chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling hot, Peripheral coldness, Sensitive skin, Skin disorder
Clinical narrative: SKIN FEELS WET (WHEN GETS IN BED, GOTTEN WORSE); HANDS HYPERSENSITIVE TO COLD AND HOT (LIKE WHEN WASHES, ALMOST LIKE DAGGERS); STRANGE AND UNCOMFORTABLE (NOT LIFE THREATENING); LEG, BACK, ARMS, FEET ARE SENSITIVE (WHEN WALKS, IF WALKS BAREFOOT FEETS ARE SENSITIVE TO TEMPERATURE)/ EXTREMITIES SENSITIVE; ODD SENSATION ON SKIN (LIKE A MENTHOL COOLING SENSATION)/SKIN FEELS COLD(WHEN GETS IN BED, GOTTEN WORSE); WARM SENSATION ON LEGS,THIGHS TO CALVES, AND SPREAD TO BACK AND ARMS (NOT ALL HAPPEN AT THE SAME TIME AND FEELS EXTREMELY SENSITIVE WHEN TOUCHES LIKE HER GRANITE COUNTERTOP); This spontaneous report received from a patient concerned a 57 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced odd sensation on skin (like a menthol cooling sensation) /skin feels cold (when gets in bed, gotten worse). On SEP-2021, the patient experienced warm sensation on legs, thighs to calves, and spread to back and arms (not all happen at the same time and feels extremely sensitive when touches like her granite countertop). On an unspecified date, the patient experienced skin feels wet (when gets in bed, gotten worse), hands hypersensitive to cold and hot (like when washes, almost like daggers), strange and uncomfortable (not life threatening), and leg, back, arms, feet are sensitive (when walks, if walks barefoot feets are sensitive to temperature) / extremities sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the odd sensation on skin (like a menthol cooling sensation)/skin feels cold(when gets in bed, gotten worse), warm sensation on legs,thighs to calves, and spread to back and arms (not all happen at the same time and feels extremely sensitive when touches like her granite countertop), skin feels wet (when gets in bed, gotten worse), hands hypersensitive to cold and hot (like when washes, almost like daggers), strange and uncomfortable (not life threatening) and leg, back, arms, feet are sensitive (when walks, if walks barefoot feets are sensitive to temperature)/ extremities sensitive was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature intolerance
Clinical narrative: SKIN FEELS WET (WHEN GETS IN BED, GOTTEN WORSE); HANDS HYPERSENSITIVE TO COLD AND HOT (LIKE WHEN WASHES, ALMOST LIKE DAGGERS); STRANGE AND UNCOMFORTABLE (NOT LIFE THREATENING); LEG, BACK, ARMS, FEET ARE SENSITIVE (WHEN WALKS, IF WALKS BAREFOOT FEETS ARE SENSITIVE TO TEMPERATURE)/ EXTREMITIES SENSITIVE; ODD SENSATION ON SKIN (LIKE A MENTHOL COOLING SENSATION)/SKIN FEELS COLD(WHEN GETS IN BED, GOTTEN WORSE); WARM SENSATION ON LEGS,THIGHS TO CALVES, AND SPREAD TO BACK AND ARMS (NOT ALL HAPPEN AT THE SAME TIME AND FEELS EXTREMELY SENSITIVE WHEN TOUCHES LIKE HER GRANITE COUNTERTOP); This spontaneous report received from a patient concerned a 57 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced odd sensation on skin (like a menthol cooling sensation) /skin feels cold (when gets in bed, gotten worse). On SEP-2021, the patient experienced warm sensation on legs, thighs to calves, and spread to back and arms (not all happen at the same time and feels extremely sensitive when touches like her granite countertop). On an unspecified date, the patient experienced skin feels wet (when gets in bed, gotten worse), hands hypersensitive to cold and hot (like when washes, almost like daggers), strange and uncomfortable (not life threatening), and leg, back, arms, feet are sensitive (when walks, if walks barefoot feets are sensitive to temperature) / extremities sensitive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the odd sensation on skin (like a menthol cooling sensation)/skin feels cold(when gets in bed, gotten worse), warm sensation on legs,thighs to calves, and spread to back and arms (not all happen at the same time and feels extremely sensitive when touches like her granite countertop), skin feels wet (when gets in bed, gotten worse), hands hypersensitive to cold and hot (like when washes, almost like daggers), strange and uncomfortable (not life threatening) and leg, back, arms, feet are sensitive (when walks, if walks barefoot feets are sensitive to temperature)/ extremities sensitive was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 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: 201A21A, expiry: unknown) dose was not reported, 1 total administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient underwent reverse transcriptionpolymerase chain reaction (RT PCR) test and result found to be positive for delta variant (confirmed covid-19 infection) (confirmed clinical vaccination failure). On the same date she also had COVID-19 antigen test and result found to be positive for Covid-19 infection. It was also reported that on an unspecified date she had a high fever, cough, muscles and joint pain terrible pain that lasted for 6 or 7 days. She had no other respiratory symptoms and her oxygen level was ok. It was mild Covid but symptomatic. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20211015754 -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
Age: 79.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus, Rash
