chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test, Vaccination site reaction
Clinical narrative: Severe reaction to vaccine at both injection site; Body aches; Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Severe reaction to vaccine at both injection site), MYALGIA (Body aches) and FATIGUE (Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Severe reaction to vaccine at both injection site), MYALGIA (Body aches) and FATIGUE (Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal). At the time of the report, VACCINATION SITE REACTION (Severe reaction to vaccine at both injection site), MYALGIA (Body aches) and FATIGUE (Extreme fatigue / Unable to function for 4 days then another 5 days to feel normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, SARS-CoV-2 test: positive (Positive) Patient received 1st Moderna vaccine on 5/7 just had rapid test and it was positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had COVID in the late December early January. No concomitant products were reported by reporter. No treatment medication provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia
Clinical narrative: No energy; Arm is sore; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), MYALGIA (Arm is sore) and ARTHRALGIA (Shoulder pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy), MYALGIA (Arm is sore) and ARTHRALGIA (Shoulder pain). At the time of the report, ASTHENIA (No energy), MYALGIA (Arm is sore) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported by reporter. No treatment medication provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Ligament sprain, Myalgia
Clinical narrative: Swollen ankles; in a lot of pain; sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks), JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B217) for COVID-19 vaccination.     Concurrent medical conditions included Foot drop (Left foot drop- started years ago) and Ankle instability (Ankle pops in and out). Concomitant products included TOFACITINIB CITRATE (XELJANZ XR), SERTRALINE HYDROCHLORIDE (SERTRALINE [SERTRALINE HYDROCHLORIDE]), SIMVASTATIN, CYCLOBENZAPRINE, DICLOFENAC SODIUM, LISINOPRIL, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), GABAPENTIN and METFORMIN HYDROCHLORIDE (METFORMIN ER) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks). On 10-Jun-2021, the patient experienced JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain). At the time of the report, LIGAMENT SPRAIN (sprained his left ankle / heard crack, crack, crack /went down like a ton of bricks), JOINT SWELLING (Swollen ankles) and MYALGIA (in a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis from 17-May-2021 to 27-May-2021 and Bronchitis from 17-May-2021 to 27-May-2021. Concurrent medical conditions included Allergy to arthropod sting, Latex allergy (allergy to Latex and Doxycycline), Drug allergy (Allergy to Biaxin), Hypertension since 04-Jun-2018, Depression since 04-Dec-2017 and Hyperlipidemia since 04-Dec-2017. Concomitant products included DICLOFENAC from 03-Mar-2019 to an unknown date for Chronic pain, SIMVASTATIN from 04-Dec-2017 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from 01-Mar-2020 to an unknown date for Hyperlipidemia, METOPROLOL from 01-Mar-2020 to an unknown date for Hypertension, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from 04-Dec-2017 to an unknown date for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she is allergic to TD and viozz. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received on 30 Jul 2021 contains patient demographics added, medical history, concomitant medication were added.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia oral, Taste disorder
Clinical narrative: bad taste in my mouth; sense of numbness in the left side of my mouth; Sense of  coldness in the left side of my mouth; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (bad taste in my mouth), HYPOAESTHESIA ORAL (sense of numbness in the left side of my mouth) and FEELING COLD (Sense of  coldness in the left side of my mouth) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (bad taste in my mouth), HYPOAESTHESIA ORAL (sense of numbness in the left side of my mouth) and FEELING COLD (Sense of  coldness in the left side of my mouth). At the time of the report, TASTE DISORDER (bad taste in my mouth), HYPOAESTHESIA ORAL (sense of numbness in the left side of my mouth) and FEELING COLD (Sense of  coldness in the left side of my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Skin fissures
