chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Inappropriate schedule of product administration; Stated she had a very painful night; Is running a fever of 102; She's got a dropping headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Stated she had a very painful night), PYREXIA (Is running a fever of 102), HEADACHE (She's got a dropping headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Caller also stated that on 19 November 2021 she received a flu shot in her left arm.) on 19-Nov-2021. Past adverse reactions to the above products included No adverse reaction with Flu shot.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (Stated she had a very painful night), PYREXIA (Is running a fever of 102) and HEADACHE (She's got a dropping headache). On 22-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. At the time of the report, MYALGIA (Stated she had a very painful night), PYREXIA (Is running a fever of 102) and HEADACHE (She's got a dropping headache) outcome was unknown.      First dose of Johnson and Johnson received on 8April2021, Lot: 203A21A.  Patient received the booster dose yesterday on 22Nov2021 about noon, and stated she had a very painful night and is running a fever of 102, and she's got a dropping headache.  No relevant concomitant medications was reported. Treatment information was not provided.  Company Comment : This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced non serious, expected events of myalgia, headache and pyrexia. The events occurred on an unknown date after the third dose of mRNA-1273 vaccine. Patient received first dose of Johnson and Johnson COVID 19 vaccine on 8- April- 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced non serious, expected events of myalgia, headache and pyrexia. The events occurred on an unknown date after the third dose of mRNA-1273 vaccine. Patient received first dose of Johnson and Johnson COVID 19 vaccine on 8- April- 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of BACK PAIN (severe backpain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (severe backpain). At the time of the report, BACK PAIN (severe backpain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BACK PAIN (severe backpain) to be possibly related.    No concomitant medication reported.  No treatment information was provided.  Patient was having severe backpain and the doctor said it's from the vaccine
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Rash, Swelling
Clinical narrative: swelling; discomfort; breaking out of her skin; breaking out of her skin/skin break out from her shoulder to her hips; lymph node under her arm swelled like there is a large orange on her armpit.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), DISCOMFORT (discomfort), RASH (breaking out of her skin), RASH (breaking out of her skin/skin break out from her shoulder to her hips) and LYMPHADENOPATHY (lymph node under her arm swelled like there is a large orange on her armpit.) in a 77-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 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced SWELLING (swelling), DISCOMFORT (discomfort), RASH (breaking out of her skin), RASH (breaking out of her skin/skin break out from her shoulder to her hips) and LYMPHADENOPATHY (lymph node under her arm swelled like there is a large orange on her armpit.). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ISOPROPANOL, TANNIC ACID (IVY DRY) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), DISCOMFORT (discomfort), RASH (breaking out of her skin), RASH (breaking out of her skin/skin break out from her shoulder to her hips) and LYMPHADENOPATHY (lymph node under her arm swelled like there is a large orange on her armpit.) outcome was unknown.            No Concomitant Medication was provided.   This case was linked to MOD-2021-068579 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: got the booster dose from the expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got the booster dose from the expired vial) 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 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got the booster dose from the expired vial). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (got the booster dose from the expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   N concomitant medications was reported. No treatment drug details was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dehydration, Dizziness, Dyspnoea
Clinical narrative: COVID like symptoms; Lethargic; Extremely dehydrated; Fever; chills; Dizzy; felt weak; muscle twitches; Had a lot of mucus in throat/ mucus lingers.; making it difficult to breath; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID like symptoms), LETHARGY (Lethargic), DEHYDRATION (Extremely dehydrated), DIZZINESS (Dizzy) and ASTHENIA (felt weak) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (spent 16 days in quarantine) in March 2020. Concomitant products included TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Nov-2021, the patient experienced SUSPECTED COVID-19 (COVID like symptoms), LETHARGY (Lethargic), DEHYDRATION (Extremely dehydrated), PYREXIA (Fever) and CHILLS (chills). In November 2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (felt weak), MUSCLE TWITCHING (muscle twitches), SECRETION DISCHARGE (Had a lot of mucus in throat/ mucus lingers.) and DYSPNOEA (making it difficult to breath). At the time of the report, SUSPECTED COVID-19 (COVID like symptoms), LETHARGY (Lethargic), DEHYDRATION (Extremely dehydrated), DIZZINESS (Dizzy), ASTHENIA (felt weak), MUSCLE TWITCHING (muscle twitches), SECRETION DISCHARGE (Had a lot of mucus in throat/ mucus lingers.), DYSPNOEA (making it difficult to breath), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment- This spontaneous case concerns a 56-year-old male patient with relevant medical history of COVID-19, who experienced non-serious unexpected event of special interest (AESI) suspected COVID-19. The event occurred one day from the first dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.  