chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Full body hives; tI's itchy, and it's all over, hands, face, neck, arm, legs, stomach; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Full body hives) and PRURITUS (tI's itchy, and it's all over, hands, face, neck, arm, legs, stomach) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), GABAPENTIN, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced URTICARIA (Full body hives) and PRURITUS (tI's itchy, and it's all over, hands, face, neck, arm, legs, stomach). At the time of the report, URTICARIA (Full body hives) and PRURITUS (tI's itchy, and it's all over, hands, face, neck, arm, legs, stomach) had not resolved.            Patient visited emergency room twice. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Sluggishness, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Reaction at the injection site; Warm to the touch but stated that she does not have fever; Feels sluggish; Sore arm; reaction at the injection site, it was red and stated that half-way down the arm, she has a big red blotch/it is all red and everything; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Reaction at the injection site), FEELING HOT (Warm to the touch but stated that she does not have fever), SLUGGISHNESS (Feels sluggish), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (reaction at the injection site, it was red and stated that half-way down the arm, she has a big red blotch/it is all red and everything) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 047B21A and 045A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu shots (she gets sore arm even with flu shots.). Past adverse reactions to the above products included Pain in arm with Flu shots.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Reaction at the injection site), FEELING HOT (Warm to the touch but stated that she does not have fever), SLUGGISHNESS (Feels sluggish), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (reaction at the injection site, it was red and stated that half-way down the arm, she has a big red blotch/it is all red and everything). The patient was treated with LEVOFLOXACIN (ALEEV) on 12-Dec-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Reaction at the injection site), FEELING HOT (Warm to the touch but stated that she does not have fever), SLUGGISHNESS (Feels sluggish), PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE ERYTHEMA (reaction at the injection site, it was red and stated that half-way down the arm, she has a big red blotch/it is all red and everything) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Patient stated that she had not yet had covid at all.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 12 year old received moderna dose as 2nd dose; 2 dose interchanged- got moderna instead of pfizer; wrong dosage used, 0.25 mL; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received moderna dose as 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose interchanged- got moderna instead of pfizer) and UNDERDOSE (wrong dosage used, 0.25 mL) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received moderna dose as 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose interchanged- got moderna instead of pfizer) and UNDERDOSE (wrong dosage used, 0.25 mL). On 09-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received moderna dose as 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose interchanged- got moderna instead of pfizer) and UNDERDOSE (wrong dosage used, 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided. Instead of receiving the Pfizer vaccine as 2nd dose, consumer was given a dose of Moderna covid-19. Expiration date was mentioned as  24 Mar 2021
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Rash erythematous, Vaccination site reaction
Clinical narrative: covid arm; red rash; dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash) and DIZZINESS (dizziness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash) and DIZZINESS (dizziness). At the time of the report, VACCINATION SITE REACTION (covid arm), RASH ERYTHEMATOUS (red rash) and DIZZINESS (dizziness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced ARTHRALGIA (Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting). At the time of the report, ARTHRALGIA (Every joint was hurting including her artificial ones,she was in such horrible pain/both arms, both wrists, both ankles and all of her joints are all hurting) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Felt bad for 3 days; Pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad for 3 days) and PAIN IN EXTREMITY (Pain in legs) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt bad for 3 days) and PAIN IN EXTREMITY (Pain in legs). At the time of the report, FEELING ABNORMAL (Felt bad for 3 days) had resolved and PAIN IN EXTREMITY (Pain in legs) outcome was unknown.            Concomitant medications were not provided Treatment medications were not provided Patient got booster dose last week.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm after the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after the injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20N, 031H21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-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 PAIN IN EXTREMITY (Sore left arm after the injection). At the time of the report, PAIN IN EXTREMITY (Sore left arm after the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Patient reports no adverse reaction after booster dose.  Treatment information was not provided.   This case was linked to MOD-2021-409816 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Product administration error
