chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deep vein thrombosis, Weight, Weight decreased
Clinical narrative: THROMBOSIS IN FEMORAL VEIN; WEIGHT LOSS; COVID-19; This spontaneous report received from a patient via other manufacturer concerned a 76 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: osteoarthritis, and concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: 1165105 expiry: unknown, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient had blood clots following the Johnson and Johnson vaccination. The patient was not sure if Rinvoq influenced this too. The patient's left leg and foot were swollen. The clot was in the femoral vein (thrombosis in femoral vein) (dose number in series 1). The patient was hospitalized and placed on blood thinners and was recovered from this. The patient took a blood thinner. The patient had noticed weight loss (dose number in series 1) since starting Rinvoq and was not losing it drastically but had lost overall 30 pounds. The patient was not sure whether the Rinvoq was the reason but felt that the weight loss began with the Rinvoq. The patient remarks that she had energy. The patient had covid three times and the last infection was in JUN or JUL of 2022 (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient recovered from thrombosis in femoral vein, and covid-19 on 2022, and was recovering from weight loss. The patient additionally received Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine (elasomeran) (dose number in series 2). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220860077-covid-19 vaccine ad26.cov2.s - thrombosis in femoral vein. This event(s) is labeled per database and is therefore considered potentially related.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Expired product administered, Urinary incontinence
Clinical narrative: EXPIRED VACCINE ADMINISTERED; UNCONTROLLED PEEING; UNCONTROLLED POOPING/DIARRHEA; This spontaneous report received from a patient concerned a 73 year old male. The patient's weight was 160 pounds, and height was 185.42 centimeters. The patient's past medical history included: arthritic pain (went away when took Orgain), dizziness (went away when took Orgain), eye surgery (done in both eyes and now have 20/20 vision.), and vision issues, and concurrent conditions included: type 2 diabetes (using medications from 5-6 years ago), cipro allergy, alcohol use (a beer every few months), and non-smoker, and other pre-existing medical conditions included: The patient was using medications for the heart attack 5-6 years ago. The patient have never gotten COVID. The patient was previously treated with carbohydrates nos/fats nos/minerals nos/proteins nos/vitamins nos.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 18-FEB-2022) dose was not reported, administered on 06-MAY-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 73 years old. Concomitant medications included ascorbic acid, ergocalciferol, and zinc.  On MAY-2022, the patient experienced uncontrolled peeing, and uncontrolled pooping/diarrhea. On 06-MAY-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled peeing, and uncontrolled pooping/diarrhea, and the outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220861185.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tachycardia
Clinical narrative: TACHYCARDIA; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient previously received two doses of covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on 01-MAR-2021 and 01-JUN-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 01 total, administered on 01-MAR-2022 for covid-19 prophylaxis. Age at time of vaccination 72 years old. 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 01-JUN-2022 (3 months after vaccination), the patient experienced tachycardia (dose number in series 2). The patient received non-company suspect drugs included (Skyrizi) risankizumab (form of admin unknown, subcutaneous, batch number: unknown and expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable and dose of risankizumab was not changed. The patient had not recovered from tachycardia. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Illness, Tremor
Clinical narrative: GOT SICK RIGHT THERE ON THE SPOT; TREMBLING; COULDN'T GET UP AND WALK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got sick right there on the spot, trembling, and couldn't get up and walk. The action taken with covid-19 vaccine was not applicable. The patient was recovering from got sick right there on the spot, trembling, and couldn't get up and walk. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: ARM REACTIONS; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis (ms). The patient experienced bad arm reactions when treated with influenza vaccine, and pneumococcal vaccine for prophylactic vaccination.  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 covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm reactions. The action taken with covid-19 vaccine was not applicable. The outcome of arm reactions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Body temperature, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: VERY SWEATY; LOW GRADE FEVER; FELT TIRED; AMENORRHEA; 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 past medical history included: drug addiction (The patient had been 4 and half years clean from drug addiction), and other pre-existing medical conditions included: The patient had no known allergies. The patient was not pregnant at the time of vaccination and was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 250A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced amenorrhea. On 09-APR-2021, the patient experienced felt tired. On 10-APR-2021, the patient experienced very sweaty, and low grade fever. Laboratory data included: Body temperature Low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sweaty, low grade fever, and felt tired, and was recovering from amenorrhea. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body mass index, Lethargy, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; LETHARGY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 45 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: body mass index (32 BMI) and iodine allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. Patient was on other medication or products within 2 weeks of starting covid-19 treatment. The patient received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported and has been requested. