chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia, Feeling hot, SARS-CoV-2 antibody test
Clinical narrative: Since first day vaccinated, felt a rush of warmth throughout veins; Strong metallic taste in mouth; Weakness and lowenergy; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metallic taste in mouth), ASTHENIA (Weakness and lowenergy) and FEELING HOT (Since first day vaccinated, felt a rush of warmth throughout veins) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pinched nerve, Intervertebral disc bulging (Bulging disc on lower back), Chondromalacia patellae and Loss of energy. Concurrent medical conditions included Alcohol use (Occasional use of wine typically 1-2 cups of wine). Concomitant products included VITAMIN D3, CHONDROITIN SULFATE, COLLAGEN, GLUCOSAMINE (UC II), BIOTIN, VITAMIN C [ASCORBIC ACID] and VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) for an unknown indication.    On 02-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Weakness and lowenergy). On 02-Mar-2021, the patient experienced DYSGEUSIA (Strong metallic taste in mouth). On an unknown date, the patient experienced FEELING HOT (Since first day vaccinated, felt a rush of warmth throughout veins). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (Weakness and lowenergy) had not resolved and FEELING HOT (Since first day vaccinated, felt a rush of warmth throughout veins) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: >2500.0 (Inconclusive) greater than 2500.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DYSGEUSIA (Strong metallic taste in mouth) to be possibly related. No further causality assessments were provided for ASTHENIA (Weakness and lowenergy) and FEELING HOT (Since first day vaccinated, felt a rush of warmth throughout veins).    This case was linked to MOD-2021-245642 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up  received contains information regarding the patient demographics, historical conditions, concomitant medications, and additional event weakness was updated. On 02-Jul-2021: Follow-up received 26-JUL-2021. This is an amended report. Added event of felt a rush of warmth throughout veins.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: Mouth ulcers; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth ulcers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031M20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included BLOOD CELLS, PACKED HUMAN, DEXAMETHASONE ACETATE (PLAVEX), RANOLAZINE (RANEXA) and OMEPRAZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MOUTH ULCERATION (Mouth ulcers). At the time of the report, MOUTH ULCERATION (Mouth ulcers) outcome was unknown.            No treatment was provided..   This case was linked to MOD-2021-044632 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Feeling abnormal, Pharyngitis streptococcal
Clinical narrative: Diagnosed with Strep Throat; Feeling bad; Lost sense of taste; Lost sense of smell; Sluggish feeling; Tested positive for COVID19 Virus; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus), SINUSITIS (Sinus infection), FEELING ABNORMAL (Feeling bad) and AGEUSIA (Lost sense of taste) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacterial infection.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus) and SINUSITIS (Sinus infection). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell). On 27-Apr-2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Diagnosed with Strep Throat). The patient was treated with AZITHROMYCIN (Z-PAK) on 17-Apr-2021 for COVID-19 and Sinus infection, at a dose of UNK dosage form and PENICILLIN NOS for Streptococcal pharyngitis, at a dose of UNK dosage form. At the time of the report, SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus), SINUSITIS (Sinus infection), FEELING ABNORMAL (Feeling bad), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and PHARYNGITIS STREPTOCOCCAL (Diagnosed with Strep Throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  It was also reported that the patient went to receive 2nd vaccination but was turned down because of previous COVID19 diagnosis and 2 bacterial infections.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinusitis, Sluggishness
Clinical narrative: Diagnosed with Strep Throat; Feeling bad; Lost sense of taste; Lost sense of smell; Sluggish feeling; Tested positive for COVID19 Virus; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus), SINUSITIS (Sinus infection), FEELING ABNORMAL (Feeling bad) and AGEUSIA (Lost sense of taste) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bacterial infection.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus) and SINUSITIS (Sinus infection). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), AGEUSIA (Lost sense of taste) and ANOSMIA (Lost sense of smell). On 27-Apr-2021, the patient experienced PHARYNGITIS STREPTOCOCCAL (Diagnosed with Strep Throat). The patient was treated with AZITHROMYCIN (Z-PAK) on 17-Apr-2021 for COVID-19 and Sinus infection, at a dose of UNK dosage form and PENICILLIN NOS for Streptococcal pharyngitis, at a dose of UNK dosage form. At the time of the report, SLUGGISHNESS (Sluggish feeling), COVID-19 (Tested positive for COVID19 Virus), SINUSITIS (Sinus infection), FEELING ABNORMAL (Feeling bad), AGEUSIA (Lost sense of taste), ANOSMIA (Lost sense of smell) and PHARYNGITIS STREPTOCOCCAL (Diagnosed with Strep Throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  It was also reported that the patient went to receive 2nd vaccination but was turned down because of previous COVID19 diagnosis and 2 bacterial infections.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: A side effect/ Had a reaction that lasted longer than several wks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A side effect/ Had a reaction that lasted longer than several wks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A side effect/ Had a reaction that lasted longer than several wks). At the time of the report, VACCINATION COMPLICATION (A side effect/ Had a reaction that lasted longer than several wks) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non Significant Follow-up Append
