chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: DIDN'T END UP WELL; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose number series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced didn't end up well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of didn't end up well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Illness, Pyrexia
Clinical narrative: SORE; VIRTUALLY IN BED; SPIKED A 103 FEVER FOR 2 DAYS/ FEVERISH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the patient experienced sore, virtually in bed, and spiked a 103 fever for 2 days/ feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spiked a 103 fever for 2 days/ feverish, sore and virtually in bed was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE RELATED INJURY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination(dose series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine related injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine related injury was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: SMALL PLAQUE PSORIASIS FLARE-UP; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On an unspecified date, the patient experienced small plaque psoriasis flare-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small plaque psoriasis flare-up. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.). At the time of the report, ACCIDENTAL OVERDOSE (Gave a patient a full dose of 0.5 mL instead of a 0.25 mL booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-404722 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Feeling abnormal, Vaccination site pain
Clinical narrative: feeling really hard; Can't get up; so much pain in armpit, on site of injection; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really hard), DYSSTASIA (Can't get up) and VACCINATION SITE PAIN (so much pain in armpit, on site of injection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced FEELING ABNORMAL (feeling really hard), DYSSTASIA (Can't get up) and VACCINATION SITE PAIN (so much pain in armpit, on site of injection). At the time of the report, FEELING ABNORMAL (feeling really hard), DYSSTASIA (Can't get up) and VACCINATION SITE PAIN (so much pain in armpit, on site of injection) had not resolved.            Concomitant medications were not reported. Treatment medications were not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arms; Feels achy all over; Low grade fever of 100.3 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms), MYALGIA (Feels achy all over) and PYREXIA (Low grade fever of 100.3 degrees) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 007B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (Sore arms), MYALGIA (Feels achy all over) and PYREXIA (Low grade fever of 100.3 degrees). At the time of the report, PAIN IN EXTREMITY (Sore arms) was resolving and MYALGIA (Feels achy all over) and PYREXIA (Low grade fever of 100.3 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 100.3 (High) Low grade fever, 100.3 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood glucose, Fatigue, Hyperglycaemia
Clinical narrative: After the second dose her blood sugar sky rotted over 300; Became weaker/it linger; Lot of pain in the joint of her leg; Extremely fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (After the second dose her blood sugar sky rotted over 300), ASTHENIA (Became weaker/it linger), ARTHRALGIA (Lot of pain in the joint of her leg) and FATIGUE (Extremely fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-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 HYPERGLYCAEMIA (After the second dose her blood sugar sky rotted over 300), ASTHENIA (Became weaker/it linger), ARTHRALGIA (Lot of pain in the joint of her leg) and FATIGUE (Extremely fatigue). At the time of the report, HYPERGLYCAEMIA (After the second dose her blood sugar sky rotted over 300), ASTHENIA (Became weaker/it linger), ARTHRALGIA (Lot of pain in the joint of her leg) and FATIGUE (Extremely fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) Blood sugar over 300.   It was reported that patient increased her insulin intake by 6 units since the second dose as her blood-sugar level was over 300. Patient stated she took lots medication.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow-up received on 03-Dec-2021 contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine was given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Flu growed intensely; Intense diarrhea for over 3 weeks; Swelling  in the injection site growed intensely; Pain in the injection site growed intensely; Body ache growed intensely; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu growed intensely), DIARRHOEA (Intense diarrhea for over 3 weeks), VACCINATION SITE SWELLING (Swelling  in the injection site growed intensely), VACCINATION SITE PAIN (Pain in the injection site growed intensely) and MYALGIA (Body ache growed intensely) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and COPD. Concomitant products included AMLODIPINE and AMLODIPINE BESILATE, VALSARTAN (AMLOSARTAN [AMLODIPINE BESILATE;VALSARTAN]) for Blood pressure.