chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash with small bumps flaring up all over body (not at injection site). Taking antihistamine which helps keep it down. Has not gone away yet.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Eye oedema, Urticaria
Clinical narrative: 15 minutes post administration patient experienced localized urticaria and mild edema on the right eye/orbital area. Patient had no SOB or breathing issues.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Echocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Intensive care
Clinical narrative: required holter monitoring and icu admission for heart and neuro adverse reactions
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: required holter monitoring and icu admission for heart and neuro adverse reactions
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain, Pain in extremity
Clinical narrative: Instant pain and throbbing of whole arm that lasted two days. Extreme body weakness and dizziness for a week.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Pulmonary embolism
Clinical narrative: Per patient, Janssen vaccine received 2 days prior to presenting to the ER on 5/11/2021 for 1 day of SOB and CP.  This was diagnosed as pulmonary embolism at the ER.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 808C21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.            Patient had no concomitant medications but states he was crippled. He has taken no medications for his side effects.   This case was linked to MOD-2021-400055, MOD-2021-400030 (Patient Link).
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: My fingers don't feel like they have strength; weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,; arm hurts when he lifts it straight up, arm flops around; wooziness; arm irritation, could not even write the case number down; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,), PAIN IN EXTREMITY (arm hurts when he lifts it straight up, arm flops around), DIZZINESS (wooziness), LIMB DISCOMFORT (arm irritation, could not even write the case number down) and ASTHENIA (My fingers don't feel like they have strength) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Aneurysm, Pacemaker syndrome, Heart disorder and Platelet rich plasma therapy (Platelet therapy for his right knee- 2 weeks before booster).    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,), PAIN IN EXTREMITY (arm hurts when he lifts it straight up, arm flops around), DIZZINESS (wooziness) and LIMB DISCOMFORT (arm irritation, could not even write the case number down). On 30-Nov-2021, the patient experienced ASTHENIA (My fingers don't feel like they have strength). At the time of the report, MUSCULAR WEAKNESS (weakness in the right arm and fingers, fingers feel extremely weak, fingers are not working right,), PAIN IN EXTREMITY (arm hurts when he lifts it straight up, arm flops around), DIZZINESS (wooziness), LIMB DISCOMFORT (arm irritation, could not even write the case number down) and ASTHENIA (My fingers don't feel like they have strength) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: Sick every 20 minutes; severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick every 20 minutes) and NAUSEA (severe nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 02DB21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021 at 5:00 PM, the patient experienced ILLNESS (Sick every 20 minutes) and NAUSEA (severe nausea). At the time of the report, ILLNESS (Sick every 20 minutes) and NAUSEA (severe nausea) outcome was unknown.            It was reported that the patient drank lot of water prior to the vaccine.  Patient was not able to take medication hence drank ginger tea.  Concomitant medication reported included blood pressure medication.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received contains start date of first dose and second dose, batch number, start date of event, patient details (age) and concomitant medication of the patient.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product contamination physical
Clinical narrative: Patients received vaccine with silver metal particles; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 015M20A and 015M20A) 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 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 30-Nov-2021, PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains patient details and vaccine information
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 008C21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure abnormal, RIVAROXABAN (XARELTO OD) for Clotting disorder.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-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 (arm was really sore). At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown.            Patient medical condition knee disorder. Patient had a knee replacement surgery on 07 Nov 2021.   This case was linked to MOD-2021-403388 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Eye is red/half eye is red/Eye is blood shot red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eye is red/half eye is red/Eye is blood shot red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 020B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Eye is red/half eye is red/Eye is blood shot red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (Eye is red/half eye is red/Eye is blood shot red) outcome was unknown.            Concomitant product use was not provided by the reporter. Off branded Zyrtec by pharmacy took last night as treatment along with Flonase.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Sore throat; Glands were swollen; Looked uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Looked uncomfortable), OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Glands were swollen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced DISCOMFORT (Looked uncomfortable). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Glands were swollen). At the time of the report, DISCOMFORT (Looked uncomfortable) had not resolved and OROPHARYNGEAL PAIN (Sore throat) and LYMPHADENOPATHY (Glands were swollen) outcome was unknown.            No concomitant medications were reported.   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) 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.   Caller states expired Moderna vaccine was given to patients and wants to know what to do. Five patients received vaccine on 2dec2021 from lot 009c21a. Published expiry date is 15oct2021. Please see attached document for patient identifiers.  