Clinical narrative: She received her 1st dose back in January on 20JAN2021; Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand); itchiness all over my body; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021), SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) and PRURITUS (itchiness all over my body) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No medical history was provided.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021). 09-Jun-2021, the patient experienced SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) and PRURITUS (itchiness all over my body). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her 1st dose back in January on 20JAN2021) had resolved. On 10-Jun-2021, PRURITUS (itchiness all over my body) had resolved. At the time of the report, SKIN FISSURES (Chaffing on my fingertips (1st, 2nd and 3rd fingers of each hand)) had not resolved.            Concomitant product use was not reported.   It was reported  that the patient took an anti-histamine for treatment (not further specified) and the itching improved however, the chaffing is continuing. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Product dose omission issue
Clinical narrative: did notget the second shot of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine). The patient was treated with PREDNISONE ongoing from 10-Apr-2021 for Platelet count, at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (did notget the second shot of the Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Platelet count decreased: 12000 (Low) 12000. On an unknown date, Platelet count: 322,000 (Inconclusive) 322,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Skin lesion
Clinical narrative: red pigmented lesion ,first started at the injection arm( left arm); red pigmented lesion spread to the legs; red pigmented lesion spread to the other arm(right arm); This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)). At the time of the report, SKIN LESION (red pigmented lesion ,first started at the injection arm( left arm)), RASH ERYTHEMATOUS (red pigmented lesion spread to the legs) and RASH MACULAR (red pigmented lesion spread to the other arm(right arm)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.  No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow Up Appended. Added batch number. Patient route of administration updated. On 30-Jun-2021: Follow up received and contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Real bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Real bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Real bad headache). At the time of the report, HEADACHE (Real bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication- (not clear) for headache was reported. No concomitant medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Product dose omission issue
Clinical narrative: Missed Second Dose ( Beyond 42 days); Tired; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PRODUCT DOSE OMISSION ISSUE (Missed Second Dose ( Beyond 42 days)) and FATIGUE (Tired) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Second Dose ( Beyond 42 days)) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), PRODUCT DOSE OMISSION ISSUE (Missed Second Dose ( Beyond 42 days)) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: Tingling sensations; Rash on back of left leg after first moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot). At the time of the report, PARAESTHESIA (Tingling sensations) and RASH (Rash on back of left leg after first moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood urine present, Chills, Malaise
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of malaise (not feeling good), abdominal pain upper (cramps in stomach), bloody urine (blood in urine) and chills in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced malaise (not feeling good), abdominal pain upper (cramps in stomach), bloody urine (blood in urine) and chills. At the time of the report, malaise (not feeling good), abdominal pain upper (cramps in stomach), bloody urine (blood in urine) and chills outcome: unknown. Concomitant product use and treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (omprezole). Concomitant products included LEVOTHYROXINE for Hypothyroidism, BUPROPION for Mood disorder NOS, TESTOSTERONE, BECLOMETASONE DIPROPIONATE (QNASL) and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 15-Feb-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Cause of tinnitus provided as minor hearing loss.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 19-JUL-2021 and contains patient demographics added, relevant history updated, suspect drug details and lot number added, concomitant drugs added, adverse event details updated On 29-Jul-2021: Contained no new information.