Clinical narrative: ITCHINESS; RASH TO ARMS, LEGS AND SHOULDERS THAT WAS SPREADING; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's past medical history included: rash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-MAR-2021 for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 itchiness, and rash to arms, legs and shoulders that was spreading. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from itchiness, and had not recovered from rash to arms, legs and shoulders that was spreading. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: SEVERE MUSCLE SPASMS; SEVERE MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 severe muscle spasms, and severe muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe muscle pain and severe muscle spasms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HIGH FEVER; 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: 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 high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: ALWAYS FEEL HOT; CONSTANT ITCHING ALL OVER; BRAIN FOG DAILY; LOSS OF ENERGY; EXHAUSTED; INTENSE HEADACHE; 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: 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 always feel hot, constant itching all over, brain fog daily, loss of energy, exhausted, and intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense headache, loss of energy, exhausted, always feel hot, constant itching all over and brain fog daily was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ALWAYS FEEL HOT; CONSTANT ITCHING ALL OVER; BRAIN FOG DAILY; LOSS OF ENERGY; EXHAUSTED; INTENSE HEADACHE; 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: 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 always feel hot, constant itching all over, brain fog daily, loss of energy, exhausted, and intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense headache, loss of energy, exhausted, always feel hot, constant itching all over and brain fog daily was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pain
Clinical narrative: NOSE BLEEDS; NORMAL BODY ACHING; This spontaneous report received from a patient via a company representative concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced nose bleeds. On OCT-2021, the patient experienced normal body aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nose bleeds and normal body aching was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Intentional dose omission
Clinical narrative: refused to get my 2nd shot until I feel better; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and INTENTIONAL DOSE OMISSION (refused to get my 2nd shot until I feel better) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3154818694) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (refused to get my 2nd shot until I feel better). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and INTENTIONAL DOSE OMISSION (refused to get my 2nd shot until I feel better) had resolved.        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 refused to get his 2nd shot until he feels better. He already went to his doctor and he did not believe that it was from the vaccine and did not prescribed any medications.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: left arm  became red like the size of her palm; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm  became red like the size of her palm) and FEELING HOT (Hot to the touch) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left arm  became red like the size of her palm) and FEELING HOT (Hot to the touch). At the time of the report, ERYTHEMA (left arm  became red like the size of her palm) and FEELING HOT (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was stated it been 2 weeks since she got her 1st shot and this the first time she has seen it.   No concomitant medications were provided. No treatment medications were provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered to patient from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered to patient from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. The vaccine vial was on refrigerator from 25-Aug-2021 (8 days prior).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up contains patient's demographics and product details.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021). In September 2021, EXPIRED PRODUCT ADMINISTERED (20 doses of expired vaccine were given between 2Sep2021 and 24SEP2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that dose of expired  was vaccine received  between 02-Sep-2021 and 24-Sep-2021.  Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received  contains non significant information updated reporter contact details. On 05-Oct-2021: follow-up includes no new information.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.  Company comment: This case concerns a patient of unknown age and gender, with no previous relevant medical history reported, who experienced the unexpected event of Bell´s palsy. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a patient of unknown age and gender, with no previous relevant medical history reported, who experienced the unexpected event of Bell´s palsy. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Mild soreness at the injection site; I was really, really tired & fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatic fever (as a kid).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued). At the time of the report, VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. Patient hip replacement surgery scheduled in October and doctors had recommended it. the patient experiencing mild soreness at the injection site and was really, really tired  and fatigued.