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced INFLUENZA (Flu growed intensely), DIARRHOEA (Intense diarrhea for over 3 weeks), VACCINATION SITE SWELLING (Swelling  in the injection site growed intensely), VACCINATION SITE PAIN (Pain in the injection site growed intensely) and MYALGIA (Body ache growed intensely). At the time of the report, INFLUENZA (Flu growed intensely), DIARRHOEA (Intense diarrhea for over 3 weeks), VACCINATION SITE SWELLING (Swelling  in the injection site growed intensely), VACCINATION SITE PAIN (Pain in the injection site growed intensely) and MYALGIA (Body ache growed intensely) had not resolved.            Patient taken steroids for COPD Ammonium for two weeks to treat the diarrhea.   This case was linked to MOD-2021-404104 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have left arm pain which radiates to left breast. Pain gets worse with using arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I have left arm pain which radiates to left breast. Pain gets worse with using arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 028L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have left arm pain which radiates to left breast. Pain gets worse with using arm). At the time of the report, PAIN IN EXTREMITY (I have left arm pain which radiates to left breast. Pain gets worse with using arm) had not resolved.            No concomitant medication was provided by the reporter.  No treatment information was provided. The patient experienced left arm pain that radiated to the left breast.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The vial was initially stored in the refrigerator 29 Nov 2021.On 30 Nov 2021 at 8:21am vial was first punctured. The vial stored post puncture at room temperature. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius or 46 to 77 degree Fahrenheit) is 14 hours.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Feeding disorder, Pyrexia
Clinical narrative: Could not eat anything; Could not get off toilet because weak; Temperature of 100.6; Achy by the hip; In bed all day sleeping; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (In bed all day sleeping), FEEDING DISORDER (Could not eat anything), ASTHENIA (Could not get off toilet because weak), PYREXIA (Temperature of 100.6) and ARTHRALGIA (Achy by the hip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No medication history information was provided.  Previously administered products included for Product used for unknown indication: Johnson and Johnson (Received the Johnson and Johnson regular dose for the primary series in April 2021.) until April 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concomitant products included ATENOLOL, AMLODIPINE, FOLIC ACID, LEVOTHYROXINE and SULFASALAZINE for an unknown indication.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced SOMNOLENCE (In bed all day sleeping). On 30-Nov-2021, the patient experienced FEEDING DISORDER (Could not eat anything), ASTHENIA (Could not get off toilet because weak), PYREXIA (Temperature of 100.6) and ARTHRALGIA (Achy by the hip). At the time of the report, SOMNOLENCE (In bed all day sleeping), FEEDING DISORDER (Could not eat anything), ASTHENIA (Could not get off toilet because weak), PYREXIA (Temperature of 100.6) and ARTHRALGIA (Achy by the hip) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, Body temperature: 100.6 (High) 100.6.         No treatment medications were provided.  Reporter stated that his daughter also received the vaccine, and did not have any symptoms.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Could not eat anything; Could not get off toilet because weak; Temperature of 100.6; Achy by the hip; In bed all day sleeping; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (In bed all day sleeping), FEEDING DISORDER (Could not eat anything), ASTHENIA (Could not get off toilet because weak), PYREXIA (Temperature of 100.6) and ARTHRALGIA (Achy by the hip) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No medication history information was provided.  Previously administered products included for Product used for unknown indication: Johnson and Johnson (Received the Johnson and Johnson regular dose for the primary series in April 2021.) until April 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concomitant products included ATENOLOL, AMLODIPINE, FOLIC ACID, LEVOTHYROXINE and SULFASALAZINE for an unknown indication.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced SOMNOLENCE (In bed all day sleeping). On 30-Nov-2021, the patient experienced FEEDING DISORDER (Could not eat anything), ASTHENIA (Could not get off toilet because weak), PYREXIA (Temperature of 100.6) and ARTHRALGIA (Achy by the hip). At the time of the report, SOMNOLENCE (In bed all day sleeping), FEEDING DISORDER (Could not eat anything), ASTHENIA (Could not get off toilet because weak), PYREXIA (Temperature of 100.6) and ARTHRALGIA (Achy by the hip) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, Body temperature: 100.6 (High) 100.6.         No treatment medications were provided.  Reporter stated that his daughter also received the vaccine, and did not have any symptoms.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Pain in extremity
