chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting; Temperature of 104; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-May-2021 and was forwarded to Moderna on 30-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and PYREXIA (Temperature of 104) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No medical history was reported.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 29-May-2021, the patient experienced VOMITING (Vomiting) and PYREXIA (Temperature of 104). At the time of the report, VOMITING (Vomiting) and PYREXIA (Temperature of 104) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia, Vomiting
Clinical narrative: Muscle Cramps; Vomiting; Fever; 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 MUSCLE SPASMS (Muscle Cramps), VOMITING (Vomiting) 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 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 MUSCLE SPASMS (Muscle Cramps), VOMITING (Vomiting) and PYREXIA (Fever). At the time of the report, MUSCLE SPASMS (Muscle Cramps), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information provided. No Treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-may-2021 contains non-significant information
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Constipation, Diarrhoea, Peripheral swelling, Sleep apnoea syndrome
Clinical narrative: no strength; can't stop sneezing; went to sleep right after the shot; diarrhea; constipation; his arm turned a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his arm turned a little swollen), CONSTIPATION (constipation), ASTHENIA (no strength), DIARRHOEA (diarrhea) and SNEEZING (can't stop sneezing) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Novolin and another insulin (caller could not recollect name).    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (his arm turned a little swollen). On 13-May-2021, the patient experienced CONSTIPATION (constipation), DIARRHOEA (diarrhea) and SLEEP APNOEA SYNDROME (went to sleep right after the shot). On an unknown date, the patient experienced ASTHENIA (no strength) and SNEEZING (can't stop sneezing). On 29-May-2021, PERIPHERAL SWELLING (his arm turned a little swollen) outcome was unknown. At the time of the report, CONSTIPATION (constipation), ASTHENIA (no strength), DIARRHOEA (diarrhea), SNEEZING (can't stop sneezing) and SLEEP APNOEA SYNDROME (went to sleep right after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medication was reported .   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: no strength; can't stop sneezing; went to sleep right after the shot; diarrhea; constipation; his arm turned a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his arm turned a little swollen), CONSTIPATION (constipation), ASTHENIA (no strength), DIARRHOEA (diarrhea) and SNEEZING (can't stop sneezing) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Novolin and another insulin (caller could not recollect name).    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (his arm turned a little swollen). On 13-May-2021, the patient experienced CONSTIPATION (constipation), DIARRHOEA (diarrhea) and SLEEP APNOEA SYNDROME (went to sleep right after the shot). On an unknown date, the patient experienced ASTHENIA (no strength) and SNEEZING (can't stop sneezing). On 29-May-2021, PERIPHERAL SWELLING (his arm turned a little swollen) outcome was unknown. At the time of the report, CONSTIPATION (constipation), ASTHENIA (no strength), DIARRHOEA (diarrhea), SNEEZING (can't stop sneezing) and SLEEP APNOEA SYNDROME (went to sleep right after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medication was reported .   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Pain on the right side while breathing; 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 DYSPNOEA (Pain on the right side while breathing) 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 DYSPNOEA (Pain on the right side while breathing). At the time of the report, DYSPNOEA (Pain on the right side while breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Rash
Clinical narrative: Dermatitis; rashes on bottom of both legs after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (Dermatitis) and RASH (rashes on bottom of both legs after 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 09-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 DERMATITIS (Dermatitis) and RASH (rashes on bottom of both legs after 1st dose). At the time of the report, DERMATITIS (Dermatitis) and RASH (rashes on bottom of both legs after 1st dose) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient was given steroid cream and moisturizer to alleviate the possible adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Bleed like your on your cycle; 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 VAGINAL HAEMORRHAGE (Bleed like your on your cycle) 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 VAGINAL HAEMORRHAGE (Bleed like your on your cycle). At the time of the report, VAGINAL HAEMORRHAGE (Bleed like your on your cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Vaccination site pain
Clinical narrative: Red ring on the leg; Bruise; Slight pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red ring on the leg), CONTUSION (Bruise) and VACCINATION SITE PAIN (Slight pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Vaginal irritation. Concomitant products included CLOBETASOL for Vaginal irritation, CLONAZEPAM and ANTIBIOTICS for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 ERYTHEMA (Red ring on the leg), CONTUSION (Bruise) and VACCINATION SITE PAIN (Slight pain at the injection site). At the time of the report, ERYTHEMA (Red ring on the leg), CONTUSION (Bruise) and VACCINATION SITE PAIN (Slight pain at the injection site) outcome was unknown.            ? Treatment information was not provided.  ?    This case was linked to MOD-2021-021525 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Initial Additional-1 / NNI
