chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Bad case of hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Bad case of hives) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID 19 vaccine (Primary dose). Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID 19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Bad case of hives). The patient was treated with PREDNISONE for Hives, at a dose of 4 doses; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Bad case of hives) outcome was unknown.            No Concomitant medications were reported.  Two days after receiving the booster dose, patient started having a bad case of hives. The hives got worse each day. Patient had been taking antihistamines and steroid. Patient's father stated that he does not have his son's vaccination information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Pruritus, Rash
Clinical narrative: heart is pounding; itching; rash a little bit in her neck, rash in back; gets up and feels like she will pass out; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart is pounding), PRURITUS (itching), RASH (rash a little bit in her neck, rash in back) and DIZZINESS (gets up and feels like she will pass out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PALPITATIONS (heart is pounding), PRURITUS (itching), RASH (rash a little bit in her neck, rash in back) and DIZZINESS (gets up and feels like she will pass out). At the time of the report, PALPITATIONS (heart is pounding) had not resolved, PRURITUS (itching) and DIZZINESS (gets up and feels like she will pass out) outcome was unknown and RASH (rash a little bit in her neck, rash in back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. Patient took an unknown medication for rash and no treatment information was provided for other reported events.  Patient stated, after first dose she had symptoms, she thought they will go away but they was still here. Her heart was pounding, this was not normal. She never had a heart problem. She was due her second shot on 05-Jan-2022 but she did not know if she should get it. She also had a rash, a little bit in her neck and back. She put medication and it went away. Also had itching. She gets up and feels like she will pass out.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: uncomfortable to sleep; left arm was sore to raise above shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (uncomfortable to sleep) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced SLEEP DISORDER (uncomfortable to sleep) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder). At the time of the report, SLEEP DISORDER (uncomfortable to sleep) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder) was resolving.            Reported approx.6 hours post vaccine, left arm was sore to raise above shoulder and uncomfortable to sleep on. It has been reported feels better wed am. No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphatic leukemia.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (minor sore arm). At the time of the report, PAIN IN EXTREMITY (minor sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-433338, MOD-2021-408990.
Sex: U
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance
Clinical narrative: Dysautonomic reaction when treated with mRNA 1273 (Dose 1); This spontaneous case was reported by a consumer and describes the occurrence of AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomic reaction when treated with mRNA 1273 (Dose 1)) 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 AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomic reaction when treated with mRNA 1273 (Dose 1)). At the time of the report, AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomic reaction when treated with mRNA 1273 (Dose 1)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported No treatment medication reported  It was reported that on 05-DEC-2021 patient received covid-19 vaccine ad.26. cov2,s.(Janssen).  Dose number, route of administration and batch number was not reported. Indication was reported as prophylactic vaccination. Action taken with drug was reported as not applicable and dechallenge and rechallenge  also not applicable.  Patient reported that on 05-Dec-2021 had lab test includes heart rate increased (225).  Patient had adverse event after Janssen vaccine included woke up with heart rate of 225 (recovering/resolving), mild chest pain (not recovered), entire body cold (recovering/resolving) and entire body numbness (recovering/resolving).  Reporter and company causality for Janssen vaccine was reported as possible.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (minor sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia lymphocytic chronic.   On 26-Mar-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 PAIN IN EXTREMITY (minor sore arm). At the time of the report, PAIN IN EXTREMITY (minor sore arm) outcome was unknown. Not Provided   No concomitant information provided. No treatment information provided  This case was linked to MOD-2021-433326, MOD-2021-408990.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She had a slight sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a slight sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (She had a slight sore arm). In February 2021, PAIN IN EXTREMITY (She had a slight sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2021-433634.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lump on chest; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump on chest) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 22-Sep-2020, the patient started TREPROSTINIL SODIUM (Subcutaneous) 5.0 mg/ml. 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 MASS (Lump on chest). At the time of the report, MASS (Lump on chest) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided. current dose was reported as 0.0594 µg/kg for Treprostinil sodium..