Clinical narrative: She experienced achiness in legs; Weakness; Slight headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced achiness in legs), ASTHENIA (Weakness), HEADACHE (Slight headache) and MYALGIA (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031821A and 025B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, BENAZEPRIL, OXYBUTYNIN, OMEPRAZOLE, PRAVASTATIN and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (She experienced achiness in legs), ASTHENIA (Weakness), HEADACHE (Slight headache) and MYALGIA (Sore arm). At the time of the report, PAIN IN EXTREMITY (She experienced achiness in legs), ASTHENIA (Weakness), HEADACHE (Slight headache) and MYALGIA (Sore arm) had resolved.            No Treatment medication were reported.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A seven year old was inadvertently given a full dose of the Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A seven year old was inadvertently given a full dose of the Moderna vaccine) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A seven year old was inadvertently given a full dose of the Moderna vaccine). On 04-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A seven year old was inadvertently given a full dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: high blood pressure; Getting headaches also but not as intense/ mild headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and HEADACHE (Getting headaches also but not as intense/ mild headaches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 029L21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced HYPERTENSION (high blood pressure) and HEADACHE (Getting headaches also but not as intense/ mild headaches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (high blood pressure) outcome was unknown and HEADACHE (Getting headaches also but not as intense/ mild headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood pressure measurement: high (High) high blood pressure.         No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Patient demographics, Vaccine dose details and Treatment medication were updated.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash erythematous, Swelling
Clinical narrative: red hive like rash that has begun to spread,The rash is most severe on the knees and behind the knees,; accompanied by swelling; are bruise like lesions on the back of her knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red hive like rash that has begun to spread,The rash is most severe on the knees and behind the knees,), SWELLING (accompanied by swelling) and CONTUSION (are bruise like lesions on the back of her knee) 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 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 25-Nov-2021, the patient experienced RASH ERYTHEMATOUS (red hive like rash that has begun to spread,The rash is most severe on the knees and behind the knees,), SWELLING (accompanied by swelling) and CONTUSION (are bruise like lesions on the back of her knee). At the time of the report, RASH ERYTHEMATOUS (red hive like rash that has begun to spread,The rash is most severe on the knees and behind the knees,), SWELLING (accompanied by swelling) and CONTUSION (are bruise like lesions on the back of her knee) outcome was unknown.            No concomitant and treatment drugs were reported.  It was reported that his wife received her Moderna booster dose (50mcg) on Tuesday 16-Nov-2021.  On 25-Nov-2021, she began to develop a red hive like rash that had begun to spread rapidly across the body and was accompanied by swelling.  Reporter met with an allergist and they did not attribute the rashes to the vaccine so he thought this could be dropped.   This case was linked to MOD-2021-399702 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow up received contains significant information updated in inarrative supplement
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Steady increase of weight - gained 15 lbs after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Steady increase of weight - gained 15 lbs after 1st dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 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 WEIGHT INCREASED (Steady increase of weight - gained 15 lbs after 1st dose). At the time of the report, WEIGHT INCREASED (Steady increase of weight - gained 15 lbs after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) Increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided.  Treatment information was not provided.  Normal weight reported was 185 to 190 lbs. Patient had the second dose on Sep-2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Vascular injury