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feel absolutely horrible; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel absolutely horrible) 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 MALAISE (Feel absolutely horrible). At the time of the report, MALAISE (Feel absolutely horrible) 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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Constipation, Diarrhoea, Headache, Sneezing
Clinical narrative: has headache again; went to sleep right after the shot; can't stop sneezing; has diarrhea; has had constipation for about a week; no strength; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (went to sleep right after the shot), SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea), CONSTIPATION (has had constipation for about a week) and ASTHENIA (no strength   ) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (went to sleep right after the shot), SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea) and CONSTIPATION (has had constipation for about a week). 13-May-2021, the patient experienced ASTHENIA (no strength   ) and HEADACHE (Headache). On 29-May-2021, the patient experienced HEADACHE (has headache again). The patient was treated with PARACETAMOL (TYLENOL) on 13-May-2021 for Headache, at a dose of 1 dosage form and PSEUDOEPHEDRINE on 13-May-2021 for Allergy, at a dose of 1 dosage form. On 13-May-2021, SOMNOLENCE (went to sleep right after the shot) had resolved. On 14-May-2021, HEADACHE (Headache) outcome was unknown. At the time of the report, SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea), CONSTIPATION (has had constipation for about a week), ASTHENIA (no strength   ) and HEADACHE (has headache again) outcome was unknown.            Concomitant medicine: Novolin, another insulin
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: has headache again; went to sleep right after the shot; can't stop sneezing; has diarrhea; has had constipation for about a week; no strength; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (went to sleep right after the shot), SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea), CONSTIPATION (has had constipation for about a week) and ASTHENIA (no strength   ) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced SOMNOLENCE (went to sleep right after the shot), SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea) and CONSTIPATION (has had constipation for about a week). 13-May-2021, the patient experienced ASTHENIA (no strength   ) and HEADACHE (Headache). On 29-May-2021, the patient experienced HEADACHE (has headache again). The patient was treated with PARACETAMOL (TYLENOL) on 13-May-2021 for Headache, at a dose of 1 dosage form and PSEUDOEPHEDRINE on 13-May-2021 for Allergy, at a dose of 1 dosage form. On 13-May-2021, SOMNOLENCE (went to sleep right after the shot) had resolved. On 14-May-2021, HEADACHE (Headache) outcome was unknown. At the time of the report, SNEEZING (can't stop sneezing), DIARRHOEA (has diarrhea), CONSTIPATION (has had constipation for about a week), ASTHENIA (no strength   ) and HEADACHE (has headache again) outcome was unknown.            Concomitant medicine: Novolin, another insulin
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Pain in extremity, Rash, Taste disorder
Clinical narrative: Dermatitis; Funny taste in mouth, food does not taste right; sore arm; rashes on bottom of both legs; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (Dermatitis), TASTE DISORDER (Funny taste in mouth, food does not taste right), PAIN IN EXTREMITY (sore arm) and RASH (rashes on bottom of both legs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   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 DERMATITIS (Dermatitis), TASTE DISORDER (Funny taste in mouth, food does not taste right), PAIN IN EXTREMITY (sore arm) and RASH (rashes on bottom of both legs). At the time of the report, DERMATITIS (Dermatitis), PAIN IN EXTREMITY (sore arm) and RASH (rashes on bottom of both legs) outcome was unknown and TASTE DISORDER (Funny taste in mouth, food does not taste right) had not resolved.            Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; feaver; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and PYREXIA (feaver) 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 HEADACHE (headache) and PYREXIA (feaver). At the time of the report, HEADACHE (headache) and PYREXIA (feaver) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Product administered to patient of inappropriate age