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Upon follow-up source document contain future surgery details updated in Inarrative supplement.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door). At the time of the report, PRODUCT STORAGE ERROR (received frozen Moderna covid-19 vaccine that was stored in a freezer which did not have a separate freezer door) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Malaise, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: she felt sick all over again; felt dizzy immediately following the dose (10-15 min later); did not feel good; left arm as being warm to the touch; a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose; left arm was very painful for day,rolling over on that arm hurt (she would jump up); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch), THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)). At the time of the report, ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.  No treatment drugs were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: she felt sick all over again; felt dizzy immediately following the dose (10-15 min later); did not feel good; left arm as being warm to the touch; a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose; left arm was very painful for day,rolling over on that arm hurt (she would jump up); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch), THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)). At the time of the report, ILLNESS (she felt sick all over again), DIZZINESS (felt dizzy immediately following the dose (10-15 min later)), MALAISE (did not feel good), VACCINATION SITE WARMTH (left arm as being warm to the touch) and VACCINATION SITE PAIN (left arm was very painful for day,rolling over on that arm hurt (she would jump up)) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (a reoccurring bump on her head by she hairline that would come back after before getting the vaccine, went away after getting the dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.  No treatment drugs were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine beyond 30 days  on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days  on the fridge) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days  on the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days  on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Second dose and first dose details were not reported Expired doses of the Moderna vaccine was administered to 25 patients. The vials were in refrigerator for over 30 days. Number of doses per vials on 27-Sep-2021 1 vials of 14 doses and on 29-Sep-2021, 1 vial, 11 doses. Date the vial was initially stored in the refrigerator is on 24-Aug-2021. Dates of administration of vaccine on 27-Sep-2021 and 29-Sep-2021.   This case was linked to MOD-2021-338604 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received vaccine beyond 30 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037F21A) for COVID-19 immunization. No medical history reported. On Sep 27, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 27, 2021, patient administered expired product (received vaccine beyond 30 days). At the time of the report, administered expired product (received vaccine beyond 30 days) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-338604 (patient link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Thermal burn
Clinical narrative: Left shoulder burned; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURN (Left shoulder burned) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced THERMAL BURN (Left shoulder burned) and HEADACHE (Headache). At the time of the report, THERMAL BURN (Left shoulder burned) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided. No concomitant medication was provided   This case was linked to MOD-2021-338314, MOD-2021-338407 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vaccine used; Patients received vaccines that went through excursions twice; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Patients received vaccines that went through excursions twice) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced PRODUCT STORAGE ERROR (Patients received vaccines that went through excursions twice). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 03-Sep-2021, PRODUCT STORAGE ERROR (Patients received vaccines that went through excursions twice) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Gait inability, Headache, Inappropriate schedule of product administration
Clinical narrative: Lower body weakness; Neck pain; legs couldn't stand; Inability to walk; Weakness of legs; terrified of the BOOSTER.; Head pain; Fever; Body pain/Severe body aches; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk) and MUSCULAR WEAKNESS (Weakness of legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 8077727399) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive.). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), ANXIETY (terrified of the BOOSTER.), HEADACHE (Head pain), PYREXIA (Fever) and MYALGIA (Body pain/Severe body aches). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASTHENIA (Lower body weakness), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), HEADACHE (Head pain) and PYREXIA (Fever) had not resolved and NECK PAIN (Neck pain), ANXIETY (terrified of the BOOSTER.) and MYALGIA (Body pain/Severe body aches) outcome was unknown.            Patient height was 5'2" and weight was 220. No treatment medications were reported.   This case was linked to MOD-2021-338873 (RA Linked Report). This case was linked to MOD-2021-023159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains Updated suspect product details. Added new events and concomitant medications and patient medical history. On 05-Oct-2021: Follow up received on 06 oct 2021 contains NNI.; Sender's Comments:  MOD-2021-338873:Dose 2
