chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Nucleic acid test, SARS-CoV-2 test, SARS-CoV-2 test negative, Vaccination failure
Clinical narrative: COVID-19 INFECTION; CONFIRMED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight, height, and medical history were not reported. Past  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, injection site left arm) dose not reported received on 08-APR-2021 for COVID-19 prophylaxis. Co-suspect medication included Moderna COVID-19 prophylaxis vaccination (solution for injection, intramuscular, batch number 066F21A, injection site left arm), unspecified dose received on 14-NOV-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAY-2022 the patient experienced initial COVID symptoms and confirmed clinical vaccine failure .  On 11-MAY-2022 the patient had positive nucleic acid amplification test (NAAT) cue test.  On 11-MAY-2022 the patient started treatment with Paxlovid (nirmatrelvir tablets, ritonavir tablets), from 11-MAY-2022 till 16-MAY-2022 as COVID-19 treatment.  By 14-MAY-2022 the patient was symptom free. On 20-MAY-2022 the patient had a negative COVID-19 antigen test.  On 22-MAY-2022 the patient experienced mild cold like symptoms and had a positive COVID-19 antigen test.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 infection, confirmed clinical vaccine failure was not recovered. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 44 year old patient experienced covid-19 infection and confirmed clinical vaccine failure, approximately 13 months after receiving Janssen covid-19 vaccine (6 months after receiving Moderna COVID-19 prophylaxis vaccination). The events show an incompatible temporal relationship. Therefore, the events are considered not related to Janssen covid-19 vaccine .
Age: 31.0
Sex: F
Vaccine: COVID19, 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 via other manufacturer Pfizer concerned a 33 year old  female. Initial information was processed with the additional information received on 07-JUN-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, depression, and sulfa drugs allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 in right arm for prophylactic vaccination. Age at time of vaccination 31 years old.  The patient additionally received non-company suspect vaccine included: Moderna (spikevax) vaccine (elasomeran) (dose number in series 2) (form of admin, and route of admin were not reported, batch number: 071F21A expiry: UNKNOWN) dose was not reported, administered on 04-NOV-2021 in right arm for prophylactic vaccination. Concomitant medications included fluticasone propionate/salmeterol xinafoate, levosalbutamol, spironolactone, valaciclovir and decongestant cough suppressant/expectorant with nasal.   On an unspecified date in MAY-2022, patient reported that symptoms never fully disappeared, still had a cough. On 18-MAY-2022, the patient was prescribed with Paxlovid (nirmatrelvir and ritonavir) for covid-19 treatment. Patient received last dose of Paxlovid on 22-MAY-2022. On 23-MAY-2022, patient had moderate shortness of breath in addition to cough but she tested negative. Laboratory data included: COVID-19 virus test Negative. Symptoms continued all week. On 27-MAY-2022, patient tested positive again, no change in symptoms (confirmed covid-19 infection (dose number in series 2), which led to confirmed clinical vaccination failure (dose number in series 1).  Laboratory data included: COVID-19 virus test Positive. Patient was still experiencing same symptoms on 28-MAY-2022. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0-20220609449-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache
Clinical narrative: BLOOD COMING DOWN FROM NOSTRILS; TERRIBLE HEADACHES; 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, 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 blood coming down from nostrils, and terrible headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible headaches and blood coming down from nostrils was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Full blood count
Clinical narrative: SUBCONJUNCTIVAL HEMORRHAGE IN THE RIGHT AND LEFT EYE; This spontaneous report received from a health care professional concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure, migraine headache, fibromyalgia, Benadryl allergy, non-smoker, non-alcoholic and other pre-existing medical conditions included: Patient had no any drug abuse or illicit drug usage. Patient was seen by HCP on 04-NOV-2020. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced subconjunctival hemorrhage in the right and left eye. It was stated that, patient had been seen twice by HCP (physician office visit), two other HCP saw her in summer and fall of last year. On 25-JUN-2021, probably was the first visit. Patient's HCP reported that she had a subconjunctival hemorrhage in the right eye (on 04-JUN-2022), it was about the 20th time that was happening since patient had her vaccine, it was in the right eye but it had been in left and right eyes, patient had her blood work checked twice with her HCP (complete blood count) CBC to determine if patient had any bleeding disorder and it came back as normal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from subconjunctival hemorrhage in the right and left eye. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220609898 -Covid-19 vaccine ad26.cov2.s -SUBCONJUNCTIVAL HEMORRHAGE . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; 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 previously received first dose of covid-19 vaccine ad26. cov2 (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The patient had the only real side effect and had experienced from the original vaccine (Dose number in series 1) was some fatigue following vaccination with the first dose of covid-19 vaccine ad26. cov2 (Dose number in series 1). The outcome of fatigue was reported as recovered/resolved (Dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown ) dose was not reported, 1 total administered on 26-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm, and headache with the booster (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220613253 (Dose number in series 1).