Clinical narrative: Sore arm after 1st dose; Headache after 1st dose; 13 year old received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm after 1st dose), HEADACHE (Headache after 1st dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received 1st dose) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received 1st dose). On an unknown date, the patient experienced MYALGIA (Sore arm after 1st dose) and HEADACHE (Headache after 1st dose). On 27-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received 1st dose) had resolved. At the time of the report, MYALGIA (Sore arm after 1st dose) and HEADACHE (Headache after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications provided. No treatment information provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Very high fever; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Very high fever) and ILLNESS (Very sick) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Very high fever) and ILLNESS (Very sick). At the time of the report, PYREXIA (Very high fever) and ILLNESS (Very sick) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.  Treatment medication was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-043171 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Disorientation, Headache, Muscular weakness
Clinical narrative: body keeps shaking/has been shaking/whole body shaking; limbs are weak are shaking; nerve damage in head; Very hard to cut things; trigeminal neuralgia; Has had really bad anxiety ever since this started; It continued to get worse after the second shot of the vaccine; rash on both shoulders; Pain in center of head/Pain in center of head getting worse; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (body keeps shaking/has been shaking/whole body shaking), MUSCULAR WEAKNESS (limbs are weak are shaking), NERVE INJURY (nerve damage in head), DISORIENTATION (Very hard to cut things) and TRIGEMINAL NEURALGIA (trigeminal neuralgia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information provided.  Concomitant products included GABAPENTIN, CLONIDINE, VANCOMYCIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Dec-2020, the patient experienced HEADACHE (Pain in center of head/Pain in center of head getting worse). On an unknown date, the patient experienced TREMOR (body keeps shaking/has been shaking/whole body shaking), MUSCULAR WEAKNESS (limbs are weak are shaking), NERVE INJURY (nerve damage in head), DISORIENTATION (Very hard to cut things), TRIGEMINAL NEURALGIA (trigeminal neuralgia), ANXIETY (Has had really bad anxiety ever since this started), CONDITION AGGRAVATED (It continued to get worse after the second shot of the vaccine) and RASH (rash on both shoulders). At the time of the report, TREMOR (body keeps shaking/has been shaking/whole body shaking), MUSCULAR WEAKNESS (limbs are weak are shaking), NERVE INJURY (nerve damage in head), DISORIENTATION (Very hard to cut things), TRIGEMINAL NEURALGIA (trigeminal neuralgia), ANXIETY (Has had really bad anxiety ever since this started), CONDITION AGGRAVATED (It continued to get worse after the second shot of the vaccine), RASH (rash on both shoulders) and HEADACHE (Pain in center of head/Pain in center of head getting worse) had not resolved.            Reporter stated that patient had her purse stolen and was unable to give vaccination information on lot numbers or expiration dates for both doses.After first dose patient started to get  pain in the center of her head, and pain in head had gotten worse.After second dose Pain was going down the spine.Consent to follow up with health care provider and safety.  No concomitant and treatment medications were reported.   This case was linked to MOD-2021-255329 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was updated with events details.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Rash, Tremor, Trigeminal neuralgia
Clinical narrative: body keeps shaking/has been shaking/whole body shaking; limbs are weak are shaking; nerve damage in head; Very hard to cut things; trigeminal neuralgia; Has had really bad anxiety ever since this started; It continued to get worse after the second shot of the vaccine; rash on both shoulders; Pain in center of head/Pain in center of head getting worse; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (body keeps shaking/has been shaking/whole body shaking), MUSCULAR WEAKNESS (limbs are weak are shaking), NERVE INJURY (nerve damage in head), DISORIENTATION (Very hard to cut things) and TRIGEMINAL NEURALGIA (trigeminal neuralgia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information provided.  Concomitant products included GABAPENTIN, CLONIDINE, VANCOMYCIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Dec-2020, the patient experienced HEADACHE (Pain in center of head/Pain in center of head getting worse). On an unknown date, the patient experienced TREMOR (body keeps shaking/has been shaking/whole body shaking), MUSCULAR WEAKNESS (limbs are weak are shaking), NERVE INJURY (nerve damage in head), DISORIENTATION (Very hard to cut things), TRIGEMINAL NEURALGIA (trigeminal neuralgia), ANXIETY (Has had really bad anxiety ever since this started), CONDITION AGGRAVATED (It continued to get worse after the second shot of the vaccine) and RASH (rash on both shoulders). At the time of the report, TREMOR (body keeps shaking/has been shaking/whole body shaking), MUSCULAR WEAKNESS (limbs are weak are shaking), NERVE INJURY (nerve damage in head), DISORIENTATION (Very hard to cut things), TRIGEMINAL NEURALGIA (trigeminal neuralgia), ANXIETY (Has had really bad anxiety ever since this started), CONDITION AGGRAVATED (It continued to get worse after the second shot of the vaccine), RASH (rash on both shoulders) and HEADACHE (Pain in center of head/Pain in center of head getting worse) had not resolved.            Reporter stated that patient had her purse stolen and was unable to give vaccination information on lot numbers or expiration dates for both doses.After first dose patient started to get  pain in the center of her head, and pain in head had gotten worse.After second dose Pain was going down the spine.Consent to follow up with health care provider and safety.  