chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Illness
Clinical narrative: MADE ME SICK; CONDITION AGGRAVATED; FELT WORSE; This spontaneous report received from a patient concerned. The patient's past medical history included covid. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 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 number. No concomitant medications were reported. On an unspecified date, the patient experienced made me sick, condition aggravated, and felt worse. The action taken with covid-19 vaccine was not applicable. The outcome of the made me sick, condition aggravated, and felt worse was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: ARM ACHE; SLIGHT FEVER; TIREDNESS; This spontaneous report received from a patient via a representative. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) 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 arm ache, slight fever, and tiredness. The action taken with covid-19 vaccine was not applicable. The outcome of the arm ache, slight fever, and tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: COULDN'T WALK; 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, and batch number were not reported) 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 couldn't walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of couldn't walk was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: BALL UNDER ARMPIT; This spontaneous report received from a parent via a company representative concerned a female 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, and batch number were not reported) 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 ball under armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ball under armpit. This report was non-serious. This case, from the same reporter is linked to 20211260992.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral
Clinical narrative: LOST SIGHT IN RIGHT EYE; This spontaneous report received from a consumer through a company representative concerned a female of unspecified age, race and ethnicity. 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 (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that the patient (wife of reporter) "lost sight in her right eye 4 days after vaccination" (dose number in series: 1) and had to have surgery on both eyes. Per reporter the patient "would probably never totally regain vision, So currently advancing vision care". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost sight in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211260908-COVID-19 VACCINE AD26.COV2.S-Lost sight in right eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID TWICE; 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, and batch number were not reported) 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 covid twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid twice was not reported. This report was non-serious. The report was associated with product quality complaint number: 90000209172.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: BALL UNDER ARMPIT; This spontaneous report received from a consumer concerned a female 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, intramuscular, batch number was not reported) 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 ball under armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ball under armpit was not reported. This report was non-serious. This case, from the same reporter is linked to 20211260849.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS AFTER EXPIRATION DATE; This spontaneous report received from a health care professional concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced vaccine was administered 2 days after expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered 2 days after expiration date was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Rash macular, Skin disorder
Clinical narrative: SPOTS ON BACK HIPS BUTTOCKS AND SLIGHTLY DOWN THE BACK OF THIGHS; SEVERAL RED BLOTCHES SCATTER ON BACK; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: influenza vaccine ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from OCT-2021 for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced spots on back hips buttocks and slightly down the back of thighs, and several red blotches scatter on back. Treatment medications (dates unspecified) included: cortisone, and montelukast sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with influenza vaccine was not reported. The patient had not recovered from several red blotches scatter on back, and the outcome of spots on back hips buttocks and slightly down the back of thighs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE (LASTED ABOUT 2 MONTHS); This spontaneous report received from a patient concerned a 71 year old of unspecified 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, and batch number were not reported) dose, start therapy date were not reported 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 headache (lasted about 2 months). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache (lasted about 2 months). This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: PERSISTENT HEADACHE IN THE REAR PART OF HEAD; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 185 pounds, and height was 73 inches. The patient's concurrent conditions included: no alcohol user, smoker, and sulfur allergy, and other pre-existing medical conditions included: Patient never had headache before and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, expiry: unknown) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced persistent headache in the rear part of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache in the rear part of head. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED 13 HOURS AFTER INITIAL PUNCTURE; INCORRECTLY STORED VACCINE ADMINISTRATED; This spontaneous report received from a health care professional 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, and batch number: 211D21A expiry: 11-APR-2022) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-DEC-2021, the patient experienced vaccine administered 13 hours after initial puncture, and incorrectly stored vaccine administrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered 13 hours after initial puncture and incorrectly stored vaccine administrated was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a parent concerned a 33 year old female. 