No concomitant medications was reported. No treatment drug details was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Breast swelling, Illness, Migraine, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (They have been in bed and), MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/) and BREAST SWELLING (right breast is swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced BEDRIDDEN (They have been in bed and), PAIN IN EXTREMITY (arm pain), PYREXIA (103°F fever) and MYALGIA (large muscle pain). 30-Nov-2021, the patient experienced MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/), BREAST SWELLING (right breast is swollen), ILLNESS (felt sick  instantaneously / have been in bed/unable to function) and VACCINATION SITE LYMPHADENOPATHY (right arm lymph nodes are hugely swollen). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (They have been in bed and), MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/), BREAST SWELLING (right breast is swollen), ILLNESS (felt sick  instantaneously / have been in bed/unable to function), PAIN IN EXTREMITY (arm pain), PYREXIA (103°F fever), VACCINATION SITE LYMPHADENOPATHY (right arm lymph nodes are hugely swollen) and MYALGIA (large muscle pain) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-404048 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia, Vaccination site lymphadenopathy, Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (They have been in bed and), MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/) and BREAST SWELLING (right breast is swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced BEDRIDDEN (They have been in bed and), PAIN IN EXTREMITY (arm pain), PYREXIA (103°F fever) and MYALGIA (large muscle pain). 30-Nov-2021, the patient experienced MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/), BREAST SWELLING (right breast is swollen), ILLNESS (felt sick  instantaneously / have been in bed/unable to function) and VACCINATION SITE LYMPHADENOPATHY (right arm lymph nodes are hugely swollen). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (They have been in bed and), MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/), BREAST SWELLING (right breast is swollen), ILLNESS (felt sick  instantaneously / have been in bed/unable to function), PAIN IN EXTREMITY (arm pain), PYREXIA (103°F fever), VACCINATION SITE LYMPHADENOPATHY (right arm lymph nodes are hugely swollen) and MYALGIA (large muscle pain) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-404048 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: Inappropriate schedule of vaccine administered (1 Dose- 30Mar2021/ 2 Dose- 02Jun2021); rash on her abdomen, both side of sternum, which looked like hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash on her abdomen, both side of sternum, which looked like hives) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (1 Dose- 30Mar2021/ 2 Dose- 02Jun2021)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (1 Dose- 30Mar2021/ 2 Dose- 02Jun2021)). On an unknown date, the patient experienced URTICARIA (rash on her abdomen, both side of sternum, which looked like hives). On 02-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (1 Dose- 30Mar2021/ 2 Dose- 02Jun2021)) had resolved. At the time of the report, URTICARIA (rash on her abdomen, both side of sternum, which looked like hives) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-403687, MOD-2021-404966 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Illness, Influenza like illness
Clinical narrative: like having the flu but 3 times worse; pretty sick; 3 times worse in May or June after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like having the flu but 3 times worse), ILLNESS (pretty sick) and CONDITION AGGRAVATED (3 times worse in May or June after receiving the vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like having the flu but 3 times worse), ILLNESS (pretty sick) and CONDITION AGGRAVATED (3 times worse in May or June after receiving the vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (like having the flu but 3 times worse), ILLNESS (pretty sick) and CONDITION AGGRAVATED (3 times worse in May or June after receiving the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Patient was given a z-pack for his illness.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Maternal exposure during pregnancy
Clinical narrative: swollen limph node in the left side of the neck; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen limph node in the left side of the neck) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 30-Nov-2021, the patient experienced LYMPHADENOPATHY (swollen limph node in the left side of the neck). At the time of the report, LYMPHADENOPATHY (swollen limph node in the left side of the neck) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.            No concomitant and treatment medications were reported
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Magnetic resonance imaging
Clinical narrative: double vision / woke up with double vision; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision / woke up with double vision) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 25-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced DIPLOPIA (double vision / woke up with double vision). At the time of the report, DIPLOPIA (double vision / woke up with double vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: normal (normal) Normal. In November 2021, Magnetic resonance imaging: normal (normal) Normal. 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 product reported by reporter. No treatment medication reported by reporter. Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Added reporter information. Added patient information. Added lab data information. Added product details. Added onset date and outcome of event.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. The facility had a 20 minutes excursion in the freezer that their Moderna Covid -19 vials were stored in. The excursion was on Sunday and the HCP was not told it until today.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Full blood count, Investigation, Madarosis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (004756). The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EK4176) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: Dec2020, when the patient was 51 years old, for COVID-19 immunization.The following information was reported: ALOPECIA AREATA (non-serious) with onset Mar2021, outcome "not recovered", described as "Alopecia areata"; ALOPECIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Alopecia"; MADAROSIS (non-serious), outcome "unknown", described as "She has lost all her hair including her eye brows and eye lashes"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in the arm". The events "alopecia areata", "alopecia" and "she has lost all her hair including her eye brows and eye lashes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata, alopecia.