Patient was taking 50,000 units of vitamin E weekly prior to taking the vaccine and was on that dose while the patient received the vaccine.  No treatment information was reported.; Sender's Comments: This spontaneous case concerns a 56-year-old male patient with relevant medical history of COVID-19, who experienced non-serious unexpected event of special interest (AESI) suspected COVID-19. The event occurred one day from the first dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Muscle twitching, Pyrexia, Secretion discharge, Suspected COVID-19
Clinical narrative: COVID like symptoms; Lethargic; Extremely dehydrated; Fever; chills; Dizzy; felt weak; muscle twitches; Had a lot of mucus in throat/ mucus lingers.; making it difficult to breath; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID like symptoms), LETHARGY (Lethargic), DEHYDRATION (Extremely dehydrated), DIZZINESS (Dizzy) and ASTHENIA (felt weak) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (spent 16 days in quarantine) in March 2020. Concomitant products included TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Nov-2021, the patient experienced SUSPECTED COVID-19 (COVID like symptoms), LETHARGY (Lethargic), DEHYDRATION (Extremely dehydrated), PYREXIA (Fever) and CHILLS (chills). In November 2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (felt weak), MUSCLE TWITCHING (muscle twitches), SECRETION DISCHARGE (Had a lot of mucus in throat/ mucus lingers.) and DYSPNOEA (making it difficult to breath). At the time of the report, SUSPECTED COVID-19 (COVID like symptoms), LETHARGY (Lethargic), DEHYDRATION (Extremely dehydrated), DIZZINESS (Dizzy), ASTHENIA (felt weak), MUSCLE TWITCHING (muscle twitches), SECRETION DISCHARGE (Had a lot of mucus in throat/ mucus lingers.), DYSPNOEA (making it difficult to breath), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment- This spontaneous case concerns a 56-year-old male patient with relevant medical history of COVID-19, who experienced non-serious unexpected event of special interest (AESI) suspected COVID-19. The event occurred one day from the first dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.  Patient was taking 50,000 units of vitamin E weekly prior to taking the vaccine and was on that dose while the patient received the vaccine.  No treatment information was reported.; Sender's Comments: This spontaneous case concerns a 56-year-old male patient with relevant medical history of COVID-19, who experienced non-serious unexpected event of special interest (AESI) suspected COVID-19. The event occurred one day from the first dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (felt sick after second dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient developed illness (felt sick after second dose). At the time of the report, illness (felt sick after second dose) outcome unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-395796 (patient link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: 5 days since he been experiencing extreme fatigue/Extreme fatigue; For the first 2 days, he had low fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (5 days since he been experiencing extreme fatigue/Extreme fatigue), PYREXIA (For the first 2 days, he had low fever) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 031B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced FATIGUE (5 days since he been experiencing extreme fatigue/Extreme fatigue), PYREXIA (For the first 2 days, he had low fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever and Chills, at an unspecified dose and frequency. In November 2021, PYREXIA (For the first 2 days, he had low fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (5 days since he been experiencing extreme fatigue/Extreme fatigue) had not resolved.            No concomitant medications were reported.  The patient stated that it had been 5 days since experienced extreme fatigue and for the first 2 days, he had low fever and chills. He stated that the extreme fatigue was of concern and was kind hoping it would go away.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well; Having trouble with their elbows; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well) and ARTHRALGIA (Having trouble with their elbows) 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.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well) and ARTHRALGIA (Having trouble with their elbows). The patient was treated with PREDNISONE for Adverse event, at a dose of 2 weeks. At the time of the report, PAIN IN EXTREMITY (Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well) and ARTHRALGIA (Having trouble with their elbows) outcome was unknown.            No Concomitant medication was reported.     Patient reported that they recall their HCP saying had some immunosuppressive effects so they inquire when it would be ok to take the booster.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash) had resolved.            Concomitant medications were not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Lethargy, Oxygen saturation, Pain in extremity