Sex: U
Vaccine: COVID19
Symptoms: Allodynia, Bone pain
Clinical narrative: aggravate allodynia; bones hurting; This spontaneous case was reported by a consumer and describes the occurrence of ALLODYNIA (aggravate allodynia) and BONE PAIN (bones hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALLODYNIA (aggravate allodynia) and BONE PAIN (bones hurting).   At the time of the report, ALLODYNIA (aggravate allodynia) and BONE PAIN (bones hurting) outcome was unknown.   No concomitant medication was reported. Treatment medication was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection, Therapeutic response unexpected
Clinical narrative: I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now; unexpected beneficiary effect/Herpes Simplex outbreaks disappeared; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now) and THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant discontinuation syndrome, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, BOTULINUM TOXIN TYPE A (BOTOX) for Vocal cord dysfunction.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared). On 12-Jul-2021, the patient experienced HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now). On 13-Jul-2021, HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  She went 6 months herpes outbreak free but yesterday she had an out break she was so excited and now disappointed.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received on 13-Jul-2021. New event Herpes NOS added.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia oral, Pruritus, Pyrexia, Vaccination complication
Clinical narrative: lups (lips) tingling; Sick with fever; Itching all over; Severe reaction of extreme pain/aches/pains; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lups (lips) tingling), VACCINATION COMPLICATION (Sick with fever), PRURITUS (Itching all over), MYALGIA (severe reaction of extreme pain/aches/pains) and PYREXIA (Fever) 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 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (lups (lips) tingling), VACCINATION COMPLICATION (Sick with fever), PRURITUS (Itching all over), MYALGIA (severe reaction of extreme pain/aches/pains) and PYREXIA (Fever). At the time of the report, PARAESTHESIA ORAL (lups (lips) tingling), VACCINATION COMPLICATION (Sick with fever), PRURITUS (Itching all over), MYALGIA (severe reaction of extreme pain/aches/pains) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments    Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Abrupt onset cough; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Abrupt onset cough) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN and SILDENAFIL CITRATE (VIAGRA) for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced COUGH (Abrupt onset cough). At the time of the report, COUGH (Abrupt onset cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   This case was linked to MOD-2021-216078 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VOMITING (vomiting). At the time of the report, CHILLS (chills) and VOMITING (vomiting) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No treatment medications were reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose adminstered that was not stored properly; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (dose adminstered that was not stored properly) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (dose adminstered that was not stored properly). At the time of the report, PRODUCT STORAGE ERROR (dose adminstered that was not stored properly) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up was received on 15-JUN-2021. Reporter information was updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose is schedualed >35 after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose is schedualed >35 after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Contact information updated
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Soreness of the right arm after the first dose; Missed Second dose ( Beyond 42 days); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the right arm after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose ( Beyond 42 days)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included OLMESARTAN MEDOXOMIL for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of the right arm after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose ( Beyond 42 days)). At the time of the report, PAIN IN EXTREMITY (Soreness of the right arm after the first dose) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose ( Beyond 42 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eating disorder, Feeling abnormal, Gait disturbance
Clinical narrative: rapid heart rate; feverish; body aches; chills; could not eat drink; brain fog; shaky; breathing issues; could not walk to his truck; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues) and GAIT DISTURBANCE (could not walk to his truck) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced TACHYCARDIA (rapid heart rate). On 17-May-2021, EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, TACHYCARDIA (rapid heart rate) outcome was unknown.            No concomitant medications are  provided.  No treatment drug details was included. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia, Tachycardia, Tremor
Clinical narrative: rapid heart rate; feverish; body aches; chills; could not eat drink; brain fog; shaky; breathing issues; could not walk to his truck; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues) and GAIT DISTURBANCE (could not walk to his truck) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced TACHYCARDIA (rapid heart rate). On 17-May-2021, EATING DISORDER (could not eat drink), FEELING ABNORMAL (brain fog), TREMOR (shaky), DYSPNOEA (breathing issues), GAIT DISTURBANCE (could not walk to his truck), INSOMNIA (Could not sleep), PYREXIA (feverish), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, TACHYCARDIA (rapid heart rate) outcome was unknown.            No concomitant medications are  provided.  No treatment drug details was included. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash erythematous, Rash pruritic, Vaccination complication
