chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Palpitations, Pyrexia, Sinus congestion
Clinical narrative: TIRED; FLARE OF CONGESTION, SINUS, RED EYES; FEVER; RED EYES; CONGESTION IN HEAD AND EARS/ SINUS ISSUES; CHEST PAIN/TWINGE OF PAIN IN UPPER CHEST; RACING HEART; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: no thyriod gland, and concurrent conditions included: high cholesterol, non alcoholic, non smoker, trees allergy, grass allergy, ragweed allergy, pollen allergy, and latex allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine dihydrochloride for allergy, montelukast sodium for allergy, rosuvastatin calcium for high cholesterol, and levothyroxine sodium for thyroidectomy. On MAR-2021, the patient experienced red eyes. On MAR-2021, the patient experienced congestion in head and ears/ sinus issues. On MAR-2021, the patient experienced chest pain/twinge of pain in upper chest. On MAR-2021, the patient experienced racing heart. Laboratory data included: Blood test (NR: not provided) no significant findings, and Laboratory test (NR: not provided) no significant findings. On 05-MAR-2021, the patient experienced fever. On AUG-2021, the patient experienced flare of congestion, sinus, red eyes. On an unspecified date, the patient experienced tired. Treatment medications (dates unspecified) included: paracetamol, methylprednisolone, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red eyes, and congestion in head and ears/ sinus issues on JUN-2021, chest pain/twinge of pain in upper chest, flare of congestion, sinus, red eyes on OCT-2021, and fever on 09-MAR-2021, and the outcome of tired and racing heart was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Musculoskeletal stiffness, Myalgia, Pain, Unevaluable event
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and gender. The patient's concomitant medications, height and weight not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number not reported) dose, start therapy date not reported for immunization. The patient never had the flu, never got a cold. The batch/lot number not reported. The company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced stiff muscles 24/7, pain all the time, felt a difference in their body, constantly cold, and muscles always sore. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from muscles always sore, stiff muscles 24/7, pain all the time, and constantly cold. The outcome of felt a difference in their body not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: FLU-LIKE SYMPTOMS; FEELING SICK; FATIGUE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol drinker, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (anaphylactic reaction) when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient experienced flu-like symptoms. On 12-MAR-2021, the patient experienced feeling sick. On 12-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, feeling sick, and fatigue on 15-MAR-2021. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Illness
Clinical narrative: HAVING ELEVATED HEART RATE (100 BEATS PER MINUTE AND UP TO 138 BEATS PER MINUTE WHILE RESTING); TROUBLE BREATHING; SICK TO WORK MID DAY; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced having elevated heart rate (100 beats per minute and up to 138 beats per minute while resting). On 26-OCT-2021, the patient experienced trouble breathing. On 26-OCT-2021, the patient experienced sick to work mid day. Laboratory data included: Heart rate (NR: not provided) 100 beats per minute (elevated), 138 beats per minute while resting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from having elevated heart rate (100 beats per minute and up to 138 beats per minute while resting), and trouble breathing, and the outcome of sick to work mid day was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: MILD BUT PERSISTENT HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced mild but persistent headache, and low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild but persistent headache, and low-grade fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: RECEIVED A MODERNA BOOSTER SHOT; CHILLS; FATIGUE; PAIN AT INJECTION SITE; ARM MUSCLE PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had covid-19 three times (uncertain regarding if before or after vaccine). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination.  On an unspecified date, the patient experienced received a moderna booster shot, chills, fatigue, pain at injection site, arm muscle pain, diarrhea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, pain at injection site, arm muscle pain, chills, diarrhea, headache and received a moderna booster shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination error
Clinical narrative: RECEIVED A MODERNA BOOSTER SHOT; CHILLS; FATIGUE; PAIN AT INJECTION SITE; ARM MUSCLE PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had covid-19 three times (uncertain regarding if before or after vaccine). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination.  On an unspecified date, the patient experienced received a moderna booster shot, chills, fatigue, pain at injection site, arm muscle pain, diarrhea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, pain at injection site, arm muscle pain, chills, diarrhea, headache and received a moderna booster shot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced polymyalgia rheumatica (pmr) when treated with varicella zoster vaccine live (oka/merck) for shingles. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Muscle strain, Pain
Clinical narrative: FELT ACHEY; INTERMITTENT SHARP PAINS IN CHEST; DULL AND HEAVY FEELING IN CHEST; PULLED A MUSCLE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 23-OCT-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced felt achey. On OCT-2021, the patient experienced intermittent sharp pains in chest. On OCT-2021, the patient experienced dull and heavy feeling in chest. On OCT-2021, the patient experienced pulled a muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt achey, intermittent sharp pains in chest, and dull and heavy feeling in chest, and the outcome of pulled a muscle was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: ADMINISTERED TWO DOSES OF VACCINE (FIRST DOSE ON MAR-2021 AND SECOND TWO DOSE ON 04-SEP-2021); OFF LABEL USE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021, and dose was not reported, administered on 04-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-SEP-2021, the patient experienced administered two doses of vaccine (first dose on mar-2021 and second two dose on 04-sep-2021). On 04-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and administered two doses of vaccine (first dose on mar-2021 and second two dose on 04-sep-2021) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: HAD BEEN INJURED BY VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had been injured by vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had been injured by vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052831 and 20211051962.
