chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Heavy menstrual bleeding, Inappropriate schedule of product administration, Interchange of vaccine products, Off label use
Clinical narrative: UNEXPECTED POSTPARTUM RESUMPTION OF MENSTRUAL CYCLE WITH HEAVY BLEEDING; BACK PAIN; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient by a Business partner (Pfizer Inc.) on 12-NOV-2021 was received on 12-NOV-2021 and concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia areata, and other pre-existing medical conditions included: In previous postpartum (twice) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced drug allergy when treated with fluconazole, and sulfamethoxazole. The patient was gravida 3, para 3. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 11:00 for prophylactic vaccination. Non-company suspect vaccine included: bnt 162 ( batch number: FG3527, form of admin, route of admin, and were not reported) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 25-MAR-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 06-NOV-2021, the patient experienced unexpected postpartum resumption of menstrual cycle with heavy bleeding. On 06-NOV-2021, the patient experienced back pain. On an unspecified date, the pregnancy resulted in a live birth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of unexpected postpartum resumption of menstrual cycle with heavy bleeding and back pain was not reported. This report was non-serious. This parent/child case is linked to 20211137975.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: UNEXPECTED POSTPARTUM RESUMPTION OF MENSTRUAL CYCLE WITH HEAVY BLEEDING; BACK PAIN; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient by a Business partner (Pfizer Inc.) on 12-NOV-2021 was received on 12-NOV-2021 and concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia areata, and other pre-existing medical conditions included: In previous postpartum (twice) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced drug allergy when treated with fluconazole, and sulfamethoxazole. The patient was gravida 3, para 3. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 11:00 for prophylactic vaccination. Non-company suspect vaccine included: bnt 162 ( batch number: FG3527, form of admin, route of admin, and were not reported) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 25-MAR-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 06-NOV-2021, the patient experienced unexpected postpartum resumption of menstrual cycle with heavy bleeding. On 06-NOV-2021, the patient experienced back pain. On an unspecified date, the pregnancy resulted in a live birth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of unexpected postpartum resumption of menstrual cycle with heavy bleeding and back pain was not reported. This report was non-serious. This parent/child case is linked to 20211137975.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Dry skin, Ulcer
Clinical narrative: Ulcer; Dry skin; Chills; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on MAY-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: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date to MAY-2021 for moderate to severe chronic plaque psoriasis, and psoriatic arthritis. No concomitant medications were reported.  On MAY-2021, the patient experienced chills. On an unspecified date, the patient experienced ulcer, and dry skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from chills on MAY-2021, and had not recovered from ulcer, and dry skin. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood blister, Chills, Platelet count
Clinical narrative: TINY BLOOD SPOTS SIZE OF A UNSHARPENED PENCIL ON BREAST, ARM, STOMACH AND LEG; CHILLS; WEAKNESS; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 108 pounds, and height was 62 inches. The patient's concurrent conditions included: thrombocythemia (high platelets), easy bruising, vegan, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with epinephrine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient experienced chills. On 30-MAR-2021, the patient experienced weakness. On JUL-2021, the patient experienced tiny blood spots size of a unsharpened pencil on breast, arm, stomach and leg. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiny blood spots size of a unsharpened pencil on breast, arm, stomach and leg, and chills, and weakness on 02-APR-2021. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced fatigue, and ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and ache. This report was non-serious. This case, involving the same patient is linked to 20211151493.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID19 INFECTION; DEATH; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 76 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 not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total was administered to right arm on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. About the first week of OCT-2021, the patient felt ill and went to an urgent care, performed rapid test result came negative, two days later he went to the ears, nose, throat (ENT) with worsening symptoms, and had another rapid test still negative. On 15-OCT-2021, the patient went to the hospital and was feeling severely ill, he was critical in the hospital and did polymerase chain reaction (PCR) test and tested positive (confirmed clinical vaccination failure, confirmed covid19 infection (acute hypoxia)), by then he was advanced and had significant lung damage. The number of hospitalized day was unspecified. On 03-NOV-2021, the patient died from unknown cause of death. An autopsy was not performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal and outcome of confirmed clinical vaccination failure and confirmed covid19 infection was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20211152663. This report was associated with product quality complaint.; Sender's Comments: V0: 20211151782-Covid-19 vaccine ad26.cov2.s-Confirmed 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   20211151782-Covid-19 vaccine ad26.cov2.s-Death, Confirmed covid19 infection . 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS THROUGH THE ROOF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 23-NOV-2021, the patient experienced tinnitus through the roof. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tinnitus through the roof was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-OCT-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: PCR (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20211151782.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Illness, Pain