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: One and a half month gone after my first Dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (One and a half month gone after my first Dose) 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (One and a half month gone after my first Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (One and a half month gone after my first Dose) 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.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old grand son received the first Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old grand son received the first Moderna vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old grand son received the first Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old grand son received the first Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional information received and Patient demographics added. On 29-Jul-2021: Follow up received and contains no new information. On 29-Jul-2021: Follow up received and contain non significant information. On 04-Aug-2021: Follow up received and contains Non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Seen several patients who also developed vertigo after receiving the vaccine; 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 VERTIGO (Seen several patients who also developed vertigo after receiving the vaccine) 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 VERTIGO (Seen several patients who also developed vertigo after receiving the vaccine). At the time of the report, VERTIGO (Seen several patients who also developed vertigo after receiving the vaccine) 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Myalgia, Vitamin D, Vitamin D deficiency
Clinical narrative: Bones were hurting him, described as everything was hurting, bone pain; Found to have no Vitamin D in his system; Left arm hurt like a bee sting; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones were hurting him, described as everything was hurting, bone pain), VITAMIN D DEFICIENCY (Found to have no Vitamin D in his system), MYALGIA (Left arm hurt like a bee sting) and FATIGUE (Tiredness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), OMEPRAZOLE and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced BONE PAIN (Bones were hurting him, described as everything was hurting, bone pain), VITAMIN D DEFICIENCY (Found to have no Vitamin D in his system) and MYALGIA (Left arm hurt like a bee sting). At the time of the report, BONE PAIN (Bones were hurting him, described as everything was hurting, bone pain), VITAMIN D DEFICIENCY (Found to have no Vitamin D in his system), MYALGIA (Left arm hurt like a bee sting) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: no vitamin-d (Low) No Vitamin-D.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nerve compression, Paraesthesia
Clinical narrative: expirienced tingling; numbness on my right side, specifically my fingers\ my arm is numb/my neck and side of my head are numb; Pinched nerves; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (expirienced tingling), HYPOAESTHESIA (numbness on my right side, specifically my fingers\ my arm is numb/my neck and side of my head are numb) and NERVE COMPRESSION (Pinched nerves) 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 PARAESTHESIA (expirienced tingling), HYPOAESTHESIA (numbness on my right side, specifically my fingers\ my arm is numb/my neck and side of my head are numb) and NERVE COMPRESSION (Pinched nerves). At the time of the report, PARAESTHESIA (expirienced tingling), HYPOAESTHESIA (numbness on my right side, specifically my fingers\ my arm is numb/my neck and side of my head are numb) and NERVE COMPRESSION (Pinched nerves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Alternative cause of the events was reported as pinched nerves in his neck.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Event and event outcome updated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Nodule, Rash erythematous, Rash pruritic
Clinical narrative: bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021; Wrists swell up; itchy red rash; Bubble like bump on the top of the wrist; itchy red rash; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Wrists swell up), RASH PRURITIC (itchy red rash), NODULE (Bubble like bump on the top of the wrist), RASH ERYTHEMATOUS (itchy red rash) and NODULE (bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced JOINT SWELLING (Wrists swell up), RASH PRURITIC (itchy red rash), NODULE (Bubble like bump on the top of the wrist) and RASH ERYTHEMATOUS (itchy red rash). On 09-Jun-2021, the patient experienced NODULE (bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Wrists swell up), RASH PRURITIC (itchy red rash), NODULE (Bubble like bump on the top of the wrist), RASH ERYTHEMATOUS (itchy red rash) and NODULE (bubble like bump on the top of the wrist which initially started on the right hand followed by the left hand next day after receiving the second dose of the vaccine on 08Jun2021) outcome was unknown.            No concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Muscle spasms, Neuralgia, Pain in extremity
Clinical narrative: piriformis muscle began to crap; pain from her hip down to her toes; squeezing on the sciatic nerve.; does not have any feeling in her toe,; nerve pain; gain some ability to walk again with the assistance of a cane; Hip Pain; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,) and NEURALGIA (nerve pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHOROTHIAZIDE), LOSARTAN, METOPROLOL, ESTRADIOL, IBUPROFEN, METFORMIN and MEDROXYPROGESTERONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (Hip Pain). On an unknown date, the patient experienced MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,), NEURALGIA (nerve pain) and WALKING AID USER (gain some ability to walk again with the assistance of a cane). The patient was treated with GABAPENTIN (NEURONTIN) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL ARTHRITIS) ongoing since an unknown date at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) ongoing since an unknown date at an unspecified dose and frequency; CYCLOBENZAPRINE (oral) ongoing since an unknown date at a dose of 10 milligram; IBUPROFEN (oral) ongoing since an unknown date at a dose of 600 milligram; PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,), NEURALGIA (nerve pain), WALKING AID USER (gain some ability to walk again with the assistance of a cane) and ARTHRALGIA (Hip Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had an MRI, the results of which were not stated.  Treatment medications also included Spinal injections and muscle relaxers.   This case was linked to MOD-2021-214904 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Sciatica, Walking aid user