Clinical narrative: Patient is worried; Booster dose may have leaked out the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Patient is worried) and PRODUCT ADMINISTRATION ERROR (Booster dose may have leaked out the injection site) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Patient is worried) and PRODUCT ADMINISTRATION ERROR (Booster dose may have leaked out the injection site). At the time of the report, ANXIETY (Patient is worried) outcome was unknown and PRODUCT ADMINISTRATION ERROR (Booster dose may have leaked out the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Reporter stated that when the patient removed the bandage there was orange cloudy liquid in the middle of the bandage.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (Shortness of breath) 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 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph node right armpit after booster; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph node right armpit after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 018B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swelling of lymph node right armpit after booster). At the time of the report, LYMPHADENOPATHY (Swelling of lymph node right armpit after booster) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-028549 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Mild Fever after first shot; Mild Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever after first shot) and CHILLS (Mild Chills after first shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Leg cramps (Patient had a medical history of mild leg cramps that flared up every once in a blue moon).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (Mild Fever after first shot) and CHILLS (Mild Chills after first shot). On 09-Mar-2021, PYREXIA (Mild Fever after first shot) and CHILLS (Mild Chills after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-410071, MOD-2021-410072 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site at the painful my arm still hurts; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site at the painful my arm still hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site at the painful my arm still hurts). At the time of the report, VACCINATION SITE PAIN (injection site at the painful my arm still hurts) had not 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.   No concomitant medication was reported by reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Big red rash at the injection site; It was painful; developed big red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Big red rash at the injection site), VACCINATION SITE PAIN (It was painful) and VACCINATION SITE ERYTHEMA (developed big red rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H2HA) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE RASH (Big red rash at the injection site), VACCINATION SITE PAIN (It was painful) and VACCINATION SITE ERYTHEMA (developed big red rash at the injection site). At the time of the report, VACCINATION SITE RASH (Big red rash at the injection site), VACCINATION SITE PAIN (It was painful) and VACCINATION SITE ERYTHEMA (developed big red rash at the injection site) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Mild Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Leg cramps (Mild leg cramps that flared up every once in a blue moon).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Mild Fever) and CHILLS (Chills). On 10-Apr-2021, PYREXIA (Mild Fever) and CHILLS (Chills) had resolved.            Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-410043, MOD-2021-410072 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm was swollen for a day or two.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen for a day or two.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm was swollen for a day or two.). At the time of the report, PERIPHERAL SWELLING (Arm was swollen for a day or two.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 60-80, possibly more, administered expired moderna doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (60-80, possibly more, administered expired moderna doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (60-80, possibly more, administered expired moderna doses). In November 2021, EXPIRED PRODUCT ADMINISTERED (60-80, possibly more, administered expired moderna doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The expired doses were administered from 08-NOV-2021 to 22-NOV-2021 It was reported that the vial didn't undergo any temperature excursions. The reporter reported that on 08-Nov-2021 13 doses, on 09-Nov-2021 5 doses, on 10-Nov-2021 6 doses, on 11-Nov-2021 5 doses, on 12-Nov-2021 5 doses, on 15-Nov-2021 5 doses, on 16-Nov-2021 8 doses, on 17-Nov-2021 5 doses, on 18-Nov-2021 23 doses, on 19-Nov-2021 3 doses, on 22-Nov-2021 3 doses of expired doses were administered. All 81 doses were booster doses.    Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Primary reporter details were added. Suspect drug dose number was added. On 01-Dec-2021: Follow-up was received with list of administration dates and number of dosage given on each day.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Contusion, Loss of consciousness, Nausea
Clinical narrative: Passed out but when she awoke she was no longer in the kitchen; Crawled to bed and stayed there for an hour; Bruised big toe; Started feeling bad nauseous for a moment; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out but when she awoke she was no longer in the kitchen), BED REST (Crawled to bed and stayed there for an hour), CONTUSION (Bruised big toe) and NAUSEA (Started feeling bad nauseous for a moment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076CZ1A, 015M20A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included CALCIUM and CALENDULA OFFICINALIS, GINKGO BILOBA, SOLANUM LYCOPERSICUM, VACCINIUM MYRTILLUS (EYE HEALTH) for Supplementation therapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out but when she awoke she was no longer in the kitchen), BED REST (Crawled to bed and stayed there for an hour), CONTUSION (Bruised big toe) and NAUSEA (Started feeling bad nauseous for a moment). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out but when she awoke she was no longer in the kitchen), BED REST (Crawled to bed and stayed there for an hour), CONTUSION (Bruised big toe) and NAUSEA (Started feeling bad nauseous for a moment) outcome was unknown.            Concomitant medications included Cholesterol medication along with above mentioned medications. No treatment details were reported.   This case was linked to MOD-2021-403391 (Patient Link).