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine (Dose number in series 1). The patient received non-company suspect vaccine Moderna/Spikevax (dose number in series 2) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine Moderna/Spikevax (Dose number in series 2). The patient received non-company suspect vaccine Pfizer (tozinameran) (dose number in series 3) (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered at left arm on 24-JUL-2022 16:00 for covid-19 prophylaxis. Concomitant medications included lisdexamfetamine mesilate.  The patient took non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 11-AUG-2022 and last dose on 16-AUG-2022 for treatment of covid 19. On 22-AUG-2022 at 15:00, six days after taking paxlovid the patient experienced cough, runny nose, shortness of breath with difficulty breathing fever (suspected covid-19 infection) and lethargy (dose number in series 3). Currently the patient was on day 16 since the first symptom and feels like she was getting worse. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and tozinameran was not applicable and with paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection and lethargy. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) and concerned a 36 year old female. The patient's height and weight were not reported. The patient's past medical history included: surgery for retinal detachment and concurrent conditions included: asthma, depression and sulfa drug allergy. The patient was not pregnant at the time of vaccination. 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, expiry: unknown) dose was not reported, 1 total administered to the left arm on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 34 years old. Concomitant medications included bupropion (drug started on NOV-2020). The patient also received non-company suspect vaccine included: Moderna covid-19 vaccine (dose number in series 2) (form of administration, route of administration and batch number were not reported, expiry: unknown) dose was not reported, administered to the left arm on OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 35 years old. The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 15-AUG-2022 to 19-AUG-2022 for treatment of COVID-19. It was reported that the patient had rebound covid after finishing the Paxlovid and tested negative for two days on 20-AUG-2022 and on 21-AUG-2022, after finishing the treatment. The patient mentioned on 22-AUG-2022, the third day in the raw, she tested positive without symptoms (coded as suspected covid-19 infection) (dose number in series 2).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable, (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; LOW GRADE FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not 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 AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 18 years old. No concomitant medications were reported. On an unspecified date, the patient experienced headache, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and low grade fever was not reported. This report was non-serious. This parent/child case is linked to 20220901617.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: TIGHTNESS IN CHEST; LEGS SWELL; LEGS HURT MORE AS THE WEEKS GO BY; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 muscle pain, tightness in chest, legs swell, and legs hurt more as the weeks go by. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, tightness in chest, legs swell and legs hurt more as the weeks go by was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: CHANGE IN LIVES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. 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 change in lives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of change in lives was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED COVID-19; This spontaneous report received from a patient via a company representative concerned a 71 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series: 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after booster dose, the patient contracted covid-19 from one of her relatives (dose number in series 2). The patient had nothing more than a runny nose. She was very pleased with the results of getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000248991.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Weight
Clinical narrative: Condition aggravated/FLARE UPS; Modera first dose of on FEB-2021 and second dose on SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated/FLARE UPS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Modera first dose of on FEB-2021 and second dose on SEP-2021) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and PREDNISONE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Modera first dose of on FEB-2021 and second dose on SEP-2021). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated/FLARE UPS). At the time of the report, CONDITION AGGRAVATED (Condition aggravated/FLARE UPS) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Modera first dose of on FEB-2021 and second dose on SEP-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.  Patient experienced HUMIRA NOT HELPING with HUMIRA (ADALIMUMAB)  The reporter's causality for the event(s) of FLARE UPS and WEIGHT GAIN with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of HUMIRA NOT HELPING was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2022, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. Patient reported that they was testing positive for Covid and was not contagious. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected non-serious event of (AESI) Covid-19. The exact date of administration of the second and third dose of mRNA-1273 was not specified, hence latency could not be assessed. Patient tested positive for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637093, US-MODERNATX, INC.-MOD-2022-637094, US-MODERNATX, INC.-MOD-2022-637095 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected non-serious event of (AESI) Covid-19. The exact date of administration of the second and third dose of mRNA-1273 was not specified, hence latency could not be assessed. Patient tested positive for SARS COV-2. No further details on clinical course and treatment received were reported. Outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. US-MODERNATX, INC.-MOD-2022-637094:Patient 2 US-MODERNATX, INC.-MOD-2022-637093:Patient 1 US-MODERNATX, INC.-MOD-2022-637095:Patient 3