Clinical narrative: Feels lethargic today; Soreness in his injection arm/ arm is still sore; shaking for a hour & a half; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore), LETHARGY (Feels lethargic today), TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-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 TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills). On 22-Nov-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore). On 23-Nov-2021, the patient experienced LETHARGY (Feels lethargic today). At the time of the report, PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore) had not resolved, LETHARGY (Feels lethargic today) outcome was unknown and TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate: 120 (High) hear rate was up to 120, which is normally in the 50s to low 60s. In November 2021, Oxygen saturation: 87 to 89 (Low) oxygen level was 87 to 89, which is normally 91 to 95..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Feels lethargic today; Soreness in his injection arm/ arm is still sore; shaking for a hour & a half; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore), LETHARGY (Feels lethargic today), TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-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 TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills). On 22-Nov-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore). On 23-Nov-2021, the patient experienced LETHARGY (Feels lethargic today). At the time of the report, PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore) had not resolved, LETHARGY (Feels lethargic today) outcome was unknown and TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate: 120 (High) hear rate was up to 120, which is normally in the 50s to low 60s. In November 2021, Oxygen saturation: 87 to 89 (Low) oxygen level was 87 to 89, which is normally 91 to 95..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They give expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They give expired vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They give expired vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (They give expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 11-Nov-2021.   Date(s) and time(S) vial was first punctured: 10 AM on 18-Nov-2021.   Date(s) of administration of vaccine on 19-Nov-2021.   The vial was stored in fridge post puncture. the vial was not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 2-3 hours  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient Revieved Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Revieved Expired Vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Revieved Expired Vaccine). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient Revieved Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Injection site was reported as left.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: booster doses (1 to each patient) to 2 patients who were less than then age of 18 years.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (booster doses (1 to each patient) to 2 patients who were less than then age of 18 years.) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (booster doses (1 to each patient) to 2 patients who were less than then age of 18 years.). On 22-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (booster doses (1 to each patient) to 2 patients who were less than then age of 18 years.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  Reporter has stated that to her knowledge this was the only dose the patients received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Body temperature, Oral mucosal blistering, Pyrexia, Trismus
Clinical narrative: On the top corner of the lip it feels like blisters inside,It's on both sides of my mouth, right on the top inside edge; Not sure what they are, if blisters or Canker Sores; Can't open mouth; Fever of 101 to 103/had temperature of 99; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (On the top corner of the lip it feels like blisters inside,It's on both sides of my mouth, right on the top inside edge), APHTHOUS ULCER (Not sure what they are, if blisters or Canker Sores), TRISMUS (Can't open mouth) and PYREXIA (Fever of 101 to 103/had temperature of 99) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 030L20A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and BP.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (Fever of 101 to 103/had temperature of 99). On 22-Nov-2021, the patient experienced ORAL MUCOSAL BLISTERING (On the top corner of the lip it feels like blisters inside,It's on both sides of my mouth, right on the top inside edge), APHTHOUS ULCER (Not sure what they are, if blisters or Canker Sores) and TRISMUS (Can't open mouth). On 21-Nov-2021, PYREXIA (Fever of 101 to 103/had temperature of 99) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (On the top corner of the lip it feels like blisters inside,It's on both sides of my mouth, right on the top inside edge), APHTHOUS ULCER (Not sure what they are, if blisters or Canker Sores) and TRISMUS (Can't open mouth) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 101 to 103 (High) Fever of 101 to 103. On 21-Nov-2021, Body temperature: 99 (High) Had temperature of 99.         