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness, Myalgia, Neck pain, Pyrexia
Clinical narrative: Lower body weakness; Neck pain; legs couldn't stand; Inability to walk; Weakness of legs; terrified of the BOOSTER.; Head pain; Fever; Body pain/Severe body aches; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk) and MUSCULAR WEAKNESS (Weakness of legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 8077727399) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive.). Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASTHENIA (Lower body weakness), NECK PAIN (Neck pain), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), ANXIETY (terrified of the BOOSTER.), HEADACHE (Head pain), PYREXIA (Fever) and MYALGIA (Body pain/Severe body aches). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASTHENIA (Lower body weakness), LIMB DISCOMFORT (legs couldn't stand), GAIT INABILITY (Inability to walk), MUSCULAR WEAKNESS (Weakness of legs), HEADACHE (Head pain) and PYREXIA (Fever) had not resolved and NECK PAIN (Neck pain), ANXIETY (terrified of the BOOSTER.) and MYALGIA (Body pain/Severe body aches) outcome was unknown.            Patient height was 5'2" and weight was 220. No treatment medications were reported.   This case was linked to MOD-2021-338873 (RA Linked Report). This case was linked to MOD-2021-023159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains Updated suspect product details. Added new events and concomitant medications and patient medical history. On 05-Oct-2021: Follow up received on 06 oct 2021 contains NNI.; Sender's Comments:  MOD-2021-338873:Dose 2
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient reported- administered vaccine one day after past expiry date.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains Pregnancy data, Race, Ethnic Group, Vaccine Route & body site updated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048f21a) for COVID-19 vaccination.     The patient's past medical history included Panic attack.    On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Myalgia, at an unspecified dose and frequency. On 06-Sep-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant was not specified.   This case was linked to MOD-2021-339110.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pyrexia, Vaccination site erythema
Clinical narrative: has a scab where the needle was introduced/ like a pimple where the needle was introduced; headache; tiredness; fever; had "the red arm"; itchy where the needle was introduced; Possibly getting first and second dose too close; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (had "the red arm") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm"), VACCINATION SITE PRURITUS (itchy where the needle was introduced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close). At the time of the report, VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm") and VACCINATION SITE PRURITUS (itchy where the needle was introduced) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  treatment medications were not reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site scab
Clinical narrative: has a scab where the needle was introduced/ like a pimple where the needle was introduced; headache; tiredness; fever; had "the red arm"; itchy where the needle was introduced; Possibly getting first and second dose too close; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (had "the red arm") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm"), VACCINATION SITE PRURITUS (itchy where the needle was introduced) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close). At the time of the report, VACCINATION SITE SCAB (has a scab where the needle was introduced/ like a pimple where the needle was introduced), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE ERYTHEMA (had "the red arm") and VACCINATION SITE PRURITUS (itchy where the needle was introduced) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Possibly getting first and second dose too close) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  treatment medications were not reported.   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath"; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 038c21a) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient added that he can't do things without running out of breath). Concomitant products included PARACETAMOL (TYLENOL) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath"). At the time of the report, DYSPNOEA (shortness of breath, started again and became persistent & debilitating, he "can't do things without running out of breath") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient reported being on Sedatives medication and Stomach medication.