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hives. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: ARM ACHE; SLIGHT FEVER; TIREDNESS; This spontaneous report received from a consumer 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, and batch number were not reported) 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 arm ache, slight fever, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm ache, slight fever and tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20211260580.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: FIGHTING COVID; This spontaneous report received from a patient via a company representative concerned a 60 year old of unspecified 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, and batch number were not reported) dose was not reported, administered on JUN-2021 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 fighting covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fighting covid. This report was non-serious. This report was associated with product quality complaint: 90000209189.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: SHOULDER PAIN FROM PREVIOUS INJURY WAS COMPLETELY HEALED/UNEXPECTED THERAPEUTIC BENEFIT; PAIN UPON INJECTION; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: shoulder injury in the right arm, and concurrent conditions included: shoulder pain from the previous injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced pain upon injection. On 30-APR-2021, the patient experienced shoulder pain from previous injury was completely healed/unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain upon injection on 30-APR-2021, and the outcome of shoulder pain from previous injury was completely healed/unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
Clinical narrative: HEAVY MENSTRUATION; DELAYED MENSTRUATION; IRREGULAR MENSTRUATION; This spontaneous report received from a consumer concerned multiple patients. The batch number was not reported and has been requested. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 heavy menstruation, delayed menstruation, and irregular menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heavy menstruation, delayed menstruation and irregular menstruation was not reported. This report was non-serious. This case, from the same reporter is linked to 20211261052.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18yrs of age was given a booster dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18yrs of age was given a booster dose of Moderna) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18yrs of age was given a booster dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18yrs of age was given a booster dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: itchy; arm hurt and wasn't bad.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and PAIN (arm hurt and wasn't bad.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRURITUS (itchy) and PAIN (arm hurt and wasn't bad.). At the time of the report, PRURITUS (itchy) and PAIN (arm hurt and wasn't bad.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-402924 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 045B21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 13-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.). On 13-Nov-2021, ACCIDENTAL UNDERDOSE (We now think that she was more appropriate for the 3rd primary series vaccine, and not the booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient was taking oral cancer medications.  The reporter stated that the patient had received 2 primary vaccine doses and a booster dose of the Moderna Covid-19 vaccine. The patient had indicated that they were a cancer patient and was taking oral cancer medications. Reportedly, the patient had come in asking for a 3rd dose and received a 0.25mL booster. The reporter now think that the patient was more appropriate for the 3rd primary series vaccine, and not the booster. The patient had not reported any known symptoms.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Pneumonia
Clinical narrative: pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.   On 27-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 PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: 4.         Concomitant medications were not reported. Treatment medications were not reported.  Reporter stated that patient is prone to bronchitis and pneumonia as she is a smoker.  Company Comment  This case concerns a female patient of an unknown age with a reported medical history of smoking, who experienced the serious unexpected event of Pneumonia. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The medical history of smoking is a confounder. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up received as patient demographics, lab data, medical history, dose details updated.; Sender's Comments: This case concerns a female patient of an unknown age with a reported medical history of smoking, who experienced the serious unexpected event of Pneumonia. The event occurred on an unspecified date after the second dose of mRNA-1273 vaccine. The medical history of smoking is a confounder. The benefit-risk relationship of mRNA -1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: minor headache/neck pain; dizziness; minor headache/neck pain; mnor fatigue; lymp nodes under left arm swelled and became painful; sick for 7 days /in bed for 4 days; 101°F fever; large muscle pain; joint pain; lymph nodes under the left arm swelled till the ribs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever) and MYALGIA (large muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Undifferentiated connective tissue disease (undifferentiated Connective tissue Disorder likely as a result of chronic Lyme) in 1991. Concurrent medical conditions included Penicillin allergy and Lactose intolerance.   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 10-Apr-2021, the patient experienced ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs). On an unknown date, the patient experienced NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) in April 2021 for No adverse event, at a dose of 500 mg and PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at a dose of every 4 hours for 3 days. At the time of the report, ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain), VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101°F fever..         Concomitant information was not reported.   This case was linked to MOD-2021-404059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow up received and it contains information about demographics and patient historical condition and allergies and events were added outcome updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lymph node pain, Myalgia, Neck pain, Pyrexia