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a slight sore arm that did not even last 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a slight sore arm that did not even last 1 day) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Had a slight sore arm that did not even last 1 day). In March 2021, PAIN IN EXTREMITY (Had a slight sore arm that did not even last 1 day) had resolved.            Patient had a slight sore arm that did not even last 1 day after both the first and second dose.  No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-433404, MOD-2021-433638 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic reaction to polyethylene glycol when treated with mRNA 1273; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to polyethylene glycol when treated with mRNA 1273) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    Concurrent medical conditions included Drug allergy (Lidocaine) and Nonsmoker.   On 09-Dec-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. 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 ALLERGY TO VACCINE (Allergic reaction to polyethylene glycol when treated with mRNA 1273). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to polyethylene glycol when treated with mRNA 1273) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is non alcoholic and non drug user.  No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient received Janssen COVID-19 vaccine on 09-DEC-2021 and  on 10-DEC-2021 experienced dull stomach pain and upper abdominal pain with the outcome not recovered and not resolved with possible causality assessment given by reporter and Mfr. vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (an issue that happens when they vaccinated a person) 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 (an issue that happens when they vaccinated a person). At the time of the report, VACCINATION COMPLICATION (an issue that happens when they vaccinated a person) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 19-Nov-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1)). At the time of the report, VACCINATION COMPLICATION (Following vaccination with mRNA 1273 , the patient had weird side effects (dose 1)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia
Clinical narrative: Pyrexia; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia) and DIZZINESS (dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Previously administered products included for Influenza: FLU (quadrivalent flu shot annually - historically without reaction). Past adverse reactions to the above products included Lymph node disorder with FLU. Concurrent medical conditions included Penicillin allergy (Hives) since 08-Jan-1991, Lactose intolerance (Abdominal pain) since 01-Jan-2017 and Undifferentiated connective tissue disease (as with prior two doses of vaccines, significant flare up.) since 1991.    On 12-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 11:00 PM, the patient experienced PYREXIA (Pyrexia). 12-Mar-2021 at 11:00 PM, the patient experienced DIZZINESS (dizziness). In 2021, PYREXIA (Pyrexia) and DIZZINESS (dizziness) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: abnormal (abnormal) 101 to 103 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  Patient weight was 175.  Patient stated that until her initial COVID vaccination, she never had a reaction to a vaccination her life   This case was linked to MOD-2021-404048, MOD-2021-404059.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling heavy), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Feeling tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 FEELING ABNORMAL (Feeling heavy), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Feeling tired). At the time of the report, FEELING ABNORMAL (Feeling heavy), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Feeling tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-433568, MOD-2021-433968 (Patient Link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia
Clinical narrative: shortness of breath; body ache; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (shortness of breath) and MYALGIA (body ache) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Previously administered products included for Drug use for unknown indication: Johnson and johnson. Past adverse reactions to the above products included No adverse event with Johnson and johnson. Concurrent medical conditions included Diabetes.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DYSPNOEA (shortness of breath) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath) and MYALGIA (body ache) outcome was unknown.            No Concomitant Drug details were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm after the 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-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 in the arm after the 1st dose). At the time of the report, PAIN IN EXTREMITY (soreness in the arm after the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient stated that her body usually reacts to things like that after she gets a flu shot and usually sits down for 30 minutes. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-433896 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in his left hand in his first four fingers thumb,patient takes a shower the tingling intensifies.), MUSCLE SPASMS (right arm to his elbow muscle spasms,occurs when the patients arm is at rest) and HEADACHE (mild headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced HEADACHE (mild headache). In 2021, the patient experienced MUSCLE SPASMS (right arm to his elbow muscle spasms,occurs when the patients arm is at rest). On 11-Jul-2021, the patient experienced PARAESTHESIA (tingling in his left hand in his first four fingers thumb,patient takes a shower the tingling intensifies.). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Headache, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in his left hand in his first four fingers thumb,patient takes a shower the tingling intensifies.) had not resolved, MUSCLE SPASMS (right arm to his elbow muscle spasms,occurs when the patients arm is at rest) outcome was unknown and HEADACHE (mild headache) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-434332 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow up document received contains No New information.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Parosmia, Taste disorder