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: HAD BEEN INJURED BY VACCINE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had been injured by vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had been injured by vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211051962 and 20211052814.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blepharospasm, Dizziness, Feeling abnormal, Pain in extremity
Clinical narrative: twitching in the eye; tingling in the feet, legs and left side of face; Swelling on the left side of the face; Pain in feet and legs; felt like was going to fall; dizziness; off balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Improvement) since 01-Jan-1993, Allergy to animals (Allergy to cats), Pollen allergy, Dust allergy and Food allergy (Allergy to Shrimp). Concomitant products included LOSARTAN from 01-Jan-2013 to an unknown date, TRIAMTERENE from 01-Jan-1993 to an unknown date, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) from 01-Jan-2020 to an unknown date and VITAMIN D3 from 01-Jan-2020 to an unknown date for an unknown indication.    On 16-Aug-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021 at 10:45 AM, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall). On 08-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in feet and legs). On 11-Oct-2021, the patient experienced PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face). On 11-Oct-2021 at 5:30 AM, the patient experienced BLEPHAROSPASM (twitching in the eye). On 17-Aug-2021, DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall) had resolved. At the time of the report, BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) had not resolved and PAIN IN EXTREMITY (Pain in feet and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face), SWELLING FACE (Swelling on the left side of the face) and PAIN IN EXTREMITY (Pain in feet and legs) to be possibly related. No further causality assessment was provided for FEELING ABNORMAL (felt like was going to fall).    Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received, contains patient demographics, event swelling in face and pain in leg, medical history and concomitant medications added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: twitching in the eye; tingling in the feet, legs and left side of face; Swelling on the left side of the face; Pain in feet and legs; felt like was going to fall; dizziness; off balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Improvement) since 01-Jan-1993, Allergy to animals (Allergy to cats), Pollen allergy, Dust allergy and Food allergy (Allergy to Shrimp). Concomitant products included LOSARTAN from 01-Jan-2013 to an unknown date, TRIAMTERENE from 01-Jan-1993 to an unknown date, LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) from 01-Jan-2020 to an unknown date and VITAMIN D3 from 01-Jan-2020 to an unknown date for an unknown indication.    On 16-Aug-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021 at 10:45 AM, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall). On 08-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in feet and legs). On 11-Oct-2021, the patient experienced PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face). On 11-Oct-2021 at 5:30 AM, the patient experienced BLEPHAROSPASM (twitching in the eye). On 17-Aug-2021, DIZZINESS (dizziness), BALANCE DISORDER (off balance) and FEELING ABNORMAL (felt like was going to fall) had resolved. At the time of the report, BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face) and SWELLING FACE (Swelling on the left side of the face) had not resolved and PAIN IN EXTREMITY (Pain in feet and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (dizziness), BALANCE DISORDER (off balance), BLEPHAROSPASM (twitching in the eye), PARAESTHESIA (tingling in the feet, legs and left side of face), SWELLING FACE (Swelling on the left side of the face) and PAIN IN EXTREMITY (Pain in feet and legs) to be possibly related. No further causality assessment was provided for FEELING ABNORMAL (felt like was going to fall).    Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received, contains patient demographics, event swelling in face and pain in leg, medical history and concomitant medications added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021.    On 15-Oct-2021 at 8:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  No treatment medication reported by reporter.  The vial did not undergo any temperature excursions.   This case was linked to MOD-2021-354542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant Follow up- Medical history updated
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Biopsy, Diffuse alopecia
Clinical narrative: Patient has been losing at least the 60% hair in the past 6 months.  She was diagnosed by biopsy with "telogenic efluvian"; Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now; This spontaneous case was reported by a nurse and describes the occurrence of ALOPECIA (Patient has been losing at least the 60% hair in the past 6 months.  She was diagnosed by biopsy with "telogenic efluvian") and DIFFUSE ALOPECIA (Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 037D21A) for COVID-19 vaccination.     The patient's past medical history included Telogen effluvium.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-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 ALOPECIA (Patient has been losing at least the 60% hair in the past 6 months.  She was diagnosed by biopsy with "telogenic efluvian") and DIFFUSE ALOPECIA (Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now). At the time of the report, ALOPECIA (Patient has been losing at least the 60% hair in the past 6 months.  