Concomitant medication included blood pressure medication and cholesterol medication.  No treatment information was provided. Patient was not sure what they were, if blisters or canker sores.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: 5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident; some soreness in left arm, at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some soreness in left arm, at the injection site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93909) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In November 2021, the patient experienced VACCINATION SITE PAIN (some soreness in left arm, at the injection site). On 21-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident). On 21-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old child who received a booster dose of the Moderna COVID-19 vaccine by accident) had resolved. At the time of the report, VACCINATION SITE PAIN (some soreness in left arm, at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the five years old patient received a booster dose of the Moderna COVID-19 vaccine by accident on 21-Nov-2021. The patient was supposed to get the Pfizer pediatric vaccine first dose, but the HCP gave the patient, the Moderna COVID-19 booster dose of 0.25 ml as the patient's first dose.  No concomitant medications were reported.  No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Arm reactions; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm reactions) and PAIN IN EXTREMITY (Arm soreness) 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 LIMB DISCOMFORT (Arm reactions) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, LIMB DISCOMFORT (Arm reactions) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were given. No treatment information were given.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) outcome was unknown and CHILLS (Chills) had resolved.            No concomitant medications were provided.  No treatment medications were reported.  Patient experienced fever and chills with the second dose.   This case was linked to MOD-2021-396168 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CLONAZEPAM for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) at a dose of 75 mg and ATORVASTATIN CALCIUM (LIPITOR) at a dose of 80 mg. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant medication also included Alopatine 5 mg 2 a day. Treatment medications also included unspecified blood thinners.  The patient stated that it had it about July the first had a Stroke or June 26th, not sure.; Sender's Comments: This case concerns a 76 year-old, female patient with concomitant use of atorvastatin calcium, who experienced the serious unexpected AESI of Cerebrovascular accident. The event occurred approximately 4 months after the second dose of mRNA-1273 vaccine, exact date not provided. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The use of concomitant medication atorvastatin calcium and patient´s advanced age, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: arm reactions; arm soreness; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (arm reactions) and PAIN IN EXTREMITY (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (arm reactions) and PAIN IN EXTREMITY (arm soreness). At the time of the report, VACCINATION COMPLICATION (arm reactions) and PAIN IN EXTREMITY (arm soreness) 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.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) 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 medication reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Diarrhea; Incontinence of urine; Sweating; Aches and pains; 98.9 degree fever; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), URINARY INCONTINENCE (Incontinence of urine), HYPERHIDROSIS (Sweating), PAIN (Aches and pains) and PYREXIA (98.9 degree fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (two triple bypasses). Concurrent medical conditions included Cardiac disorder NOS. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL TARTRATE (LOPRESSOR), ISOSORBIDE MONONITRATE, ROSUVASTATIN CALCIUM (CRESTOR) and TAMSULOSIN HCL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced DIARRHOEA (Diarrhea), URINARY INCONTINENCE (Incontinence of urine), HYPERHIDROSIS (Sweating), PAIN (Aches and pains) and PYREXIA (98.9 degree fever). At the time of the report, DIARRHOEA (Diarrhea), URINARY INCONTINENCE (Incontinence of urine), HYPERHIDROSIS (Sweating), PAIN (Aches and pains) and PYREXIA (98.9 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Body temperature: 98.9 (High) 98.9 degree Celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  It was reported that the patient was not taking his regular medication because of these symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Diarrhea; Incontinence of urine; Sweating; Aches and pains; 98.9 degree fever; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), URINARY INCONTINENCE (Incontinence of urine), HYPERHIDROSIS (Sweating), PAIN (Aches and pains) and PYREXIA (98.9 degree fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (two triple bypasses). Concurrent medical conditions included Cardiac disorder NOS. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL TARTRATE (LOPRESSOR), ISOSORBIDE MONONITRATE, ROSUVASTATIN CALCIUM (CRESTOR) and TAMSULOSIN HCL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced DIARRHOEA (Diarrhea), URINARY INCONTINENCE (Incontinence of urine), HYPERHIDROSIS (Sweating), PAIN (Aches and pains) and PYREXIA (98.9 degree fever). At the time of the report, DIARRHOEA (Diarrhea), URINARY INCONTINENCE (Incontinence of urine), HYPERHIDROSIS (Sweating), PAIN (Aches and pains) and PYREXIA (98.9 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Body temperature: 98.9 (High) 98.9 degree Celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.  It was reported that the patient was not taking his regular medication because of these symptoms.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Swelling, Vaccination site pain