Clinical narrative: minor headache/neck pain; dizziness; minor headache/neck pain; mnor fatigue; lymp nodes under left arm swelled and became painful; sick for 7 days /in bed for 4 days; 101°F fever; large muscle pain; joint pain; lymph nodes under the left arm swelled till the ribs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever) and MYALGIA (large muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Undifferentiated connective tissue disease (undifferentiated Connective tissue Disorder likely as a result of chronic Lyme) in 1991. Concurrent medical conditions included Penicillin allergy and Lactose intolerance.   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 10-Apr-2021, the patient experienced ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs). On an unknown date, the patient experienced NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) in April 2021 for No adverse event, at a dose of 500 mg and PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at a dose of every 4 hours for 3 days. At the time of the report, ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain), VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101°F fever..         Concomitant information was not reported.   This case was linked to MOD-2021-404059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow up received and it contains information about demographics and patient historical condition and allergies and events were added outcome updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: minor headache/neck pain; dizziness; minor headache/neck pain; mnor fatigue; lymp nodes under left arm swelled and became painful; sick for 7 days /in bed for 4 days; 101°F fever; large muscle pain; joint pain; lymph nodes under the left arm swelled till the ribs; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever) and MYALGIA (large muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Undifferentiated connective tissue disease (undifferentiated Connective tissue Disorder likely as a result of chronic Lyme) in 1991. Concurrent medical conditions included Penicillin allergy and Lactose intolerance.   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 10-Apr-2021, the patient experienced ILLNESS (sick for 7 days /in bed for 4 days), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs). On an unknown date, the patient experienced NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) in April 2021 for No adverse event, at a dose of 500 mg and PARACETAMOL (TYLENOL [PARACETAMOL]) for No adverse event, at a dose of every 4 hours for 3 days. At the time of the report, ILLNESS (sick for 7 days /in bed for 4 days), NECK PAIN (minor headache/neck pain), DIZZINESS (dizziness), PYREXIA (101°F fever), MYALGIA (large muscle pain), ARTHRALGIA (joint pain), VACCINATION SITE LYMPHADENOPATHY (lymph nodes under the left arm swelled till the ribs), HEADACHE (minor headache/neck pain), FATIGUE (mnor fatigue) and LYMPH NODE PAIN (: lymp nodes under left arm swelled and became painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (High) 101°F fever..         Concomitant information was not reported.   This case was linked to MOD-2021-404059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow up received and it contains information about demographics and patient historical condition and allergies and events were added outcome updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Six patients received expired Moderna vaccine booster shots after 30-day Use by Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use by Date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use by Date). On 27-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Six patients received expired Moderna vaccine booster shots after 30-day Use by Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received expired Moderna vaccine booster shot on 27-Dec-2021 after 30 day use by date after manufacturer date of expiry. The vaccine's expiration date was 23-Dec-2021. The date the vial was initially stored in the refrigerator was unknown. Reportedly, the vial didn't undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2021-429306 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral swelling, Quantitative sudomotor axon reflex test, Small fibre neuropathy
Clinical narrative: Significant small fiber neuropathy  in legs and in arms; she is currently experiencing ongoing numbness in both feet; Pins and needles both feet; Both feet swelled; Numbness in feet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (she is currently experiencing ongoing numbness in both feet), PARAESTHESIA (Pins and needles both feet), PERIPHERAL SWELLING (Both feet swelled), SMALL FIBRE NEUROPATHY (Significant small fiber neuropathy  in legs and in arms) and HYPOAESTHESIA (Numbness in feet) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Headache.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (Both feet swelled) and HYPOAESTHESIA (Numbness in feet). On 01-Dec-2021, the patient experienced HYPOAESTHESIA (she is currently experiencing ongoing numbness in both feet) and PARAESTHESIA (Pins and needles both feet). On an unknown date, the patient experienced SMALL FIBRE NEUROPATHY (Significant small fiber neuropathy  in legs and in arms). At the time of the report, HYPOAESTHESIA (she is currently experiencing ongoing numbness in both feet) and PARAESTHESIA (Pins and needles both feet) had not resolved and PERIPHERAL SWELLING (Both feet swelled), SMALL FIBRE NEUROPATHY (Significant small fiber neuropathy  in legs and in arms) and HYPOAESTHESIA (Numbness in feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Quantitative sudomotor axon reflex test: positive (Positive) Positive for Significant small fiber neuropathy.     Concomitant medication includes: Headache medicines Treatment medication includes: Steroids Lab data includes: X-Rays, and other series of tests were performed after one month of second dose vaccination, results were not reported.  Symptoms: It was reported that the patient had performed QSART test which came back positive as Significant small fiber neuropathy in legs and arms but patient reported that she had no symptoms in her arms yet, she had schedule a biopsy for 10-Dec-2021. patient had no known drug and food allergy.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient All booster doses were injected intramuscularly in deltoid muscle. No treatment information were reported. No concomitant medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Freezing phenomenon