Age: 29.0
Sex: M
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 via other manufacturer (Pfizer) concerned a 30 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: dairy allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 29 years old. No concomitant medications were reported.  On an unspecified date in MAY-2022, the patient tested positive for Covid (confirmed covid-19 infection which led to confirmed clinical vaccination failure). Laboratory data included: COVID-19 virus test Positive. On 16-MAY-2022, he started Paxloid shortly after testing positive for COVID and took last dose on 20-MAY-2022. After about a week, he tested negative and his symptoms had nearly fully subsided. Laboratory data included: COVID-19 virus test Negative.  After about 2 weeks since getting COVID, he started testing positive again and remained positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220610317-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 60 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 13-FEB-2021, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series: 1) (suspension for injection, route of admin, batch number: 1805031, expiry: 21-JAN-2022), dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series: 1).  On 22-OCT-2021, the patient previously received covid-19 vaccine ad26. cov2.s (dose number in series: 2) (suspension for injection, route of admin, batch number: 1822811, expiry: 17-AUG-2022), dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series: 2).  On 03-JUN-2022, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 3) (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 24-SEP-2022) dose was not reported, 1 total administered for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered. Age at time of vaccination 60 years old. No concomitant medications were reported. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Unevaluable event
Clinical narrative: PSORIASIS BREAKOUT ALL OVER BODY; THREW HIS ENTIRE BODY OUT OF WHACK; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-AUG-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 (injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 49 years old.  No concomitant medications were reported.  On an unspecified date, the patient experienced psoriasis breakout all over body, and threw his entire body out of whack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from psoriasis breakout all over body, and threw his entire body out of whack. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age. Initial information was processed with additional information received on 08-JUN-2022. 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was very sick with covid (coronavirus disease) (thus experienced suspected clinical vaccination failure and suspected covid-19 infection). As per reporter, "our son-in-law was forced to get the vaccine or be fired. He chose j and j and it did not work too well for him. He is now very sick with covid". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20220610790-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has an unknown/unclear 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: LITTLE TIREDNESS; This spontaneous report received from a patient (Nurse) concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a nurse. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number and expiry date unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose was not reported, 1 total, administered in right arm on 2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2022, the patient experienced little tiredness (Dose number in series 2). Patient stated that, a little tiredness a day after taking her booster J and J covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Malaise
Clinical narrative: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; DOES NOT FEEL BETTER AFTER RESTING/ NOT FEELING WELL; ENERGY LEVEL DOES LIMIT DAILY ACTIVITIES (ASTHENIA); FATIGUE/ SYMPTOMS OF FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced loss of personal independence in daily activities, does not feel better after resting/ not feeling well, energy level does limit daily activities (asthenia), and fatigue/ symptoms of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the energy level does limit daily activities (asthenia), fatigue/ symptoms of fatigue, does not feel better after resting/ not feeling well and loss of personal independence in daily activities was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Tinnitus
Clinical narrative: SENSATION OF RINGING IN BOTH EARS (TINNITUS); NASAL CONGESTION; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, and other pre-existing medical conditions included: Patient had no illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 01-MAR-2022) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. Age at time of vaccination 22 years old. No concomitant medications were reported. On 01-JUL-2021, the patient experienced nasal congestion. On 15-JUL-2021, the patient experienced sensation of ringing in both ears (tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal congestion on 08-JUL-2021, and had not recovered from sensation of ringing in both ears (tinnitus). This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: CHILLS; FEVER; VOMITED; This spontaneous report received from a parent concerned a 27 year old female of unknown race and ethnic origin. 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: 1805022 and expiry: unknwon) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. No concomitant medications were reported. On 07-MAR-2021, the patient experienced chills, fever, and vomited (dose number in series 1). The outcome of the fever, chills and vomited was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received Non-company suspect vaccine included: Tozinameran (Comirnity) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for an unspecified indication. On an unspecified date, the events reoccurred such as fever, chills and vomited after the series 1 (dose number in series 2). The patient received Non-company suspect vaccine included: Elasomeran (Spikevax) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAY-2022 for an unspecified indication. On an unspecified date, the patient experienced lit bit of fever and did not vomited (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and vomited was not reported. This report was non-serious. This case, from the same reporter is linked to 20220562331.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus
