high), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation) and PALPITATIONS (heart keeps racing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes Hydrochlorizone , stomach pill as concomitant medication for unknown indication. Patient also take sucralaste for esophagus. Patient took Goodies Powder as treatment.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal pain, Pain in extremity, Palpitations
Clinical narrative: memory loss; shortness of breath; feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation; arm hurts; headache; heart keeps racing; heart rate is really high; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory loss), DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart rate is really high), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation) and PAIN IN EXTREMITY (arm hurts) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ischemia. Concomitant products included CLONIDINE, LOSARTAN, AMLODIPINE, ALPRAZOLAM, ALPRAZOLAM (XANAX) and FLUOXETINE for an unknown indication.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced HEART RATE INCREASED (heart rate is really high) and PALPITATIONS (heart keeps racing). On an unknown date, the patient experienced AMNESIA (memory loss), DYSPNOEA (shortness of breath), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation), PAIN IN EXTREMITY (arm hurts) and HEADACHE (headache). At the time of the report, AMNESIA (memory loss), PAIN IN EXTREMITY (arm hurts) and HEADACHE (headache) outcome was unknown and DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart rate is really high), OESOPHAGEAL PAIN (feels in her esophagus (in the middle of her chest) down to her stomach a burning sensation) and PALPITATIONS (heart keeps racing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient takes Hydrochlorizone , stomach pill as concomitant medication for unknown indication. Patient also take sucralaste for esophagus. Patient took Goodies Powder as treatment.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression, High cholesterol, Vaginal dryness, Weight loss, Falling and Gallbladder removal. Concurrent medical conditions included Multiple sclerosis, Optic neuritis, Blood pressure high, Dysarthria (Takes a little longer to pronounce words.), Hypothyroidism, Gastrooesophageal reflux disease, COPD, Iron low, Drug allergy (Allergic to prednisolone), Drug allergy (Allergic to mobic), Fruit allergy (Allergic to strawberry) and Pain. Concomitant products included HYDROXYZINE, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), METHYLPREDNISOLONE (MEDROL DOSEPAK), AMLODIPINE, LOSARTAN, LEVOTHYROXINE, TRAMADOL, ATOMOXETINE, OMEPRAZOLE, ESCITALOPRAM, GABAPENTIN, SIMVASTATIN, ACETYLSALICYLIC ACID (BREOPRIN), ESTRADIOL (VIVELLE DOT), FISH OIL (OMEGA 3 FISH OILS), ALBUTEROL [SALBUTAMOL] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced RASH (Severe rash). At the time of the report, RASH (Severe rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. Concomitant medication include unknown cream.  Patient current condition include use of assistive device and trouble remembering.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Pruritus, Vaccination site pruritus
Clinical narrative: Face and eyes started itching; Face and eyes started itching; Injection site itched a little bit; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Face and eyes started itching), PRURITUS (Face and eyes started itching) and VACCINATION SITE PRURITUS (Injection site itched a little bit) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EYE PRURITUS (Face and eyes started itching), PRURITUS (Face and eyes started itching) and VACCINATION SITE PRURITUS (Injection site itched a little bit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 02-Sep-2021, EYE PRURITUS (Face and eyes started itching), PRURITUS (Face and eyes started itching) and VACCINATION SITE PRURITUS (Injection site itched a little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on birth control medication as an concomitant medication.  Other treatment medication include steroid cream when patient went to ER room.  After 30 minute patient face and eyes started itching. Injection site also itched a little bit. One of the HCP in the vaccination site asked patient to open their mouth and could not see patient's tonsils.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Epistaxis, Fatigue, Headache, Illness
Clinical narrative: 8 bloody noses; headaches; extremely tired; really sick; consumer reports feeling stuffy and like someone is stepping on chest; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), EPISTAXIS (8 bloody noses), CHEST DISCOMFORT (consumer reports feeling stuffy and like someone is stepping on chest), HEADACHE (headaches) and FATIGUE (extremely tired) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced ILLNESS (really sick), HEADACHE (headaches) and FATIGUE (extremely tired). On 10-Sep-2021, the patient experienced EPISTAXIS (8 bloody noses). In September 2021, the patient experienced CHEST DISCOMFORT (consumer reports feeling stuffy and like someone is stepping on chest). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (really sick), EPISTAXIS (8 bloody noses), CHEST DISCOMFORT (consumer reports feeling stuffy and like someone is stepping on chest), HEADACHE (headaches) and FATIGUE (extremely tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided .  Patient did not have allergic reaction. Consumer stated that she was taking ibuprofen and Tylenol to alleviate the adverse events, but it does not help. It only helps with headaches for couple of hours. Consumer reports all the possible adverse events are still ongoing and none of them have subsided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Skin exfoliation, Skin reaction
Clinical narrative: palms were peeling fine layers of skin; had a delayed reaction; Out of exhaustion she fell asleep; she was freezing for 3 hours.; she broke into profuse sweating for 2 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (she was freezing for 3 hours.), HYPERHIDROSIS (she broke into profuse sweating for 2 hours), SKIN EXFOLIATION (palms were peeling fine layers of skin), SKIN REACTION (had a delayed reaction) and FATIGUE (Out of exhaustion she fell asleep) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced FEELING COLD (she was freezing for 3 hours.), HYPERHIDROSIS (she broke into profuse sweating for 2 hours), SKIN REACTION (had a delayed reaction) and FATIGUE (Out of exhaustion she fell asleep). On 12-Jun-2021, the patient experienced SKIN EXFOLIATION (palms were peeling fine layers of skin). On 11-Jun-2021, FEELING COLD (she was freezing for 3 hours.), HYPERHIDROSIS (she broke into profuse sweating for 2 hours) and FATIGUE (Out of exhaustion she fell asleep) had resolved. On 12-Jun-2021, SKIN EXFOLIATION (palms were peeling fine layers of skin) and SKIN REACTION (had a delayed reaction) had resolved.            No concomitant medication details were provided. No treatment medication details were provided.  The patient had no itching, no redness, just peeling.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: soreness of arm; soreness around the shot area; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of arm) and VACCINATION SITE PAIN (soreness around the shot area) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031L20A) for COVID-19 vaccination.     No Medical history was provided.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of arm) and VACCINATION SITE PAIN (soreness around the shot area). At the time of the report, MYALGIA (soreness of arm) and VACCINATION SITE PAIN (soreness around the shot area) outcome was unknown.            Concomitants included Multivitamins once dialy Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: typical post vaccination side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (typical post vaccination side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (typical post vaccination side effects). At the time of the report, VACCINATION COMPLICATION (typical post vaccination side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm pit area started hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm pit area started hurting) 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 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced VACCINATION SITE PAIN (left arm pit area started hurting). At the time of the report, VACCINATION SITE PAIN (left arm pit area started hurting) outcome was unknown.      No concomitant information was reported. No treatment information was reported.