Clinical narrative: experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes; After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.; After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes), TASTE DISORDER (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) and PAROSMIA (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 022C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced PARAESTHESIA (experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes), TASTE DISORDER (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) and PAROSMIA (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.). At the time of the report, PARAESTHESIA (experiencing tingling in his left arm fingers,The tingling in his right arm comes and goes), TASTE DISORDER (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) and PAROSMIA (After the booster dose the Patient reports that he can taste the vaccine and smell the vaccine.) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-434288.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up source document contains no new information. On 29-Dec-2021: Follow-up source document contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Vitreous floaters
Clinical narrative: eye pain, not able to move eyes from side to side that ended up with some floaters; eye pain, not able to move eyes from side to side that ended up with some floaters; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain, not able to move eyes from side to side that ended up with some floaters) and VITREOUS FLOATERS (eye pain, not able to move eyes from side to side that ended up with some floaters) 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 (eye pain, not able to move eyes from side to side that ended up with some floaters) and VITREOUS FLOATERS (eye pain, not able to move eyes from side to side that ended up with some floaters). At the time of the report, EYE PAIN (eye pain, not able to move eyes from side to side that ended up with some floaters) had resolved and VITREOUS FLOATERS (eye pain, not able to move eyes from side to side that ended up with some floaters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Vitreous floaters
Clinical narrative: Same eye pain happened again but this time much more pronounced; Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Same eye pain happened again but this time much more pronounced) and VITREOUS FLOATERS (Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Same eye pain happened again but this time much more pronounced) and VITREOUS FLOATERS (Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read). At the time of the report, EYE PAIN (Same eye pain happened again but this time much more pronounced) and VITREOUS FLOATERS (Eye floaters, so bad that had trouble reading as the floaters would settle in front of letters as was trying to read) was resolving.            No concomitant medication information was provided.  No treatment medication were provided.  It was reported that patient had trouble reading for three months as the floaters would settle in front of letters as patient was trying to read.   This case was linked to MOD-2021-434452.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (took the dose subcutaneous) 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) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (took the dose subcutenious). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (took the dose subcutenious) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI infection after first dose; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI infection after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI infection after first dose). The patient was treated with LEVOFLOXACIN ongoing since an unknown date for UTI, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (UTI infection after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  It was reported that, the patient was due for 2nd dose of Moderna vaccine on 11-Feb-2021 and his wife wanted to know if antibiotic interfere with vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: cold sore after first shot; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore after first shot) 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 ORAL HERPES (cold sore after first shot). At the time of the report, ORAL HERPES (cold sore after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug was reported.  No treatment drugs were reported.  The patient got an antiviral, valacyclovir, and was not t sure if it would affect the vaccine. She stated she never took the medication because she didn't want it to affect the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: tested positive for covid before, but still has the symptoms; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (tested positive for covid before, but still has the symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Diarrhea, Shortness of breath, Cough, Loss of taste, Loss of smell, Sore throat and Congestion nasal.    On 21-Jan-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 POST-ACUTE COVID-19 SYNDROME (tested positive for covid before, but still has the symptoms). At the time of the report, POST-ACUTE COVID-19 SYNDROME (tested positive for covid before, but still has the symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  It was reported that the patient received first dose of Moderna vaccine an hour ago in left arm.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye pain, Myalgia, Pyrexia