Clinical narrative: LICHEN PLANUS/BLISTERS WITH EVERY MEAL; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lichen planus/blisters with every meal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lichen planus/blisters with every meal was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: WEIRD BUT NON SERIOUS COVID-19 VACCINE SIDE EFFECT; This spontaneous report received from a consumer 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced weird but non serious covid-19 vaccine side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weird but non serious covid-19 vaccine side effect was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy 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 pre-existing medical conditions included: Patient received the J and J Covid-19 Vaccine and 1 month later discovered that she was pregnant. The patient was gravida 1, para 1. 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 vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in a live birth. The patient gave birth to a baby of unspecified sex. Birth outcome was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious. This parent/child case is linked to 20220617386.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Pancreatitis (manifestation by pancreatitis), Abstains from alcohol, Wheezing (manifestation by wheezing) and Oral surgery. Concurrent medical conditions included Dry mouth ("There was a unspecified medication that caused the dry mouth and was told by the physician that crohn's disease might also caused dry mouth.") since 2012, Drug allergy (Methotrexate allergy), Non-smoker, Drug allergy (imuran allergy), Drug allergy (asacol allergy) and Crohn's disease.   In 2014, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate Free (1- 2 wk). On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  It was reported that the patient had oral surgery. She also had flu like symptoms and fatigue due to covid vaccine, and missed two weeks of work and three weeks with one. Patient underwent root canal three to four times in Jan2022 and Mar2022. She underwent root canal because of dry mouth. There was a unspecified medication that caused dry mouth and was told by the physician that Crohn's disease might also cause dry mouth. The dry mouth did not worsen she started taking Humira. It was unknown if patient was enrolled in Covid-19 vaccine trail.  No treatment information provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: A patient received a booster dose instead of the 2nd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the 2nd full dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Apr-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the 2nd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the 2nd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No side effects reported. No treatment medication was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After 1st booster patient felt pain in her arm for a week and a half; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After 1st booster patient felt pain in her arm for a week and a half) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 030A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to cephalosporines) and Allergy to intravenous contrast media (Allergic to IV contrast). Concomitant products included GABAPENTIN for Migraine, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (After 1st booster patient felt pain in her arm for a week and a half). On 20-Nov-2021, PAIN IN EXTREMITY (After 1st booster patient felt pain in her arm for a week and a half) had resolved.     Treatment information was not provided.   This case was linked to MOD-2022-584152, MOD-2022-584154, MOD-2022-584156.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: vaccinated and boosted an got COVID.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (vaccinated and boosted an got COVID.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 025L20A and 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (vaccinated and boosted an got COVID.). At the time of the report, COVID-19 (vaccinated and boosted an got COVID.) outcome was unknown.            No concomitant information was reported. It was reported that they are finishing their quarantine at the time of reporting. No treatment information was provided.  Company comment: This spontaneous case concerns an elderly male patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received 2 more doses of mRNA-1273 vaccine 9 and 10 months prior to the last dose. Details about date of diagnosis, investigations, treatment, clinical course and event outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received 2 more doses of mRNA-1273 vaccine 9 and 10 months prior to the last dose. Details about date of diagnosis, investigations, treatment, clinical course and event outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Sleeping all the time; Patient was shaking; Muscle aches; Joint aches; Very bad headache; Patient had chills; Fever; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleeping all the time), TREMOR (Patient was shaking), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches) and HEADACHE (Very bad headache) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 (Patient didn't get tested, but believes had COVID on March 2022) in March 2022. Concurrent medical conditions included Gluten sensitivity and Nickel sensitivity.