Clinical narrative: blood vessel issues in my foot,dark, blood looking area; like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (blood vessel issues in my foot,dark, blood looking area) and CONTUSION (like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FISH OIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), AMLODIPINE BESYLATE, TELMISARTAN and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced VASCULAR INJURY (blood vessel issues in my foot,dark, blood looking area) and CONTUSION (like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot). At the time of the report, VASCULAR INJURY (blood vessel issues in my foot,dark, blood looking area) and CONTUSION (like a bruise,size of a half dollar,from the sole of the foot running 3 inches along the foot) outcome was unknown.            Treatment information was not provided.  Patient walk around in the field for 3.5 hours and noticed a bruise-like discoloration on the inside of his left ankle. Two days later, he was walking for several hours at the mall with his wife and saw that the left side of his foot had a dark, bloody looking area.   He said that this bruise-like discoloration was only on his left foot and was about the size of a half dollar. It looks like blood vessel issues on his left foot. He says that it's on the sole of his foot and runs about 3 inches along the side of his foot. He has never had any situation like this in his legs or ankles before. Patient has stopped the baby aspirin since this issue started.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Malaise, SARS-CoV-2 test, Secretion discharge
Clinical narrative: could not breathe; The coughing and trouble breathing was due to mucus in my chest; coughing; the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (could not breathe), SECRETION DISCHARGE (The coughing and trouble breathing was due to mucus in my chest), COUGH (coughing) and MALAISE (the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced DYSPNOEA (could not breathe), SECRETION DISCHARGE (The coughing and trouble breathing was due to mucus in my chest), COUGH (coughing) and MALAISE (the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021). The patient was treated with AZITHROMYCIN for Adverse event, at a dose of UNK dosage form; BROMPHENIRAMINE for Cough, at a dose of UNK dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) for Adverse event, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (could not breathe), SECRETION DISCHARGE (The coughing and trouble breathing was due to mucus in my chest), COUGH (coughing) and MALAISE (the patient got very sick 2 days after receiving his Moderna Covid-19 vaccine/I got very sick on 4NOV2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-403097 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Urticaria chronic
Clinical narrative: chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her; headache; aches; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA CHRONIC (chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her), HEADACHE (headache) and PAIN (aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eczema.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced HEADACHE (headache) and PAIN (aches). In June 2021, the patient experienced URTICARIA CHRONIC (chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at an unspecified dose and frequency. In January 2021, HEADACHE (headache) and PAIN (aches) had resolved. At the time of the report, URTICARIA CHRONIC (chronic urticaria/hives/hives on the waistband of jeans and where a grocery bag rubs against her) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the reactions, patient went to an allergist and had done multiple of tests including thyroid tests.  Patient has a history of eczema and used to take allergy shots as a kid
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives after booster dose; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (hives after booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives after booster dose). At the time of the report, URTICARIA (hives after booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-403273, MOD-2021-403274, MOD-2021-402965 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot to the touch; she found a big round rash/one inch below where she got the injection; home because she was not feeling well; bed all day/had to lay on the couch; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (bed all day/had to lay on the couch), MALAISE (home because she was not feeling well), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE RASH (she found a big round rash/one inch below where she got the injection) 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 28-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced ASTHENIA (bed all day/had to lay on the couch). On 30-Nov-2021, the patient experienced MALAISE (home because she was not feeling well). On 01-Dec-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE RASH (she found a big round rash/one inch below where she got the injection). At the time of the report, ASTHENIA (bed all day/had to lay on the couch) had not resolved and MALAISE (home because she was not feeling well), VACCINATION SITE WARMTH (hot to the touch) and VACCINATION SITE RASH (she found a big round rash/one inch below where she got the injection) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Mouth ulceration, Pyrexia, Stomatitis
Clinical narrative: mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer; they are really inflamed; sweating; fever; chills; This spontaneous case was reported by a pharmacist and describes the occurrence of MOUTH ULCERATION (mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer), STOMATITIS (they are really inflamed), HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 014M21A and 046A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills). On 29-Nov-2021, the patient experienced MOUTH ULCERATION (mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer) and STOMATITIS (they are really inflamed). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (mouth full of oral ulcers/lesions inside of his mouth/ irritated/looks like ulcer) and STOMATITIS (they are really inflamed) had not resolved and HYPERHIDROSIS (sweating), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy, Muscle spasms, Pain, Peripheral swelling
