chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Discomfort, Grip strength decreased, Joint effusion
Clinical narrative: FLUID IN JOINTS; TENDONITIS; STIFFNESS; DIFFICULTY GRABBING; JOINT INFLAMMATION IN WRISTS, ANKLES, ELBOWS AND HIP (LOWER BACK); FELT LIKE SHE HAD LIFTED HEAVY WEIGHT; MUSCLE SORENESS IN THE BACK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraine, and rash, and concurrent conditions included: sulpa allergy, alcohol user, non-smoker, and drug allergy, and other pre-existing medical conditions included: Patient did no drug abuse or illicit drug usage. The patient was previously treated with phenobarbital, and hydrocodone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced muscle soreness in the back, and felt like she had lifted heavy weight. On JUN-2021, the patient experienced joint inflammation in wrists, ankles, elbows and hip (lower back). On an unspecified date, the patient experienced fluid in joints, tendonitis, stiffness, and difficulty grabbing. Laboratory data (dates unspecified) included: Blood test NOS (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) showed fluid in joints. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fluid in joints, had not recovered from joint inflammation in wrists, ankles, elbows and hip (lower back), stiffness, and difficulty grabbing, and the outcome of muscle soreness in the back, tendonitis and felt like she had lifted heavy weight was not reported. This report was non-serious. This case, from the same reporter is linked to 20211263625 and 20211240486.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Tendonitis, Ultrasound scan
Clinical narrative: FLUID IN JOINTS; TENDONITIS; STIFFNESS; DIFFICULTY GRABBING; JOINT INFLAMMATION IN WRISTS, ANKLES, ELBOWS AND HIP (LOWER BACK); FELT LIKE SHE HAD LIFTED HEAVY WEIGHT; MUSCLE SORENESS IN THE BACK; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraine, and rash, and concurrent conditions included: sulpa allergy, alcohol user, non-smoker, and drug allergy, and other pre-existing medical conditions included: Patient did no drug abuse or illicit drug usage. The patient was previously treated with phenobarbital, and hydrocodone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the patient experienced muscle soreness in the back, and felt like she had lifted heavy weight. On JUN-2021, the patient experienced joint inflammation in wrists, ankles, elbows and hip (lower back). On an unspecified date, the patient experienced fluid in joints, tendonitis, stiffness, and difficulty grabbing. Laboratory data (dates unspecified) included: Blood test NOS (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) showed fluid in joints. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fluid in joints, had not recovered from joint inflammation in wrists, ankles, elbows and hip (lower back), stiffness, and difficulty grabbing, and the outcome of muscle soreness in the back, tendonitis and felt like she had lifted heavy weight was not reported. This report was non-serious. This case, from the same reporter is linked to 20211263625 and 20211240486.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. Patient was a healthy man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on OCT-2021 for prophylactic vaccination (Dose number series 1). The batch number was not reported and has been requested. No concomitant medications were reported. After receiving the vaccine on unspecified date in OCT-2021, patient experienced Guillain Barre syndrome. He was in hospital (admitted on an unspecified date) for 8 days and was in ton of pain. Physician said that it would take patient 2 to 3 years to be back to normal. Patient looked older than his 92 years old father. He walked with a cane or walker. He experienced horrible life at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20211264251-COVID-19 VACCINE AD26.COV2.S-Guillaine Barre Syndrome. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 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 not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 23-OCT-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Patient tested positive for COVID-19 with both home kit rapid test and a nose swab test that she took at her physicians office. Patient was not sure if the nose swab test that she took at her doctor's office was a PCR  (polymerase chain reaction) test.  Patient stated tested positive twice and HCP (health care professional) diagnosed with COVID-19. Patient had symptoms of fever, cough and chills an aches in body that started 28-DEC-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000209379.; Sender's Comments: V0- 20211264268-Covid-19 vaccine ad26.CoV-2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Malaise
Clinical narrative: BURNING SENSATION IN BREAST; NOT FEELING WELL/DID NOT FEEL GOOD; This spontaneous report received from a patient 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 was not reported, administered on 12-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On DEC-2021, the patient experienced burning sensation in breast, and not feeling well/did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well/did not feel good and burning sensation in breast was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Dizziness, Headache, Tinnitus
Clinical narrative: DIZZINESS; OTHER SYMPTOMS; TINNITUS; DAILY HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient. 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 dizziness, other symptoms, tinnitus and daily headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus, daily headaches, dizziness and other symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: BODY ACHES; STIFF NECK; FEVER OF 101; POUNDING HEADACHE; This spontaneous report received from a parent via a company representative concerned a female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. 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 29-DEC-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 30-DEC-2021, the patient experienced body aches, stiff neck, fever of 101, and pounding headache. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101, body aches, stiff neck and pounding headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: gall bladder issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, dose number in series 1, 1 total, 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 got covid while in the hospital for a gall bladder issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209597.; Sender's Comments: V0: 20211265966-COVID-19 VACCINE AD26.COV2.S- Got COVID. 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: Pain in extremity