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleeping all the time), TREMOR (Patient was shaking), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches), HEADACHE (Very bad headache), CHILLS (Patient had chills) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleeping all the time), TREMOR (Patient was shaking), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches), HEADACHE (Very bad headache), CHILLS (Patient had chills) and PYREXIA (Fever) outcome was unknown.            Concomitant mediations were not reported.   There weren't any other vaccines given to the patient within 1 month prior to the Moderna CVIS-19 vaccine.  Patient states that symptoms were very intense for first 24 hours.  For treatment patient took her own medicine.   This case was linked to MOD-2022-584256.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: Sleeping all the time; Patient was shaking; Muscle aches; Joint aches; Very bad headache; Patient had chills; Fever; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Sleeping all the time), TREMOR (Patient was shaking), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches) and HEADACHE (Very bad headache) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 (Patient didn't get tested, but believes had COVID on March 2022) in March 2022. Concurrent medical conditions included Gluten sensitivity and Nickel sensitivity.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleeping all the time), TREMOR (Patient was shaking), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches), HEADACHE (Very bad headache), CHILLS (Patient had chills) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleeping all the time), TREMOR (Patient was shaking), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches), HEADACHE (Very bad headache), CHILLS (Patient had chills) and PYREXIA (Fever) outcome was unknown.            Concomitant mediations were not reported.   There weren't any other vaccines given to the patient within 1 month prior to the Moderna CVIS-19 vaccine.  Patient states that symptoms were very intense for first 24 hours.  For treatment patient took her own medicine.   This case was linked to MOD-2022-584256.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise
Clinical narrative: big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise; This spontaneous case was reported by a patient and describes the occurrence of ADMINISTRATION SITE BRUISE (big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M204 and 013M204) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. Patient was not given any vaccines within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose number).  Concurrent medical conditions included Drug allergy (Cotrimoxa, motrin, naproxen, trazodone Hydrochloride.) and Allergy to antibiotic (clindamycin).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced ADMINISTRATION SITE BRUISE (big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise). At the time of the report, ADMINISTRATION SITE BRUISE (big old bruise on her shoulder, where the shot was giving, the size of a tennis ball, a big bruise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication reported as diabetes medication.  It was also reported that the patient did not had any symptoms.  AE did not cause patient to seek medical care. The patient did not experience a similar event in the past.  No treatment details reported.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 30Dec2021 and doses were administered on 11Mar2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine put in the fridge on 30Dec2021 and doses were administered on 11Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 30Dec2021 and doses were administered on 11Mar2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. It was reported that, the patient received total 3 doses and this was booster dose. On 30-Dec-2021, the vials were initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided. This case was linked to MOD-2022-584679, MOD-2022-584680 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up information was received includes patient demographics and primary reporter details were updated. New event product storage error was added and event verbatim of expired vaccine used was updated.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Initially vaccine was stored in fridge on 07 Feb 2022and was administered on 20 APR 2022 after more than 30 days; Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07 Feb 2022and was administered on 20 APR 2022 after more than 30 days) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07 Feb 2022and was administered on 20 APR 2022 after more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07 Feb 2022and was administered on 20 APR 2022 after more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. It was reported that, the patient received total 3 doses and this was booster dose. Vial did not undergo any temperature excursions. No treatment medications were provided.   This case was linked to MOD-2022-584679, MOD-2022-584673 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up information was received includes patient demographics, event product storage error added and reporter details updated.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.* No concomitant medication was reported. It was reported that vaccine was administered to total of 24 patients including 15 males and 9 females. HCP reported administrations were mostly for booster shots. No side effects reported. No treatment information were reported.
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Long COVID-19.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection). At the time of the report, POST-ACUTE COVID-19 SYNDROME (shots worsened the prolonged symptoms, he experienced from a previous COVID-19 infection) had not resolved.            No concomitant drug reported. No treatment information was provided by the reporter.