No concomitant and treatment medications were reported.   This case was linked to MOD-2021-255329 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was updated with events details.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: nursing mother; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (nursing mother) in a  child of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the child was diagnosed with EXPOSURE VIA BREAST MILK (nursing mother). At the time of the report, EXPOSURE VIA BREAST MILK (nursing mother) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Feel nauseated; 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 (Headache) and NAUSEA (Feel nauseated) 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 HEADACHE (Headache) and NAUSEA (Feel nauseated). At the time of the report, HEADACHE (Headache) and NAUSEA (Feel nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: feeling very sick,Soo sick and can't speak on the phone; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling very sick,Soo sick and can't speak on the phone) 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 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (feeling very sick,Soo sick and can't speak on the phone). At the time of the report, ILLNESS (feeling very sick,Soo sick and can't speak on the phone) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported. Action taken with mRNA-1273 in response to the event was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second COVID-19 dose/ Second dose more than 42 days; 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 PRODUCT DOSE OMISSION ISSUE (Missed second COVID-19 dose/ Second dose more than 42 days) 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 PRODUCT DOSE OMISSION ISSUE (Missed second COVID-19 dose/ Second dose more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second COVID-19 dose/ Second dose more than 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I missed my second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: can the first moderna shot cause nausea and diarea two weeks after the shot; can the first moderna shot cause nausea and diarea two weeks after the shot; 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 DIARRHOEA (can the first moderna shot cause nausea and diarea two weeks after the shot) and NAUSEA (can the first moderna shot cause nausea and diarea two weeks after the 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (can the first moderna shot cause nausea and diarea two weeks after the shot) and NAUSEA (can the first moderna shot cause nausea and diarea two weeks after the shot). At the time of the report, DIARRHOEA (can the first moderna shot cause nausea and diarea two weeks after the shot) and NAUSEA (can the first moderna shot cause nausea and diarea two weeks after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red circular bump from injection; 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 SWELLING (red circular bump from injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (red circular bump from injection). At the time of the report, VACCINATION SITE SWELLING (red circular bump from injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: cough; stuffy nose; headache; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), HEADACHE (headache), MYALGIA (body ache) 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 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 COUGH (cough), NASAL CONGESTION (stuffy nose), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever). At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), HEADACHE (headache), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.            Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: side effects after a month later of having their second shot; rash on my right arm; Baseball size Red rash at injection site; hot to touch; It was hard at injection site; It was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects after a month later of having their second shot), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site), VACCINATION SITE PAIN (It was sore at injection site) and VACCINATION SITE RASH (rash on my right arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bile acid malabsorption since 2018, Idiopathic hypersomnia since 2018, Hyperlipidemia, Cholesterol high since 2010, Drug allergy (Allergy to Prednisolone (anxiety)), Allergy to antibiotic (Allergy to Vancomycin(Redman syndrome)), Drug allergy (Allergy  to codeine (headache, confusion)) and Allergy to antibiotic (Allergy to levofloxacin (rash)). Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for Bile acid malabsorption, ATORVASTATIN for Hyperlipidemia, MODAFINIL for an unknown indication.   On 27-Apr-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021 at 2:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site) and VACCINATION SITE PAIN (It was sore at injection site). On 28-Apr-2021, the patient experienced VACCINATION SITE RASH (rash on my right arm) and VACCINATION SITE ERYTHEMA (Baseball size Red rash at injection site). On an unknown date, the patient experienced ADVERSE REACTION (side effects after a month later of having their second shot). On 01-May-2021, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site), VACCINATION SITE PAIN (It was sore at injection site), VACCINATION SITE RASH (rash on my right arm) and VACCINATION SITE ERYTHEMA (Baseball size Red rash at injection site) had resolved. At the time of the report, ADVERSE REACTION (side effects after a month later of having their second shot) had resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received contains no new information On 27-Jul-2021: Follow up amendment : Start date, stop date and event outcome added which were provided in last FU.