Clinical narrative: swelling in armpit; Passed out; fatigue; arm has been sore all time; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in armpit), LOSS OF CONSCIOUSNESS (Passed out), VACCINATION SITE PAIN (arm has been sore all time) and FATIGUE (fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (arm has been sore all time). On 19-Nov-2021, the patient experienced SWELLING (swelling in armpit), LOSS OF CONSCIOUSNESS (Passed out) and FATIGUE (fatigue). On 19-Nov-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, SWELLING (swelling in armpit) and VACCINATION SITE PAIN (arm has been sore all time) had not resolved and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  Company comment: This is a Spontaneous case concerning a 23-year-old, male patient with unknown medical history, who experienced the unexpected non serious event of loss of consciousness. The event occurred approximately one day after the first dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 23-year-old, male patient with unknown medical history, who experienced the unexpected non serious event of loss of consciousness. The event occurred approximately one day after the first dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: became sick with covid-19. Their taste changed, they tasted everything sweet had chills and was shaking a lot like they had a venom inside them it was very weird; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (became sick with covid-19. Their taste changed, they tasted everything sweet had chills and was shaking a lot like they had a venom inside them it was very weird) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced COVID-19 (became sick with covid-19. Their taste changed, they tasted everything sweet had chills and was shaking a lot like they had a venom inside them it was very weird) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (became sick with covid-19. Their taste changed, they tasted everything sweet had chills and was shaking a lot like they had a venom inside them it was very weird) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included high blood pressure medication for an unknown indication.  It was reported that their taste changed, they tasted everything sweet had chills and was shaking a lot like they had a venom inside them it was very weird so after 5 days they went to the hospital on the 30-Mar-2021 and got tested and received antibody treatment and after 8 days they were released. They were advised to not take the second dose then but know they wonder where can they get another dose to continue being protected.  Company Comment: This spontaneous case concerns a 62-year-old female patient with no relevant medical history who experienced serious unexpected event of special interest (AESI) COVID-19. The event occurred approximately 15 days after the first dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to nature of the event and no information on the second dose, no rechallenge was done and thus, recurrence was not applicable. The benefit-risk relationship of the product is not affected by this report; Sender's Comments: This spontaneous case concerns a 62-year-old female patient with no relevant medical history who experienced serious unexpected event of special interest (AESI) COVID-19. The event occurred approximately 15 days after the first dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to nature of the event and no information on the second dose, no rechallenge was done and thus, recurrence was not applicable. The benefit-risk relationship of the product is not affected by this report
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 004M21A) for COVID-19 immunization. No medical history reported. On Jan 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 27, 2021, patient had a headache. Patient treated with Tylenol (paracetamol) on Jan 27, 2021 for headache, at an unspecified dose and frequency. On Jan 28, 2021, headache resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medication. This case linked to MOD-2021-396060, MOD-2021-396061 (patient link). Most recent follow-up information incorporated: On Nov 26, 2021: Follow-up received contained non-significant information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: he felt like he had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (he felt like he had the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (he felt like he had the flu). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Flu like symptoms, at a dose of 1 dosage form. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (he felt like he had the flu) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-396043, MOD-2021-396061 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Include no new information.