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient received 1st dose of moderna and week and a half ago caught COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID). At the time of the report, COVID-19 (Patient received 1st dose of moderna and week and a half ago caught COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that tested positive for COVID and that not contagious. The reporter mentions the children were eligible to get their second dose.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a 4-year-old male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred 22 days after receiving the first dose of mRNA-1273.  The clinical presentation, clinical course and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-637093, US-MODERNATX, INC.-MOD-2022-637095, US-MODERNATX, INC.-MOD-2022-637089 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 4-year-old male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred 22 days after receiving the first dose of mRNA-1273.  The clinical presentation, clinical course and treatment information were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-637093:Patient 1 US-MODERNATX, INC.-MOD-2022-637095:Patient 3 US-MODERNATX, INC.-MOD-2022-637089:Reporter's case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose 3 months after first booster; Stuffy nose 3 months after first booster; Sore Throat 3 months after first booster; Mild Temperature 3 months after first booster; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster). At the time of the report, RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Body temperature: Mild Temperature 3 months after first booster. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant product use was not provided by the reporter.  The patient received first booster dose of Moderna COVID-19 vaccine three months prior to the date of this report on 23-Apr-2022. She had runny nose, stuffy nose, sore throat, and mild temperature.   As per her pharmacist, she was due for the second booster dose.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Runny nose 3 months after first booster; Stuffy nose 3 months after first booster; Sore Throat 3 months after first booster; Mild Temperature 3 months after first booster; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster). At the time of the report, RHINORRHOEA (Runny nose 3 months after first booster), NASAL CONGESTION (Stuffy nose 3 months after first booster), OROPHARYNGEAL PAIN (Sore Throat 3 months after first booster) and PYREXIA (Mild Temperature 3 months after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Body temperature: Mild Temperature 3 months after first booster. On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Concomitant product use was not provided by the reporter.  The patient received first booster dose of Moderna COVID-19 vaccine three months prior to the date of this report on 23-Apr-2022. She had runny nose, stuffy nose, sore throat, and mild temperature.   As per her pharmacist, she was due for the second booster dose.   Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Costochondritis
Clinical narrative: rib/nerve/cartilage problem called costochondriti/very painful; This spontaneous case was reported by a patient and describes the occurrence of COSTOCHONDRITIS (rib/nerve/cartilage problem called costochondriti/very painful) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COSTOCHONDRITIS (rib/nerve/cartilage problem called costochondriti/very painful). The patient was treated with METHYLPREDNISOLONE for Inflammation, at a dose of 4 milligram. At the time of the report, COSTOCHONDRITIS (rib/nerve/cartilage problem called costochondriti/very painful) outcome was unknown.            Concomitant products were not reported.  It was reported that patient received primary series and two boosters from Moderna, first booster on 27-Oct-2021. Patient was diagnosed with costochondritis months later, few weeks after having the booster dose.   This case was linked to MOD-2021-337936, MOD-2021-338018 (Patient Link).   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration; No adverse event; Expired vaccine administered to patients; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) and PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator/HCP did not know but states that vaccines are usually put in refrigerator a week before administration).    No concomitant drug was reported. It was reported that patient was administered to 7 patients past the expiration date, from Moderna lot number 033K21-2A with an expiration date of 20MAY2022. The patients not reported any adverse reactions. HCP did not know but stated that vaccines were usually put in refrigerator a week before administration. Vial did not undergoes temperature excursion. No Treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was kept in refrigerator a week before administration; No adverse event; Vaccine expired on 20-May-2022 and was administered on 16-Jun-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 and was administered on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 and was administered on 16-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 and was administered on 16-Jun-2022), PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 20-May-2022 and was administered on 16-Jun-2022) and PRODUCT STORAGE ERROR (Expired vaccine was kept in refrigerator a week before administration).    Concomitant drugs were not reported.  The patient received second booster dose.  The patient had not reported any adverse reactions.  Number of doses/vials were 7 doses/1 vial.  It was reported that the reporter did not know when the vial was initially stored but states that vaccines were usually put in refrigerator a week before administration.   The vial did not undergo any temperature excursion.  Treatment medications were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunodeficiency
Clinical narrative: patient does not have any immunity left; Feels vulnerable; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (patient does not have any immunity left) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (patient does not have any immunity left) (seriousness criterion medically significant) and FEELING ABNORMAL (Feels vulnerable). At the time of the report, IMMUNODEFICIENCY (patient does not have any immunity left) and FEELING ABNORMAL (Feels vulnerable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case reported by a consumer concerns an 80-year-old female patient, with no reported medical history, who experienced unexpected, serious (medically significant) event immunodeficiency, after receiving a dose of mRNA-1273.  Onset latency of event from time of vaccination could not be determined due to limited information.  Clinical course, diagnostic evaluation, concomitant medications, and treatment not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns an 80-year-old female patient, with no reported medical history, who experienced unexpected, serious (medically significant) event immunodeficiency, after receiving a dose of mRNA-1273.  Onset latency of event from time of vaccination could not be determined due to limited information.  Clinical course, diagnostic evaluation, concomitant medications, and treatment not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient recieved first dose on 10-Dec-2020 and second dose on 15-Jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient recieved first dose on 10-Dec-2020 and second dose on 15-Jan-2021) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (moderate to severe).   On 10-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient recieved first dose on 10-Dec-2020 and second dose on 15-Jan-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient recieved first dose on 10-Dec-2020 and second dose on 15-Jan-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment details were reported.   This case was linked to MOD-2022-637343 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear discomfort, Immunisation reaction, Inappropriate schedule of product administration, Sinus disorder
Clinical narrative: Cough; REACTION TO MODERNA COVID SHOT; SINUS ISSUES; EAR CLOGGED; First dose 1-Nov-2021 and second dose 1-Feb-2022; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), IMMUNISATION REACTION (REACTION TO MODERNA COVID SHOT), SINUS DISORDER (SINUS ISSUES), EAR DISCOMFORT (EAR CLOGGED) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 1-Nov-2021 and second dose 1-Feb-2022) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) for an unknown indication and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On 01-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Feb-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient received dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced COUGH (Cough), IMMUNISATION REACTION (REACTION TO MODERNA COVID SHOT), SINUS DISORDER (SINUS ISSUES), EAR DISCOMFORT (EAR CLOGGED) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 1-Nov-2021 and second dose 1-Feb-2022). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, COUGH (Cough), SINUS DISORDER (SINUS ISSUES) and EAR DISCOMFORT (EAR CLOGGED) was resolving and IMMUNISATION REACTION (REACTION TO MODERNA COVID SHOT) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 1-Nov-2021 and second dose 1-Feb-2022) outcome was unknown.            The reporter's causality for the evens of cough, sinus issues and ear clogged with Co-suspect Imbruvica (Ibrutinib) was probable whereas not reported with vaccination adverse reaction (Immunisation reaction). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: excruciating pain on the left side of her body; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (excruciating pain on the left side of her body) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061B22A, 078J21A, 032B21A and 002A21A) 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (excruciating pain on the left side of her body). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, MYALGIA (excruciating pain on the left side of her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The event caused the patient to seek medical care.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Skin swelling, Urticaria
Clinical narrative: itching; hives all over their body; looks like red blotches; skin is raised; gets red lines; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), SKIN SWELLING (skin is raised), ERYTHEMA (gets red lines), URTICARIA (hives all over their body) and RASH MACULAR (looks like red blotches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 053E21A and 929892) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, the patient experienced PRURITUS (itching) and URTICARIA (hives all over their body). In 2022, the patient experienced SKIN SWELLING (skin is raised), ERYTHEMA (gets red lines) and RASH MACULAR (looks like red blotches). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK, bid. At the time of the report, PRURITUS (itching), SKIN SWELLING (skin is raised), ERYTHEMA (gets red lines), URTICARIA (hives all over their body) and RASH MACULAR (looks like red blotches) had not resolved.            Patient had no medical history reported and no allergy were reported. Patient height was reported as 5' . Ten days after receiving the Booster vaccine, patient experienced  itching with hives all over their body. Patient reports that when scratching it, the skin gets raised with the appearance of red lines, which looks like red blotches. They are still experiencing it. They takes allergy pills twice a day (Zyrtec) which helps to a certain degree. They went to an allergist and they said they have nothing.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Myalgia
Clinical narrative: Muscle aches/Body aches; Minor side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 0021321A) for COVID-19 prophylaxis.     The patient's past medical history included Ulcer NOS (past medical history of ulcers, so patient could not take any NSAIDS and could only take Tylenol). Concurrent medical conditions included Fibromyalgia (Diagnosed about 15 years ago).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Muscle aches/Body aches). In 2021, the patient experienced IMMUNISATION REACTION (Minor side effect). At the time of the report, IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) outcome was unknown.            The patient was used to the body aches and achiness as the patient had a medical history of fibromyalgia.  No concomitant medications were reported.  The patient had the same minor side effect after the first two shots of Moderna vaccine. The patient had no leg weakness after the first two shots of Moderna vaccine.  About 7 or 8 hours later after vaccination with the two shots, the patient had some body aches and muscle aches.  No treatment medications were reported.   This case was linked to MOD-2022-637940 (Patient Link).