Clinical narrative: GOT REALLY SICK; BODY PAIN; FAST HEART RATE; NUMBNESS ON FINGERS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got really sick, body pain, fast heart rate, and numbness on fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from got really sick, body pain, fast heart rate, and numbness on fingers. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Unevaluable event
Clinical narrative: ALMOST DIED AT MIDNIGHT; ALMOST KILL HER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-NOV-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 22-NOV-2021, the patient experienced almost died at midnight. On 22-NOV-2021, the patient experienced almost kill her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost died at midnight and almost kill her was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration, Insomnia, Muscle spasms
Clinical narrative: HARD TIME SLEEPING; MUSCLE SPASMS; COVID-19; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 7 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received ibrutinib (tablet, oral, batch number was not reported) 420 mg, 1 time every 1 day, therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, and dose was not reported, administered on MAR-2021 for covid-19 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 MAR-2021, the patient experienced inappropriate schedule of vaccine administered. On SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced hard time sleeping, and muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ibrutinib was not changed. The patient was recovering from covid-19, and muscle spasms, and the outcome of hard time sleeping and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no medical history. 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-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO A 15 YEAR OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 year old female. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient experienced vaccine administered to a 15 year old. On 24-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to a 15 year old was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: HORRIBLE HEALTH PROBLEMS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 horrible health problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible health problems was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: unknown) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned a 28 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known prior issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered 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 died after vaccination from unknown cause of death. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211154617.; Sender's Comments: V0: 20211154559-Covid-19 vaccine ad26.cov2.s- Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED APPROXIMATELY 24 HOURS AFTER INITIAL VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a physician concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: 11-DEC-2021) dose was not reported, administered on 24-NOV-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced incorrect product storage. On 24-NOV-2021, the patient experienced vaccine administered approximately 24 hours after initial vial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered approximately 24 hours after initial vial puncture and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS THAT COULD NOT WARM UP; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 200 pounds, and height was 69 inches. The patient's concurrent conditions included: diabetic, alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient is on blood pressure pill. The patient experienced nauseous and sick when treated with cefalexin for drug used for unknown indication, and diarrhea and throwing up when treated with potassium citrate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced chills that could not warm up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills that could not warm up on 09-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20211152000.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: LITTLE SICK; This spontaneous report received from a parent 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 not reported, batch number: Unk) 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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211154706.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE PAIN IN THE ARM; 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 not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 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 little pain in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little pain in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211154673 and 20211155653.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 24-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: CAN NOT MOVE ARM AFTER GETTING COVID-19 VACCINE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 can not move arm after getting covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can not move arm after getting covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211043237.