Age: 2.0
Sex: U
Vaccine: UNK
Symptoms: Diphtheria, Respiratory disorder
Clinical narrative: respiratory problems; This is a spontaneous report received from a non-contactable nurse.  A 2 year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) at the age of 2 years as, single dose for immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: Respiratory disorder (non-serious), outcome "unknown", described as "respiratory problems".  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mass, Nasopharyngitis, Pain, Vaccination site pain
Clinical narrative: cold; chills; body aches; my are (arm) was sore at the injection site; I had a not the size of a quarter on my right arm; I had a not the size of a quarter on my right arm / painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 15:45 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Factor V" (unspecified if ongoing); "Knee problems" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NAPROXEN; OMEPRAZOLE; PROPRANOLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM9809, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 04Feb2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 06Nov2021 13:30, outcome "not recovered", described as "cold"; CHILLS (non-serious) with onset 06Nov2021 13:30, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 06Nov2021 13:30, outcome "not recovered", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset 06Nov2021 13:30, outcome "not recovered", described as "my are (arm) was sore at the injection site"; MASS (non-serious) with onset 06Nov2021 13:30, outcome "not recovered", described as "I had a not the size of a quarter on my right arm"; PAIN (non-serious) with onset 06Nov2021 13:30, outcome "not recovered", described as "I had a not the size of a quarter on my right arm / painful". The events "cold", "chills", "body aches", "my are (arm) was sore at the injection site", "i had a not the size of a quarter on my right arm" and "i had a not the size of a quarter on my right arm / painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nasopharyngitis, chills, pain, vaccination site pain, mass, pain.   Additional Information: No Covid prior vaccination, nor tested post vaccination. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her arm was sore and was sore into her head and neck; it was swollen. It is tolerable; her arm was sore and was sore into her head and neck/it is traveling from there up her neck; her arm was sore and was sore into her head and neck/it is traveling from there up her neck; her arm was sore and was sore into her head and neck/it is traveling from there up her neck; huge lump under her arm is about the size of a golf ball, but it is not firm. It is swollen.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 17:40 (Lot number: 30130BA) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "spinal issues" (unspecified if ongoing), notes: lot of spinal issues. Family history included: "Lupus" (unspecified if ongoing), notes: Mom had Lupus. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot: E11042, Caller said that it could be EL1042, Expiration: Unknown), administration date: 11Jan2021, when the patient was 41 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Received: 27Jan2021, Lot: EL3802, Expiry: Unknown), administration date: 27Jan2021, when the patient was 41 years old, for Covid-19 Immunization. The following information was reported: AXILLARY MASS (non-serious) with onset 17Nov2021 10:30, outcome "not recovered", described as "huge lump under her arm is about the size of a golf ball, but it is not firm. It is swollen."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was sore and was sore into her head and neck"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "it was swollen. It is tolerable"; PAIN (non-serious), HEADACHE (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "her arm was sore and was sore into her head and neck/it is traveling from there up her neck".  Additional information: Expiry Date of Covid-19 Vaccine was unknown. Investigation Assessment: No. Family Medical History Relevant to AE(s): Mom has Lupus and they are testing the caller for Lupus and osteoarthritis in her neck. History: She has a lot of spinal issues and did not know if it was from her neck, but said that she thinks it is from her lymph node because it is traveling from there up her neck. Patient thinks she received her first 2 doses in the right arm. Patient woke up with a huge lump under her armpit and it was sore and sore to touch, but not excruciating. She was more concerned about how big it was. Additional Vaccines Administered on Same Date of the Pfizer Suspect None. Adverse events did not require visit to Emergency Room/ Physician Office. Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Relevant Tests: None  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin mass