Clinical narrative: Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"; Crumps; Had crumps and pain and the reporter stated that it was even worse than the second dose; Arm is swollen; Had a fever before but now was gone; Lymph nodes under her arm and left side are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"), MUSCLE SPASMS (Crumps), CONDITION AGGRAVATED (Had crumps and pain and the reporter stated that it was even worse than the second dose), PERIPHERAL SWELLING (Arm is swollen) and PYREXIA (Had a fever before but now was gone) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PAIN (Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"), MUSCLE SPASMS (Crumps), CONDITION AGGRAVATED (Had crumps and pain and the reporter stated that it was even worse than the second dose), PERIPHERAL SWELLING (Arm is swollen), PYREXIA (Had a fever before but now was gone) and LYMPHADENOPATHY (Lymph nodes under her arm and left side are swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"), MUSCLE SPASMS (Crumps), CONDITION AGGRAVATED (Had crumps and pain and the reporter stated that it was even worse than the second dose), PERIPHERAL SWELLING (Arm is swollen) and LYMPHADENOPATHY (Lymph nodes under her arm and left side are swollen) had not resolved and PYREXIA (Had a fever before but now was gone) had resolved.            The reporter was calling on behalf of their daughter who was the patient and reported that post receiving the booster dose, the patient was swollen; their lymph nodes under their arm and left side were swollen, as well as their arm. The patient had a fever before but now was gone. Reportedly, the patient also had crumps and pain and the reporter stated that it was even worse than the second dose and it had been ongoing for almost two weeks. The pharmacist told them to use Benadryl, but the reporter stated that they've tried with Aspirin and other pills too.  The reporter also informed that the patient was born in 1981 and had 39 when they had their 2nd dose, and was 40 year old now.  No Concomitant product use was reported. Treatment medication reported also included some other pills for unknown indication.   This case was linked to MOD-2021-402764 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"; Crumps; Had crumps and pain and the reporter stated that it was even worse than the second dose; Arm is swollen; Had a fever before but now was gone; Lymph nodes under her arm and left side are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"), MUSCLE SPASMS (Crumps), CONDITION AGGRAVATED (Had crumps and pain and the reporter stated that it was even worse than the second dose), PERIPHERAL SWELLING (Arm is swollen) and PYREXIA (Had a fever before but now was gone) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PAIN (Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"), MUSCLE SPASMS (Crumps), CONDITION AGGRAVATED (Had crumps and pain and the reporter stated that it was even worse than the second dose), PERIPHERAL SWELLING (Arm is swollen), PYREXIA (Had a fever before but now was gone) and LYMPHADENOPATHY (Lymph nodes under her arm and left side are swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (Pain/It's even worse than the second dose and it's been ongoing for almost two weeks"), MUSCLE SPASMS (Crumps), CONDITION AGGRAVATED (Had crumps and pain and the reporter stated that it was even worse than the second dose), PERIPHERAL SWELLING (Arm is swollen) and LYMPHADENOPATHY (Lymph nodes under her arm and left side are swollen) had not resolved and PYREXIA (Had a fever before but now was gone) had resolved.            The reporter was calling on behalf of their daughter who was the patient and reported that post receiving the booster dose, the patient was swollen; their lymph nodes under their arm and left side were swollen, as well as their arm. The patient had a fever before but now was gone. Reportedly, the patient also had crumps and pain and the reporter stated that it was even worse than the second dose and it had been ongoing for almost two weeks. The pharmacist told them to use Benadryl, but the reporter stated that they've tried with Aspirin and other pills too.  The reporter also informed that the patient was born in 1981 and had 39 when they had their 2nd dose, and was 40 year old now.  No Concomitant product use was reported. Treatment medication reported also included some other pills for unknown indication.   This case was linked to MOD-2021-402764 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: not immunocompromised, but got full dose of booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose of booster) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 011A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose of booster). On 30-Nov-2021, ACCIDENTAL OVERDOSE (not immunocompromised, but got full dose of booster) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-402785 (Patient Link).