Clinical narrative: Not feeling well; she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose; Really small red itchy rash marks underneath the skin; Really small red itchy rash marks underneath the skin; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Really small red itchy rash marks underneath the skin), RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin), VACCINATION COMPLICATION (Not feeling well) and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C214) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ASA for Anticoagulant therapy, SIMVASTATIN for Blood cholesterol abnormal, AMLODIPINE for Blood pressure abnormal.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced RASH PRURITIC (Really small red itchy rash marks underneath the skin) and RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin). On an unknown date, the patient experienced VACCINATION COMPLICATION (Not feeling well) and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in May 2021 for Rash pruritic and Rash erythematous, at an unspecified dose and frequency. On 30-May-2021, RASH PRURITIC (Really small red itchy rash marks underneath the skin) and RASH ERYTHEMATOUS (Really small red itchy rash marks underneath the skin) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she did not get the 2nd dose yet because it has been more than 6 weeks since she had the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 25-May-2021, the itchy rash started out from the left arm, then further 1/2 the way from the shoulder (6-7 inches down the arm), and 1/2 the way from the upper chest. The patient reported treatment with diphenhydramine (BENADRYL) cream did not help.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments     Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received on 02-07-2021 contains significant information. New events are updated.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: I am swollen; Swollen gland; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland). At the time of the report, SWELLING (I am swollen) and LYMPHADENOPATHY (Swollen gland) outcome was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Type 2 diabetes mellitus.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (tired). The patient was treated with IBUPROFEN (ADVIL ARTHRITIS PAIN) ongoing since an unknown date for Pain, at a dose of 1 dosage form; PREDNISONE ongoing since an unknown date for Pain, at a dose of 1 dosage form and HYDROXYCHLOROQUINE ongoing since an unknown date for Pain, at a dose of 1 dosage form. On 16-Jan-2021, FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient treated pain with heat & ice packs, then was put on steroid.  Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-102973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-significant follow up & added reporters address only
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose is over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose is over 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received contains non new information.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient contracted COVID-19) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (Patient contracted COVID-19). At the time of the report, COVID-19 (Patient contracted COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bursitis, COVID-19, Fatigue, Myalgia
Clinical narrative: yet to receive the second dose; Bursitis In The Arm; Sore Back; Positive COVID-19 Test; Sore Arm/ Achy; A Little Tired; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis In The Arm), BACK PAIN (Sore Back), COVID-19 (Positive COVID-19 Test), MYALGIA (Sore Arm/ Achy) and FATIGUE (A Little Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (Sore Arm/ Achy) and FATIGUE (A Little Tired). On 08-Feb-2021, the patient experienced COVID-19 (Positive COVID-19 Test). On 10-Feb-2021, the patient experienced BURSITIS (Bursitis In The Arm) and BACK PAIN (Sore Back). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (yet to receive the second dose). At the time of the report, BURSITIS (Bursitis In The Arm), BACK PAIN (Sore Back), COVID-19 (Positive COVID-19 Test), MYALGIA (Sore Arm/ Achy), FATIGUE (A Little Tired) and PRODUCT DOSE OMISSION ISSUE (yet to receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Ibuprofen every 5-6 hours to treat the initial symptoms related to the first dose
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: yet to receive the second dose; Bursitis In The Arm; Sore Back; Positive COVID-19 Test; Sore Arm/ Achy; A Little Tired; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis In The Arm), BACK PAIN (Sore Back), COVID-19 (Positive COVID-19 Test), MYALGIA (Sore Arm/ Achy) and FATIGUE (A Little Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (Sore Arm/ Achy) and FATIGUE (A Little Tired). On 08-Feb-2021, the patient experienced COVID-19 (Positive COVID-19 Test). On 10-Feb-2021, the patient experienced BURSITIS (Bursitis In The Arm) and BACK PAIN (Sore Back). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (yet to receive the second dose). At the time of the report, BURSITIS (Bursitis In The Arm), BACK PAIN (Sore Back), COVID-19 (Positive COVID-19 Test), MYALGIA (Sore Arm/ Achy), FATIGUE (A Little Tired) and PRODUCT DOSE OMISSION ISSUE (yet to receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Ibuprofen every 5-6 hours to treat the initial symptoms related to the first dose
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.) 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 treatment information was provided by the reporter. No concomitant product was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-July-2021 contains Significant information new reporter details added, updated patient details and medical history.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chills, pyrexia (fever) and myalgia (body aches) in a patient, of an unknown age and gender, 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), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had chills, pyrexia (fever) and myalgia (body aches). At the time of the report, chills, pyrexia (fever) and myalgia (body aches) outcome: unknown. Concomitant product use and treatment information not provided.