Clinical narrative: felt like he was freezing; sweating of chest and neck area; too immobilized; terribly weak; generalized body aches; muscles and joints from neck down; general muscle and joint pain; significant chills/teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak) and PAIN (generalized body aches) in a 75-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.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak), PAIN (generalized body aches), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering). At the time of the report, FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak), PAIN (generalized body aches), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) probably had slight temperature.         Reportedly, the same type of symptoms with the 2nd dose which received on 06Mar2021. At the time, Patient ignored the symptoms, had the same side effects, but just plowed through it. In both the booster and second dose, the symptoms started about 11-12 hours after administration of the vaccine. Reported no problems with the first dose. Patient reports he is on quite a bit of concomitant medications, but did not share which ones.   This case was linked to MOD-2021-402836 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mobility decreased, Myalgia, Pain
Clinical narrative: felt like he was freezing; sweating of chest and neck area; too immobilized; terribly weak; generalized body aches; muscles and joints from neck down; general muscle and joint pain; significant chills/teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak) and PAIN (generalized body aches) in a 75-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.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak), PAIN (generalized body aches), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering). At the time of the report, FREEZING PHENOMENON (felt like he was freezing), HYPERHIDROSIS (sweating of chest and neck area), MOBILITY DECREASED (too immobilized), ASTHENIA (terribly weak), PAIN (generalized body aches), MYALGIA (muscles and joints from neck down), ARTHRALGIA (general muscle and joint pain) and CHILLS (significant chills/teeth chattering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) probably had slight temperature.         Reportedly, the same type of symptoms with the 2nd dose which received on 06Mar2021. At the time, Patient ignored the symptoms, had the same side effects, but just plowed through it. In both the booster and second dose, the symptoms started about 11-12 hours after administration of the vaccine. Reported no problems with the first dose. Patient reports he is on quite a bit of concomitant medications, but did not share which ones.   This case was linked to MOD-2021-402836 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Vaccine schedule not followed, invalid dosing schedule.; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Vaccine schedule not followed, invalid dosing schedule.) 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 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 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Vaccine schedule not followed, invalid dosing schedule.). On 30-Nov-2021, EXTRA DOSE ADMINISTERED (Vaccine schedule not followed, invalid dosing schedule.) had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on left arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling on left arm). At the time of the report, PARAESTHESIA (Tingling on left arm) outcome was unknown.            The patient stated that he didn't had any major side effects and had tingling on their left arm. Reportedly, they were otherwise perfectly fine.  No Concomitant product use was reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Mental confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Mental confusion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 CONFUSIONAL STATE (Mental confusion). At the time of the report, CONFUSIONAL STATE (Mental confusion) outcome was unknown.            The reporter was calling on behalf of the patient who received their second dose of Moderna COVID-19 vaccine and had some mental confusion. It was also reported that the patient was on a lot of concomitant medications.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-402978 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Joint swelling, Vaccination site pain
Clinical narrative: Knees are swollen after booster shot; Can not walk after booster shot; Knees hurt after booster shot/Both shoulders hurting after booster shot; Injection site hurts after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knees are swollen after booster shot), GAIT INABILITY (Can not walk after booster shot), ARTHRALGIA (Knees hurt after booster shot/Both shoulders hurting after booster shot) and VACCINATION SITE PAIN (Injection site hurts after booster shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 045A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced JOINT SWELLING (Knees are swollen after booster shot), GAIT INABILITY (Can not walk after booster shot), ARTHRALGIA (Knees hurt after booster shot/Both shoulders hurting after booster shot) and VACCINATION SITE PAIN (Injection site hurts after booster shot). At the time of the report, JOINT SWELLING (Knees are swollen after booster shot), GAIT INABILITY (Can not walk after booster shot), ARTHRALGIA (Knees hurt after booster shot/Both shoulders hurting after booster shot) and VACCINATION SITE PAIN (Injection site hurts after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.