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: side effects after a month later of having their second shot; rash on my right arm; Baseball size Red rash at injection site; hot to touch; It was hard at injection site; It was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effects after a month later of having their second shot), VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site), VACCINATION SITE PAIN (It was sore at injection site) and VACCINATION SITE RASH (rash on my right arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bile acid malabsorption since 2018, Idiopathic hypersomnia since 2018, Hyperlipidemia, Cholesterol high since 2010, Drug allergy (Allergy to Prednisolone (anxiety)), Allergy to antibiotic (Allergy to Vancomycin(Redman syndrome)), Drug allergy (Allergy  to codeine (headache, confusion)) and Allergy to antibiotic (Allergy to levofloxacin (rash)). Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for Bile acid malabsorption, ATORVASTATIN for Hyperlipidemia, MODAFINIL for an unknown indication.   On 27-Apr-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021 at 2:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site) and VACCINATION SITE PAIN (It was sore at injection site). On 28-Apr-2021, the patient experienced VACCINATION SITE RASH (rash on my right arm) and VACCINATION SITE ERYTHEMA (Baseball size Red rash at injection site). On an unknown date, the patient experienced ADVERSE REACTION (side effects after a month later of having their second shot). On 01-May-2021, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE INDURATION (It was hard at injection site), VACCINATION SITE PAIN (It was sore at injection site), VACCINATION SITE RASH (rash on my right arm) and VACCINATION SITE ERYTHEMA (Baseball size Red rash at injection site) had resolved. At the time of the report, ADVERSE REACTION (side effects after a month later of having their second shot) had resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received contains no new information On 27-Jul-2021: Follow up amendment : Start date, stop date and event outcome added which were provided in last FU.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Ongoing severe side effects from first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION COMPLICATION (Ongoing severe side effects from first 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 provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Ongoing severe side effects from first vaccine). At the time of the report, VACCINATION COMPLICATION (Ongoing severe side effects from first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; 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 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 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm is sore; 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 MYALGIA (arm is sore) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm is sore). At the time of the report, MYALGIA (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  No treatment medication provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: threw up; body aches; chills; high temp; 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 VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache). At the time of the report, VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Body temperature: 100.2 (High) now 100.2. On an unknown date, Body temperature: 103 (High) high temperature up to 103.         No concomitant medication was reported. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: threw up; body aches; chills; high temp; 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 VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache). At the time of the report, VOMITING (threw up), MYALGIA (body aches), CHILLS (chills), PYREXIA (high temp) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Body temperature: 100.2 (High) now 100.2. On an unknown date, Body temperature: 103 (High) high temperature up to 103.         No concomitant medication was reported. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Drug specific antibody absent
Clinical narrative: Antibodies were extremely low; This spontaneous case was reported by a consumer and describes the occurrence of DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Psoriatic arthritis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (unknown route) 11 milligram. On an unknown date, the patient experienced DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low). At the time of the report, DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Antibodies were extremely low.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  Treatment medications were unknown.  The patient received Xeljanx XR 11mg for psoriatic arthritis and the patient was immunocompromised. The patient had Moderna Covid vaccine on 05-MAR-2021 and 11-APR-2021 and recently had an antibody test and her antibodies were extremely low. The patient's doctor thinks the patient should get the Pfizer covid vaccine but wanted her to be off the Xeljanz before the patient takes it and wait two weeks before the patient starts it again.   This case was linked to MOD-2021-187597 (Patient Link).