Clinical narrative: A lot of itchy bumps to left arm especially in the anti-cubital areas; A lot of itchy bumps to left arm especially in the anti-cubital areas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 18:00 (Lot number: ff2589) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gluten intolerance" (unspecified if ongoing). Concomitant medication(s) included: METAMUCIL FIBRECAPS. The following information was reported: PRURITUS (non-serious), SKIN MASS (non-serious) all with onset 16Nov2021 12:00, outcome "not recovered" and all described as "A lot of itchy bumps to left arm especially in the anti-cubital areas". Therapeutic measures were not taken as a result of pruritus, skin mass. No follow-up attempts are possible. No further information is expected.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
Clinical narrative: Lymph nodes swollen on left side of body; same arm where vaccine was received.; Dose Number: 3; offlabel use; Dose 1, brand: Moderna/ Dose 2, brand: Moderna / Dose 3, brand: Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Nov2021 11:30 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Dose Number: 3"; OFF LABEL USE (non-serious) with onset 23Nov2021, outcome "unknown", described as "offlabel use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Nov2021, outcome "unknown", described as "Dose 1, brand: Moderna/ Dose 2, brand: Moderna / Dose 3, brand: Comirnaty"; LYMPHADENOPATHY (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Lymph nodes swollen on left side of body; same arm where vaccine was received.". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: It was reported that the patient had no known allergies. The patient had no covid prior vaccination and not tested for covid post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Incorrect dose administered
Clinical narrative: a little bit more tired yesterday; came in and they kinda forced the Pfizer booster on her couple of days ago.; came in and they kinda forced the Pfizer booster on her couple of days ago.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 100 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 23Nov2021 (Batch/Lot number: unknown) at the age of 100 years as dose 4 (initial pfizer booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date Sep2021 (Batch/Lot number: unknown). Relevant medical history included: "Rapid Heart Rate" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for heart rate. Vaccination history included: Moderna covid-19 vaccine (Dose 1, Lot: 013L20A), administration date: 22Jan2021, when the patient was 99 years old, for Covid-19 immunization; Moderna covid-19 vaccine (Dose 2, Lot: 028L20A), administration date: 18Feb2021, when the patient was 99 years old, for Covid-19 immunization; Moderna covid-19 vaccine (Dose 3, Lot: 058F21A), administration date: 28Oct2021, when the patient was 100 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 23Nov2021, outcome "unknown" and all described as "came in and they kinda forced the Pfizer booster on her couple of days ago."; FATIGUE (non-serious) with onset 25Nov2021, outcome "unknown", described as "a little bit more tired yesterday".  Additional information: the reporter mentioned that the patient has been taking Carvedilol for many decades.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Slight numbness in face and arm on side where shot was given; 1st dose Moderna, 2nd dose Moderna; 1st dose Moderna, 2nd dose Moderna; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 (Lot number: FJ1620) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 037A21B, Location of injection: Arm Right), administration date: 13Apr2021, when the patient was 45 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 031A21A, Location of injection: Arm Right), administration date: 18Mar2021, when the patient was 45 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 28Nov2021, outcome "unknown" and all described as "1st dose Moderna, 2nd dose Moderna"; IMMUNISATION (non-serious) with onset 28Nov2021, outcome "unknown", described as "Booster"; HYPOAESTHESIA (non-serious) with onset 28Nov2021 11:30, outcome "unknown", described as "Slight numbness in face and arm on side where shot was given". It was unknown if therapeutic measures were taken as a result of hypoaesthesia.   Additional information: Follow-up attempts are completed.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Product administered to patient of inappropriate age
Clinical narrative: booster; Pediatric dose (orange cap) was administered to three individuals.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 80 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Pediatric dose (orange cap) was administered to three individuals.". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Illness, Immunisation