Clinical narrative: piriformis muscle began to crap; pain from her hip down to her toes; squeezing on the sciatic nerve.; does not have any feeling in her toe,; nerve pain; gain some ability to walk again with the assistance of a cane; Hip Pain; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,) and NEURALGIA (nerve pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHOROTHIAZIDE), LOSARTAN, METOPROLOL, ESTRADIOL, IBUPROFEN, METFORMIN and MEDROXYPROGESTERONE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (Hip Pain). On an unknown date, the patient experienced MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,), NEURALGIA (nerve pain) and WALKING AID USER (gain some ability to walk again with the assistance of a cane). The patient was treated with GABAPENTIN (NEURONTIN) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL ARTHRITIS) ongoing since an unknown date at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) ongoing since an unknown date at an unspecified dose and frequency; CYCLOBENZAPRINE (oral) ongoing since an unknown date at a dose of 10 milligram; IBUPROFEN (oral) ongoing since an unknown date at a dose of 600 milligram; PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (piriformis muscle began to crap), PAIN IN EXTREMITY (pain from her hip down to her toes), SCIATICA (squeezing on the sciatic nerve.), HYPOAESTHESIA (does not have any feeling in her toe,), NEURALGIA (nerve pain), WALKING AID USER (gain some ability to walk again with the assistance of a cane) and ARTHRALGIA (Hip Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had an MRI, the results of which were not stated.  Treatment medications also included Spinal injections and muscle relaxers.   This case was linked to MOD-2021-214904 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site rash
Clinical narrative: Hurt the next day; Tiredness; Rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt the next day), FATIGUE (Tiredness) and VACCINATION SITE RASH (Rash around injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL, AMIODARONE, HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HCTZ) and HYDRALAZINE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PAIN (Hurt the next day), FATIGUE (Tiredness) and VACCINATION SITE RASH (Rash around injection site). On 07-May-2021, PAIN (Hurt the next day), FATIGUE (Tiredness) and VACCINATION SITE RASH (Rash around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-214886 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Malaise, Product dose omission issue
Clinical narrative: chest pain; malaise; back pain; never got the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jun-2021 and was forwarded to Moderna on 09-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (chest pain), MALAISE (malaise), BACK PAIN (back pain) and PRODUCT DOSE OMISSION ISSUE (never got the second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), MALAISE (malaise), BACK PAIN (back pain) and PRODUCT DOSE OMISSION ISSUE (never got the second dose). At the time of the report, CHEST PAIN (chest pain), MALAISE (malaise) and BACK PAIN (back pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (never got the second 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.   No concomitant medication were reported.  No treatment information was reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: soreness in arm; started feeling bad; couldn't get out bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), FEELING ABNORMAL (started feeling bad) and MOBILITY DECREASED (couldn't get out bed) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm), FEELING ABNORMAL (started feeling bad) and MOBILITY DECREASED (couldn't get out bed). The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in arm), FEELING ABNORMAL (started feeling bad) and MOBILITY DECREASED (couldn't get out bed) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No treatment medication were reported.   This case was linked to MOD-2021-044697 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES). At the time of the report, VACCINATION COMPLICATION (It sounds like you have received the Moderna COVID-19 Vaccine and have experienced a side effect. Is this correct? / YES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Swelling face
Clinical narrative: face is a little swollen; couldn't breath and was gasping for air; allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (face is a little swollen), DYSPNOEA (couldn't breath and was gasping for air) and HYPERSENSITIVITY (allergic reaction) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 016M204) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disease, unspecified. Concomitant products included OMEPRAZOLE for Oesophageal reflux, ACETYLSALICYLIC ACID (BABY ASPIRIN), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT), ALBUTEROL [SALBUTAMOL], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and PREDNISONE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 SWELLING FACE (face is a little swollen), DYSPNOEA (couldn't breath and was gasping for air) and HYPERSENSITIVITY (allergic reaction). At the time of the report, SWELLING FACE (face is a little swollen), DYSPNOEA (couldn't breath and was gasping for air) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            This case was linked to MOD-2021-214523 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of nodule (developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Previously administered products included for an unreported indication: Sculptra aesthetic on Mar 12, 2019. April 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 