She was diagnosed by biopsy with "telogenic efluvian") and DIFFUSE ALOPECIA (Diagnosed by biopsy with telogenic efluvian, same in the past after a surgery, but not so intense like now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: telogen effluvium (abnormal) She was diagnosed by biopsy with telogen effluvium.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Reporter address and patient age updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash in the injection site; itch in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site). At the time of the report, VACCINATION SITE RASH (Rash in the injection site) and VACCINATION SITE PRURITUS (itch in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated 1st dose on 9-17-21 .Some itch and rash in the injection site. It last for 48hs then goes away by itself.  No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-355778 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: follow up document received on 20-Oct-2021 contains Non significant Follow up information.; Reporter's Comments: Per SO, please obtain email address for SO follow up Agent made outbound call 20Oct2021 at 2:19 PM ET and spoke to patient who states she never gave follow up consent for Safety initially although consent was granted as per original case and does not want to be followed up with regarding original adverse event case.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Rash in the injection site; itch in the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash in the injection site) and PRURITUS (itch in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site) and PRURITUS (itch in the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in October 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash in the injection site) had not resolved and PRURITUS (itch in the injection site) outcome was unknown.            No concomitant medications were reported. Patient reports that she's experiencing Rash at the time of the report, i.e.,18-Oct-2021 and its not resolved. She took Benadryl and it helped her with the symptoms.   This case was linked to MOD-2021-355776 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received contains non-significant information.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Exposure via breast milk
Clinical narrative: Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea; Vaccine exposure via breastmilk; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, ABNORMAL FAECES (Baby who was breastfed, stool is more than normal, it is not like a solid but also not like diarrhea) outcome was unknown and EXPOSURE VIA BREAST MILK (Vaccine exposure via breastmilk) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  CC: This case concerns a male patient, unknown age, with breastfeeding mother who had maternal exposure during breastfeeding and no other medical history, who experienced the non-serious, unexpected events of exposure via breastmilk and abnormal faeces. The events occurred  on unknown day after mother received unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-356031 (Parent-Child Link).   See case MOD-2021-356031 for details regarding the Parent case.; Sender's Comments: This case concerns a male patient, unknown age, with breastfeeding mother who had maternal exposure during breastfeeding and no other medical history, who experienced the non-serious, unexpected events of exposure via breastmilk and abnormal faeces. The events occurred  on unknown day after mother received unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 4 patients past 30 days in refrigerator.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 4 patients past 30 days in refrigerator.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 4 patients past 30 days in refrigerator.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to 4 patients past 30 days in refrigerator.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-355911, MOD-2021-355908 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up received on 21-Oct-2021 contains non significant information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials. 16 patients received 0.25 ml booster dose. 3 patients received 0.5 ml full dose. Event onset time was given 01:18pm Vaccination facility information is reported as Doctors office, and the address is 4360 Chamblee-Dunwoody Rd, Suite 370 with clinical name Arbor / Haven OBGYN.   This case was linked to US-MODERNATX, INC.-MOD-2021-362642, US-MODERNATX, INC.-MOD-2021-362750 (E2B Linked Report). This case was linked to MOD-2021-362017, MOD-2021-362031, MOD-2021-361987, MOD-2021-362064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received on 18-oct-2021 and contains NNI. On 24-Oct-2021: Patient initials ,narrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-362750:cluster master file MOD-2021-355973 US-MODERNATX, INC.-MOD-2021-362642:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Burning sensation, Feeling abnormal, Pain in extremity