Clinical narrative: LITTLE SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced little sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: RECEIVED FIRST DOSE OF MODERNA AND THEN HAD JASSEN VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced hospitalization when treated with mrna 1273 for prophylactic vaccination. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced received first dose of moderna and then had jassen vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and received first dose of moderna and then had jassen vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: MORE SYMPTOMATIC (PSORIASIS FLARES UP MORE)  WITH THE COVID-19 VACCINE; This spontaneous report received from a consumer concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. 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 more symptomatic (psoriasis flares up more) with the covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of more symptomatic (psoriasis flares up more) with the covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient 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, expiry: unknown) dose 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series was 1). 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 30-DEC-2021, the patient experienced suspected covid-19 infection (cough, fever, runny nose, congestion nasal and sneezing). Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211265944. This case was associated with product quality complaint number.; Sender's Comments: V0: 20211266272-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 28 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 211AZ1A, 211A21A expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-DEC-2021, the patient had symptoms of chills and fatigue while she was at work and thought the chills were due to low temperatures at work but then she left work early due to fatigue and tested positive with a rapid test at home. On 30-DEC-2021, the patient reports symptoms of cough, fatigue and chills and took another home test and tested positive again (coded as suspected clinical vaccination failure and suspected covid-19 infection). The patient had not taken a polymerase chain reaction test nor have seen a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20211266275-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID 19 TEST POSITIVE; This spontaneous report received from a patient concerned a 44 year old male. 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: 0U2A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-DEC-2021, the patient experienced covid 19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 test positive was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature abnormal
Clinical narrative: TEMPERATURE EXCURSION; 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of temperature excursion was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 45 year old male. 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 24-AUG-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 24-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Skin disorder
Clinical narrative: A SPOT SHOW UP AFTER VACCINE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no relevant medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On 2021, the patient experienced a spot show up after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from a spot show up after vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced CHILLS (Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again). At the time of the report, CHILLS (Patient started having chills for about 2 months in her arms, shoulders throughout her body, to her legs/Chills went away and started back up again) had not resolved.            No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Patient stated that she was oncerned with chills recur and may not get the 3rd dose.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given the 1st dose of the Moderna Covid-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given the 1st dose of the Moderna Covid-19 vaccine). On 28-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given the 1st dose of the Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Faecaloma
Clinical narrative: Could not go to the bathroom on his own; "fecal matter had gotten in a crease of his butt and he was deathly ill."; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Could not go to the bathroom on his own) and FAECALOMA ("fecal matter had gotten in a crease of his butt and he was deathly ill.") in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Could not go to the bathroom on his own) (seriousness criteria hospitalization and medically significant) and FAECALOMA ("fecal matter had gotten in a crease of his butt and he was deathly ill.") (seriousness criteria hospitalization and medically significant). At the time of the report, CONSTIPATION (Could not go to the bathroom on his own) and FAECALOMA ("fecal matter had gotten in a crease of his butt and he was deathly ill.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient went to hospital and had surgery. No relevant concomitant medications were reported. Treatment includes colostomy. Patient date of birth reported as 08-Aug-2021. Reporter informed her friend who was also getting a colonic and She states he could not go to the bathroom on his own. It turned out "fecal matter had gotten in a crease of his butt and he was deathly ill." He went to the hospital and had surgery. He had a colostomy. Company Comment: This case concerns a 61-year-old, male patient with no medical history reported, who experienced the unexpected serious events of Constipation and Faecaloma, for which the patient required hospitalization and a colostomy. The events occurred at an unknown day after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition and hospitalization.   This case was linked to MOD-2021-403110 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient with no medical history reported, who experienced the unexpected serious events of Constipation and Faecaloma, for which the patient required hospitalization and a colostomy. The events occurred at an unknown day after a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition and hospitalization.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (few patients more than 12 hours post vial puncture, specifically 4 days later.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H213) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (few patients more than 12 hours post vial puncture, specifically 4 days later.). On 12-Mar-2021, EXPIRED PRODUCT ADMINISTERED (few patients more than 12 hours post vial puncture, specifically 4 days later.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-435267, MOD-2021-435296, MOD-2021-435283, MOD-2021-435303, MOD-2021-435276, MOD-2021-435306, MOD-2021-435309, MOD-2021-435297, MOD-2021-435299, MOD-2021-435363, MOD-2021-435358, MOD-2021-435356, MOD-2021-435369, MOD-2021-435334, MOD-2021-435362, MOD-2021-435418, MOD-2021-435424, MOD-2021-435409 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up received on 20-Dec-2021 contains reporter's address and contact details has been updated. On 31-Dec-2021: Followup received added reporter details, added patient demographics, added suspect product details.