10, 2021, patient experienced nodule (developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected). Patient treated with Medrol Dosepak (methylprednisolone) for nodule; unknown dosage form. At the time of the report, nodule (developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected): not resolved. The reporter did not provide any causality assessments or concomitant medications. Patient received 2 doses of COVID-19 vaccine in April and May 2021. Patient developed a string of nodules to preauricular/zygoma injection areas where Sculptra was previously injected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Depression, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: began feeling hazy; difficulty breathing; light headedness; lost his appetite; Depression/ looks sad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness), DECREASED APPETITE (lost his appetite) and DEPRESSION (Depression/ looks sad) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness) and DECREASED APPETITE (lost his appetite). 27-Mar-2021, the patient experienced DEPRESSION (Depression/ looks sad). At the time of the report, FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness), DECREASED APPETITE (lost his appetite) and DEPRESSION (Depression/ looks sad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Weight: lost (Low) Lost.         Patient went to his HCP where he was given an oral anti-histamine.   Patient went to the HCP again, and was told that he might have depression.  An anti-depressive medication was started.  No concomitant medications were mentioned. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: began feeling hazy; difficulty breathing; light headedness; lost his appetite; Depression/ looks sad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness), DECREASED APPETITE (lost his appetite) and DEPRESSION (Depression/ looks sad) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness) and DECREASED APPETITE (lost his appetite). 27-Mar-2021, the patient experienced DEPRESSION (Depression/ looks sad). At the time of the report, FEELING ABNORMAL (began feeling hazy), DYSPNOEA (difficulty breathing), DIZZINESS (light headedness), DECREASED APPETITE (lost his appetite) and DEPRESSION (Depression/ looks sad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Weight: lost (Low) Lost.         Patient went to his HCP where he was given an oral anti-histamine.   Patient went to the HCP again, and was told that he might have depression.  An anti-depressive medication was started.  No concomitant medications were mentioned. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Discharge, Malaise, Myalgia
Clinical narrative: shoulder got swollen; Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters; huge blister on shoulder; not feeling well; face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing; blisters were itching; top of my shoulder hurt in the muscle; fever; shoulder hurts; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well) and RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well), RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing), RASH PRURITIC (blisters were itching), MYALGIA (top of my shoulder hurt in the muscle), PYREXIA (fever) and ARTHRALGIA (shoulder hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash vesicular, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pyrexia, at an unspecified dose and frequency. At the time of the report, SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well), RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing), RASH PRURITIC (blisters were itching), MYALGIA (top of my shoulder hurt in the muscle), PYREXIA (fever) and ARTHRALGIA (shoulder hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Reportedly, clear fluids leaked out of the viral looking blisters and they bled.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic, Rash vesicular, Swelling
Clinical narrative: shoulder got swollen; Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters; huge blister on shoulder; not feeling well; face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing; blisters were itching; top of my shoulder hurt in the muscle; fever; shoulder hurts; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well) and RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well), RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing), RASH PRURITIC (blisters were itching), MYALGIA (top of my shoulder hurt in the muscle), PYREXIA (fever) and ARTHRALGIA (shoulder hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash vesicular, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pyrexia, at an unspecified dose and frequency. At the time of the report, SWELLING (shoulder got swollen), DISCHARGE (Clear fluids started leaking out of the swelling area,Clear fluids leaked out from blisters), BLISTER (huge blister on shoulder), MALAISE (not feeling well), RASH VESICULAR (face (cheek on left side) and chest broke out with viral-looking blisters,rash-type thing), RASH PRURITIC (blisters were itching), MYALGIA (top of my shoulder hurt in the muscle), PYREXIA (fever) and ARTHRALGIA (shoulder hurts) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Reportedly, clear fluids leaked out of the viral looking blisters and they bled.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Pain; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain), HEADACHE (Headache) and PYREXIA (Fever) 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 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 PAIN (Pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (Pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications was  provided by the reporter. No concomitant medications was reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, 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 (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) 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.   No concomitant products were reported. No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to patient. More than 12 hours after vial has been punctured.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No treatment drug details was included.