Sex: U
Vaccine: COVID19
Symptoms: Neurosis
Clinical narrative: NEUROSIS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced neurosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurosis was not reported. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; ADMINISTRATION OF EXPIRED VACCINE; VACCINE WAS ADMINISTERED 16 YEAR OLD PATIENT; This spontaneous report received from a parent concerned a 16 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient experienced off label use. On 24-NOV-2021, the patient experienced administration of expired vaccine. On 24-NOV-2021, the patient experienced vaccine was administered 16 year old subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine, vaccine was administered 16 year old patient and off label use was not reported. This report was non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Fatigue, Oxygen saturation decreased
Clinical narrative: feeling dizzy; any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains; felt tired; slight increase in joint soreness; oxygen at 85/ oxygen level has again dropped to mid 80's; Oxygen levels down to mid 80s; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), OXYGEN SATURATION DECREASED (Oxygen levels down to mid 80s), OXYGEN SATURATION DECREASED (oxygen at 85/ oxygen level has again dropped to mid 80's), DYSPNOEA (any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains) and FATIGUE (felt tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lung disease (Small vessel lung disease), Breathing difficult and Arthritis. Concomitant products included GUAIFENESIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OXYGEN SATURATION DECREASED (Oxygen levels down to mid 80s). On 18-Nov-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen at 85/ oxygen level has again dropped to mid 80's). On an unknown date, the patient experienced DIZZINESS (feeling dizzy), DYSPNOEA (any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains), FATIGUE (felt tired) and ARTHRALGIA (slight increase in joint soreness). At the time of the report, DIZZINESS (feeling dizzy), OXYGEN SATURATION DECREASED (oxygen at 85/ oxygen level has again dropped to mid 80's), DYSPNOEA (any MODERATE exertions eg, walking at a moderate pace or making a bed were met with shortness of breath which still remains) and FATIGUE (felt tired) had not resolved, OXYGEN SATURATION DECREASED (Oxygen levels down to mid 80s) had resolved and ARTHRALGIA (slight increase in joint soreness) outcome was unknown.            Other Concomitant medications include: Asthma medication for lungs. No Treatment medications were reported. She had a normally scheduled mammogram, and did her mammogram after the vaccination, which she said she was told by her HCP they did not recommend to receive a mammogram close to the time of vaccination.   This case was linked to MOD-2021-387946, MOD-2021-018630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Added the new events and current medical condition (Arthritis).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear pain, Inflammation, Myoclonus, Tinnitus
Clinical narrative: Middle ear muscle myoclonus; tinnitus/loud buzzing in right ear/ringing; inflammation/vaccination caused inflammation/believe i have auditory nerve inflammation; sharp pain in my ears/Ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (sharp pain in my ears/Ear pain), TINNITUS (tinnitus/loud buzzing in right ear/ringing), INFLAMMATION (inflammation/vaccination caused inflammation/believe i have auditory nerve inflammation) and MYOCLONUS (Middle ear muscle myoclonus) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Poison ivy rash (treatment drug Prednisone from 22-Apr-2021 to 02-May-2021) since 22-Apr-2021.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced EAR PAIN (sharp pain in my ears/Ear pain). On 23-Apr-2021, the patient experienced TINNITUS (tinnitus/loud buzzing in right ear/ringing) and INFLAMMATION (inflammation/vaccination caused inflammation/believe i have auditory nerve inflammation). On 08-Nov-2021, the patient experienced MYOCLONUS (Middle ear muscle myoclonus). The patient was treated with IVERMECTIN on 26-Sep-2021 for Inflammation, at an unspecified dose and frequency; VITAMINS NOS at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 15-Jul-2021 for Inflammation, at an unspecified dose and frequency; MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) on 03-Aug-2021 for Inflammation, at an unspecified dose and frequency; CALCIUM on 08-Nov-2021 for Myoclonus, at an unspecified dose and frequency and POTASSIUM on 08-Nov-2021 for Myoclonus, at an unspecified dose and frequency. At the time of the report, EAR PAIN (sharp pain in my ears/Ear pain) had resolved, TINNITUS (tinnitus/loud buzzing in right ear/ringing) had not resolved and INFLAMMATION (inflammation/vaccination caused inflammation/believe i have auditory nerve inflammation) and MYOCLONUS (Middle ear muscle myoclonus) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Acoustic stimulation tests: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states before vaccination patient didn't have any ear problem , allergies, tinnitus and  anxiety. On 3rd may 2021 patient field a report with VAERS.  Recently, patient did a hearing test and result said patient has normal hearing  Concomitant product was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow-up information included Patient details, Allergy, lab data,  treatment drugs, new event and its outcome.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Housebound, Vomiting