Clinical narrative: Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine; started having temperature; pain under the arm pit; burning under the arm pit like if it was administered there/burning; appeared like a ball; pain in my legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine) and PYREXIA (started having temperature) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit). On an unknown date, the patient experienced FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 Tylenol. At the time of the report, BURNING SENSATION (burning under the arm pit like if it was administered there/burning) had not resolved and SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2021, Body temperature: high (High) probably 100°F or 101°F (couldn't check it).         Concomitant medication of the patient was not reported.  After the first dose, the patient did not experience any adverse events.  The patient received the second dose at 6 o clock. The burning started between Saturday and Sunday and started to get worried. On 18-Oct-2021, the patient went to urgent care where it was told it was a side effect to the Moderna Vaccine and on Friday the patient had an ultrasound.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine; started having temperature; pain under the arm pit; burning under the arm pit like if it was administered there/burning; appeared like a ball; pain in my legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine) and PYREXIA (started having temperature) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, the patient experienced BURNING SENSATION (burning under the arm pit like if it was administered there/burning), SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit). On an unknown date, the patient experienced FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 Tylenol. At the time of the report, BURNING SENSATION (burning under the arm pit like if it was administered there/burning) had not resolved and SWELLING (appeared like a ball), PAIN IN EXTREMITY (pain in my legs), FEELING ABNORMAL (Now it bothers me, like if there is something inflamed, when it has the arm hanging a lot of time, like if there is something there that it's not mine), PYREXIA (started having temperature) and AXILLARY PAIN (pain under the arm pit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2021, Body temperature: high (High) probably 100°F or 101°F (couldn't check it).         Concomitant medication of the patient was not reported.  After the first dose, the patient did not experience any adverse events.  The patient received the second dose at 6 o clock. The burning started between Saturday and Sunday and started to get worried. On 18-Oct-2021, the patient went to urgent care where it was told it was a side effect to the Moderna Vaccine and on Friday the patient had an ultrasound.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pollakiuria, Product dose omission issue, Pruritus
Clinical narrative: Numbness; Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain; keep going to the bathroom, urinating; Extreme itching under arms and all the crevice areas on body; >than 35 days since first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain), POLLAKIURIA (keep going to the bathroom, urinating), PRURITUS (Extreme itching under arms and all the crevice areas on body) and PRODUCT DOSE OMISSION ISSUE (>than 35 days since first dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain), POLLAKIURIA (keep going to the bathroom, urinating), PRURITUS (Extreme itching under arms and all the crevice areas on body) and PRODUCT DOSE OMISSION ISSUE (>than 35 days since first dose). At the time of the report, HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling in hand, feet, and legs and arms./like little pins and needs like nerve problems/needle pain) had not resolved, POLLAKIURIA (keep going to the bathroom, urinating) outcome was unknown and PRURITUS (Extreme itching under arms and all the crevice areas on body) and PRODUCT DOSE OMISSION ISSUE (>than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Laboratory information included test for sugar and the results were normal.  Patient states that she was doing research to find out whether she was having Guillen-Barre disease.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided by reporter. No treatment medication provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides, Blood triglycerides increased, Gamma-glutamyltransferase, Gamma-glutamyltransferase increased, Low density lipoprotein
Clinical narrative: GGT is off the charts,GGT is 460; triglycerides was also high, about 150; L-LDL was also a little high; This spontaneous case was reported by a consumer and describes the occurrence of GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-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 GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high). At the time of the report, GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood triglycerides: about 150 (High) about 150 (unspecified units). On an unknown date, Gamma-glutamyltransferase: 460 (High) 460 (unspecified units). On an unknown date, Low density lipoprotein: little high (High) little high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Low density lipoprotein increased
Clinical narrative: GGT is off the charts,GGT is 460; triglycerides was also high, about 150; L-LDL was also a little high; This spontaneous case was reported by a consumer and describes the occurrence of GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-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 GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high). At the time of the report, GAMMA-GLUTAMYLTRANSFERASE INCREASED (GGT is off the charts,GGT is 460), BLOOD TRIGLYCERIDES INCREASED (triglycerides was also high, about 150) and LOW DENSITY LIPOPROTEIN INCREASED (L-LDL was also a little high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood triglycerides: about 150 (High) about 150 (unspecified units). On an unknown date, Gamma-glutamyltransferase: 460 (High) 460 (unspecified units). On an unknown date, Low density lipoprotein: little high (High) little high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.