Clinical narrative: My eyes hurt; Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles; Fever of 101F for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (My eyes hurt), PYREXIA (Fever of 101F for 1 day) and MYALGIA (Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 vaccine (Patient had doses of the Pfizer Covid-19 vaccine) in April 2020. Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 vaccine.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever of 101F for 1 day). On 29-Dec-2021, the patient experienced EYE PAIN (My eyes hurt) and MYALGIA (Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 29-Dec-2021, PYREXIA (Fever of 101F for 1 day) had resolved. At the time of the report, EYE PAIN (My eyes hurt) and MYALGIA (Aching in my hand/aching in my elbow/aching in my back/I felt achy all over/I felt achy in my joints/I felt achy in my muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Body temperature: 101f (High) fever of 101F.         No Concomitant Products were reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea issues; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Diarrhea issues) 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 DIARRHOEA (Diarrhea issues). At the time of the report, DIARRHOEA (Diarrhea issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-435439, MOD-2021-435236 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: flight diarrhea; fatigue; nausea; light headache the first day, then stronger headache the following day; Had a sore arm later the day of the shot and it hurt more the next day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (flight diarrhea), HEADACHE (light headache the first day, then stronger headache the following day), VACCINATION SITE PAIN (Had a sore arm later the day of the shot and it hurt more the next day), FATIGUE (fatigue) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (light headache the first day, then stronger headache the following day) and VACCINATION SITE PAIN (Had a sore arm later the day of the shot and it hurt more the next day). On 30-Dec-2021, the patient experienced DIARRHOEA (flight diarrhea), FATIGUE (fatigue) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (flight diarrhea), HEADACHE (light headache the first day, then stronger headache the following day), VACCINATION SITE PAIN (Had a sore arm later the day of the shot and it hurt more the next day), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.   For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient state they do not take any medication regularly.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: severe headache ,headache wont go away,  still cannot get rid of the headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache ,headache wont go away,  still cannot get rid of the headache) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 030L20A and (0 or 3)11M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (severe headache ,headache wont go away,  still cannot get rid of the headache) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache ,headache wont go away,  still cannot get rid of the headache) had not resolved and CHILLS (chills) outcome was unknown.            Patient was taking oral medication for diabetes
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An HCP accidentally vaccinated a 16 year old with the Moderna COVID-19 vaccination) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An HCP accidentally vaccinated a 16 year old with the Moderna COVID-19 vaccination). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An HCP accidentally vaccinated a 16 year old with the Moderna COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has no concomitant medications.  Treatment information not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: unauthorized age received vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2nd dose) and PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine). On 15-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age received vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Migraine, Myalgia, Nausea
Clinical narrative: still sore; fever; nausea; achy all over; joint pain; Really bad reaction; felt horrible/She felt bad; Migraine 10/10; hot/still warm; hard/ It was initially hard as a rock; Her arm became red/ It is still red/still has a 4x5 inch mark; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm) and VACCINATION SITE INDURATION (hard/ It was initially hard as a rock) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (First shot, LOT- Ej1685, Intramuscular.) on 21-Dec-2020, Pfizer Vaccine (Second shot and LOT- EL1283) on 07-Jan-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine and Pfizer Vaccine.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain). On 30-Dec-2021, the patient experienced VACCINATION SITE PAIN (still sore). On 29-Dec-2021, VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark) and VACCINATION SITE PAIN (still sore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) She got a COVID test and it was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's weight was reported as  175 and units were not reported. No concomitant information was reported. Patient Tried to put heat and lots of steroid cream for events. Patient had stated that she still has a 4x5 inch mark in the left deltoid and initially it was hard as rock.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination complication, Vaccination site erythema, Vaccination site induration
Clinical narrative: still sore; fever; nausea; achy all over; joint pain; Really bad reaction; felt horrible/She felt bad; Migraine 10/10; hot/still warm; hard/ It was initially hard as a rock; Her arm became red/ It is still red/still has a 4x5 inch mark; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm) and VACCINATION SITE INDURATION (hard/ It was initially hard as a rock) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine (First shot, LOT- Ej1685, Intramuscular.) on 21-Dec-2020, Pfizer Vaccine (Second shot and LOT- EL1283) on 07-Jan-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine and Pfizer Vaccine.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain). On 30-Dec-2021, the patient experienced VACCINATION SITE PAIN (still sore). On 29-Dec-2021, VACCINATION COMPLICATION (Really bad reaction), FEELING ABNORMAL (felt horrible/She felt bad), MIGRAINE (Migraine 10/10), VACCINATION SITE INDURATION (hard/ It was initially hard as a rock), PYREXIA (fever), NAUSEA (nausea), MYALGIA (achy all over) and ARTHRALGIA (joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot/still warm), VACCINATION SITE ERYTHEMA (Her arm became red/ It is still red/still has a 4x5 inch mark) and VACCINATION SITE PAIN (still sore) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: negative (Negative) She got a COVID test and it was negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's weight was reported as  175 and units were not reported. No concomitant information was reported. Patient Tried to put heat and lots of steroid cream for events. Patient had stated that she still has a 4x5 inch mark in the left deltoid and initially it was hard as rock.