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (recently testing positive for COVID), NASOPHARYNGITIS (Had a cold since end of November beginning of December.), DRUG INEFFECTIVE (lack of drug effect) and BRONCHITIS (bronchitis) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (Had a cold since end of November beginning of December.). On 15-Dec-2021, the patient experienced COVID-19 (recently testing positive for COVID) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced BRONCHITIS (bronchitis). At the time of the report, COVID-19 (recently testing positive for COVID), NASOPHARYNGITIS (Had a cold since end of November beginning of December.), DRUG INEFFECTIVE (lack of drug effect) and BRONCHITIS (bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Patient Went to the ER / stopped at the ER (on the way home from work as patient was not feeling good at work) and got diagnosed patient thought it was bronchitis but Tested positive for COVID December 15th.  Company Comment:  This is a spontaneous case of drug ineffective concerning a 48-year-old, female patient with unknown medical history, who experienced the unexpected non-serious event of bronchitis and nasopharyngitis and the non-serious AESI event of COVID-19. The patient tested positive for COVID, 7 months after the second dose of mRNA-1273 vaccine.  The rechallenge was not applicable since the events have not been reported after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of drug ineffective concerning a 48-year-old, female patient with unknown medical history, who experienced the unexpected non-serious event of bronchitis and nasopharyngitis and the non-serious AESI event of COVID-19. The patient tested positive for COVID, 7 months after the second dose of mRNA-1273 vaccine.  The rechallenge was not applicable since the events have not been reported after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a covid infection after being vaccinated) and DRUG INEFFECTIVE (drug ineffectiveness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, the patient experienced COVID-19 (I had a covid infection after being vaccinated) and DRUG INEFFECTIVE (drug ineffectiveness). On 20-Oct-2021, DRUG INEFFECTIVE (drug ineffectiveness) had resolved. At the time of the report, COVID-19 (I had a covid infection after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) positive. On an unknown date, SARS-CoV-2 antibody test: no antibodies (Negative) no antibodies.     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.  Company comment: This is a spontaneous case concerning a 71-year-old male  patient with no medical history reported, who experienced unexpected event of COVID-19; drug ineffective was considerer as an additional event. The events occurred approximately 8 months after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-114596, MOD-2021-114568 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 71-year-old male  patient with no medical history reported, who experienced unexpected event of COVID-19; drug ineffective was considerer as an additional event. The events occurred approximately 8 months after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation delayed
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (did not get a period up until 26Sep2021), HEAVY MENSTRUAL BLEEDING (they have their period, but is not stopping), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna vaccine dose was on 02Jun2021,the second dose was on 10Jul2021,) and HEAVY MENSTRUAL BLEEDING (lot of blood clots coming out) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna vaccine dose was on 02Jun2021,the second dose was on 10Jul2021,). In July 2021, the patient experienced MENSTRUATION DELAYED (did not get a period up until 26Sep2021). In September 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (lot of blood clots coming out). On 26-Sep-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (they have their period, but is not stopping). On 10-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first Moderna vaccine dose was on 02Jun2021,the second dose was on 10Jul2021,) had resolved. At the time of the report, MENSTRUATION DELAYED (did not get a period up until 26Sep2021), HEAVY MENSTRUAL BLEEDING (they have their period, but is not stopping) and HEAVY MENSTRUAL BLEEDING (lot of blood clots coming out) had not resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-435458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021; Cold Chills; Shakes; Low grade fever; Headache; Fatigue/ Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021). In February 2021, the patient experienced FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021) had resolved. In February 2021, FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-430596.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021; Cold Chills; Shakes; Low grade fever; Headache; Fatigue/ Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021). In February 2021, the patient experienced FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness). On 03-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 Vaccine (29Dec2020, lot #011J20A) Second dose was injected IM on 03Feb2021) had resolved. In February 2021, FEELING COLD (Cold Chills), TREMOR (Shakes), PYREXIA (Low grade fever), HEADACHE (Headache) and FATIGUE (Fatigue/ Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-430596.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Oropharyngeal pain
Clinical narrative: sore throat; feel sick; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ILLNESS (feel sick) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-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 OROPHARYNGEAL PAIN (sore throat), ILLNESS (feel sick) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), ILLNESS (feel sick) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that need to get tested to get back to work so they inquire if the test result may be affected by the vaccine    Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Updated reporter's Qualification and contains suspect product start date for booster shot 17-Dec-2021
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Worsening pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Worsening pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain. Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced PAIN (Worsening pain). At the time of the report, PAIN (Worsening pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021) 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.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021). In December 2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine beyond the 30 day use by date, 2 doses on 22Dec2021 and 2 doses on 23Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. Pharmacist reports that they received the shipment of the Moderna Covid-19 vaccine on 08Nov2021 and placed them in the refrigerator with the proper storage and lighting conditions. The health department found out that they misinterpreted the stability date of the vaccine. Pharmacist reported vials have been sitting in the refrigerator for more than 30 days and the administered 4 booster doses, two doses were on 22Dec2021 and 23Dec2021. Lot number/Expiration date - 013F21A.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised). On 26-Oct-2021, ACCIDENTAL UNDERDOSE (a patient received a Moderna Covid-19 Vaccine half dose booster on 26Oct2021 but should have received a full dose due to being immunocompromised) had resolved.        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.