Clinical narrative: Violent vomiting 8-9 times a day; Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking; Could not get out of house; Extreme headache/was more severe for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking), HOUSEBOUND (Could not get out of house), HEADACHE (Extreme headache/was more severe for 2 weeks) and VOMITING (Violent vomiting 8-9 times a day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 029A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine allergy) since 01-May-2021, Drug allergy (All pain medications) since 01-May-2005 and Back pain since 10-Oct-2016. Concomitant products included MONTELUKAST from 05-Jan-2019 to 28-Oct-2021 and BIOTIN for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced DIZZINESS (Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking), HOUSEBOUND (Could not get out of house) and HEADACHE (Extreme headache/was more severe for 2 weeks). On 08-Nov-2021, the patient experienced VOMITING (Violent vomiting 8-9 times a day). On 11-Nov-2021, VOMITING (Violent vomiting 8-9 times a day) had resolved. On 13-Nov-2021, HOUSEBOUND (Could not get out of house) and HEADACHE (Extreme headache/was more severe for 2 weeks) had resolved. At the time of the report, DIZZINESS (Woke up very dizzy/ still wakes up dizzy in the morning, which normally goes away after a few hours/was more severe for 2 weeks/ now slight upon waking) had not resolved.            Concomitant medications include multivitamins and edlderberry 100 mg. Patient received flu vaccine injection on left arm on 18Oct2021.  No treatment information was provided   This case was linked to MOD-2021-388568 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contain no new information. On 22-Nov-2021: Significant Follow up received on 22-Nov-2021 contains medical history and concomitants updated and event onset and end date updated for vomiting.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Mild breakthrough case of COVID, tested positive on Sunday; drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild breakthrough case of COVID, tested positive on Sunday) and DRUG INEFFECTIVE (drug ineffective) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J22A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced COVID-19 (Mild breakthrough case of COVID, tested positive on Sunday) and DRUG INEFFECTIVE (drug ineffective). On 14-Nov-2021, DRUG INEFFECTIVE (drug ineffective) had resolved. At the time of the report, COVID-19 (Mild breakthrough case of COVID, tested positive on Sunday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient started having symptoms 4 days ago and tested positive on Sunday. He had no treatment or hospitalization. No concomitant medications was reported. No treatment drug details was reported.  Company Comment: This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19; drug ineffective was considered as an additional event. The event occurred 9 months 26 days after the first dose of mRNA-1273 vaccine and 8 months 28 days after the second dose. It was reported that no treatment or hospitalization was required. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 69-year-old male patient with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID 19; drug ineffective was considered as an additional event. The event occurred 9 months 26 days after the first dose of mRNA-1273 vaccine and 8 months 28 days after the second dose. It was reported that no treatment or hospitalization was required. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). In November 2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was opened on Sunday 14-Nov-2021. Vial did not undergo temperature excursions. Dates of administration of vaccine: 14-Nov-2021 6 doses and 15-Nov-2021 6 doses. Total 13 patients who received expired vaccines.  No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received Includes additional information - total number of patient received expired vaccine was updated to 13 (previously 12). On 23-Nov-2021: Follow up received contains Non Significant Information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia
Clinical narrative: Terrible flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Terrible flu like symptoms) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Terrible flu like symptoms) and PYREXIA (Fever). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Terrible flu like symptoms) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) 102 degree temperature.         Concomitant product information includes daily vitamins   This case was linked to MOD-2021-388755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received and contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had mederna-19 vaccine shots and recently contacted Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had mederna-19 vaccine shots and recently contacted Covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had mederna-19 vaccine shots and recently contacted Covid-19). At the time of the report, COVID-19 (Had mederna-19 vaccine shots and recently contacted Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. This case concerns a patient with unknown age and gender, with no medical history reported, who experienced non serious unexpected AESI of COVID-19 after dose of mRNA-1273. No information regarding start date of the event neither vaccination dates. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient with unknown age and gender, with no medical history reported, who experienced non serious unexpected AESI of COVID-19 after dose of mRNA-1273. No information regarding start date of the event neither vaccination dates. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: mild case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of COVID-19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COVID-19 (mild case of COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (mild case of COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This spontaneous case concerns a 82-year-old female patient with no details on relevant medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred approximately 5 months after the second dose of mRNA- 1273 vaccine. Clinical manifestations included headache and fatigue. The rechallenge is not applicable due to the nature of the event. Patient´s age is a risk factor for severe COVID-19, but nevertheless the patient experienced mild disease.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Drug ineffective was not captured since information regarding the appropriateness of the schedule of vaccination is not available at this moment.