Clinical narrative: Illness; inflammation; joint aches; swollen lymph nodes; muscle aches; chills; fever; head aches; Booster; (flu)  vaccine taken together; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral since 01Sep2021 (ongoing) (Batch/Lot number: unknown) at 5 mg 2x/day; influenza vaccine (INFLUENZA VACCINE), administration date Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Nov2021, outcome "unknown", described as "(flu)  vaccine taken together"; ILLNESS (non-serious) with onset 16Nov2021, outcome "recovering", described as "Illness"; INFLAMMATION (non-serious) with onset Nov2021, outcome "recovering", described as "inflammation"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "recovering", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovering", described as "swollen lymph nodes"; MYALGIA (non-serious) with onset Nov2021, outcome "recovering", described as "muscle aches"; CHILLS (non-serious) with onset Nov2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset Nov2021, outcome "recovering", described as "head aches". The action taken for tofacitinib citrate was temporarily withdrawn. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Interchange of vaccine products, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Illness; inflammation; joint aches; swollen lymph nodes; muscle aches; chills; fever; head aches; Booster; (flu)  vaccine taken together; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral since 01Sep2021 (ongoing) (Batch/Lot number: unknown) at 5 mg 2x/day; influenza vaccine (INFLUENZA VACCINE), administration date Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Nov2021, outcome "unknown", described as "(flu)  vaccine taken together"; ILLNESS (non-serious) with onset 16Nov2021, outcome "recovering", described as "Illness"; INFLAMMATION (non-serious) with onset Nov2021, outcome "recovering", described as "inflammation"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "recovering", described as "joint aches"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "recovering", described as "swollen lymph nodes"; MYALGIA (non-serious) with onset Nov2021, outcome "recovering", described as "muscle aches"; CHILLS (non-serious) with onset Nov2021, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset Nov2021, outcome "recovering", described as "head aches". The action taken for tofacitinib citrate was temporarily withdrawn. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: my ear started hurting; almost fell down from being so dizzy; I had the JnJ in Apr2021/ most recent dose details:brand=pfzer booster; booster; I had the JnJ in Apr2021/ most recent dose details:brand=pfzer booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 15:00 (Batch/Lot number: unknown) at the age of 60 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Im never sick. Ive had the flu once in my life at the age of 10" (unspecified if ongoing), notes: Other medical history: Im never sick. Ive had the flu once in my life at the age of 10; "I rarely get colds" (unspecified if ongoing), notes: Other medical history: I rarely get colds. There were no concomitant medications. Vaccination history included: Janssen vaccine (Dose:1, I had the JnJ with no issues), administration date: Apr2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "No issues". The following information was reported: OFF LABEL USE (non-serious) with onset 14Nov2021, outcome "unknown", INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Nov2021 15:00, outcome "unknown" and all described as "I had the JnJ in Apr2021/ most recent dose details: brand=Pfizer booster"; IMMUNISATION (non-serious) with onset 14Nov2021 15:00, outcome "unknown", described as "booster"; EAR PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "my ear started hurting"; DIZZINESS (non-serious) with onset 17Nov2021 02:00, outcome "not recovered", described as "almost fell down from being so dizzy". Therapeutic measures were not taken as a result of ear pain, dizziness.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. and no Known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Mobility decreased, Monoplegia
Clinical narrative: she was paralyzed in her legs; Her husband had to carry her to bathroom throughout the day; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Nov2021 15:00 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: treated by Ocrevus; "COVID virus", start date: Oct2021 (unspecified if ongoing), notes: hospitalized for three days. There were no concomitant medications. The following information was reported: MONOPLEGIA (medically significant) with onset 25Nov2021, outcome "recovering", described as "she was paralyzed in her legs"; MOBILITY DECREASED (non-serious) with onset 25Nov2021, outcome "recovering", described as "Her husband had to carry her to bathroom throughout the day"; GAIT DISTURBANCE (non-serious) with onset 25Nov2021, outcome "recovering", described as "couldn't walk". Therapeutic measures were not taken as a result of monoplegia, mobility decreased, gait disturbance. Clinical course: The second shot she has not got yet, Second shot scheduled on 14Dec2021. She is not sure if she should get the second vaccine, but then that would mean she is not fully vaccinated. She specified her doctor recommended her to get the Moderna COVID 19 vaccines as her second dose. Patient received her first dose last Wednesday at 15:00 and was paralyzed in her leg the next morning. She specified it took hours to take the feeling out and now she can walk.   The lot number for bnt162b2 was not provided and will be requested during follow up.