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (004756). The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EK4176) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: Dec2020, when the patient was 51 years old, for COVID-19 immunization.The following information was reported: ALOPECIA AREATA (non-serious) with onset Mar2021, outcome "not recovered", described as "Alopecia areata"; ALOPECIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Alopecia"; MADAROSIS (non-serious), outcome "unknown", described as "She has lost all her hair including her eye brows and eye lashes"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in the arm". The events "alopecia areata", "alopecia" and "she has lost all her hair including her eye brows and eye lashes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata, alopecia.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: 3 days after the vaccination, the patient was hospitalized in intensive unit with respiratory device.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 19:00 (Lot number: FK5127) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Down Syndrome" (unspecified if ongoing). There were no concomitant medications. No known allergies. The following information was reported: RESPIRATORY DISORDER (hospitalization, life threatening) with onset 22Nov2021 12:00, outcome "not recovered", described as "3 days after the vaccination, the patient was hospitalized in intensive unit with respiratory device.". The event "3 days after the vaccination, the patient was hospitalized in intensive unit with respiratory device." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of respiratory disorder included: Bronchodilator, antibiotics, and respiratory therapy. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Myxofibrosarcoma, Pain, Skin mass
Clinical narrative: 2nd dose was minor aches & pains. By end of August 2021 began seeing small growth on shin, rapidly growing
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Pain in extremity, Palpitations, Stress at work
Clinical narrative: palpitations; left arm had been hurting; chest tightness; after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), PAIN IN EXTREMITY (left arm had been hurting), CHEST DISCOMFORT (chest tightness), STRESS AT WORK (after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before) and FATIGUE (fatigue) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (palpitations), PAIN IN EXTREMITY (left arm had been hurting), CHEST DISCOMFORT (chest tightness), STRESS AT WORK (after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before) and FATIGUE (fatigue). At the time of the report, PALPITATIONS (palpitations), PAIN IN EXTREMITY (left arm had been hurting), CHEST DISCOMFORT (chest tightness), STRESS AT WORK (after receiving the vaccine things were stressful at work/I don't feel like I can do as much as I could do before) and FATIGUE (fatigue) had not 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.   No concomitant medication was reported.  It was reported couple days after receiving the vaccine things were stressful at work and he started to experience palpitations, his left arm had been hurting, he had chest tightness, and fatigue. This has continued until today, and he doesn't feel like he can do as much as he could before.   Patient did not receive the 2nd dose because of the possible correlation. He has not taken any medications or treatments for his symptoms, but has been trying to rest. He has never been diagnosed with covid-19, myocarditis, or pericarditis previously.   This case was linked to MOD-2021-404469 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Non significant follow up received contain other patients events.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; ROTATEQ was administered to patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 29-OCT-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, lot # 1742081, expiration date 18-JUL-2022 (exact dose, route of administration, anatomical location were not reported) for prophylaxis.  Administered dose of vaccine has been stored in the temperature of 35.0 degrees Fahrenheit (°F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There were no previous temperature excursions reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA001754: US-009507513-2112USA001753: US-009507513-2112USA001755:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; temperature excursion/vaccines were administered; This spontaneous report as received from a registered nurse refers to a 10-week-old female patient. No information was provided regarding the patient's concomitant medications, pertinent medical history or drug reactions and allergies. On 11-OCT-2021, temperature excursion occurred. Affected vaccines experienced temperature excursion of 9.7 degrees Celsius for one hour. There was no previous temperature excursion reported. On 29-OCT-2021, the patient was vaccinated with the the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose not reported; lot # T026961, expiration date 02-APR-2023) intramuscularly, in the left vastus lateralis (LVL) for prophylaxis, and the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (exact dose not reported; lot# T003011, expiration date 26-NOV-2021), orally. Both vaccines experienced temperature excursion on 11-OCT-2021 (Product storage error). Concomitantly, the patient was vaccinated with the first dose of pneumococcal vaccine conj 7v (crm197) (PREVNAR) and the first dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX). No adverse events were reported.
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; temperature excursion/products were administered; This spontaneous report was received from a medicall assistant and refers to a 9-week-old female patient. Concurrent conditions icluded growth restrictions (birth weight 2.49 kg) and flattening of the skull from positioning. Historical vaccines included hepatitis B vaccine (manufacturer unknown).   On 17-NOV-2021, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707459, expiration date 27-MAR-2022, 2 milliliter, orally for prophylaxis and improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T042012, expiration date 22-JUL-2023 for prophylaxis. Also on that day, the patient was vaccinated tetanus vaccine toxoid (PEDIARIX) lot # 9X3T5, expiration date 05-MAR-2023 and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) lot # EJ4558, expiration date 01-JUL-2023. There were no adverse reaction.  On 16-NOV-2021, the temperature excursion was 62 degrees Fahrenheit, for a time frame of 12 hours. There was no previous temperature excursion.; Sender's Comments:  US-009507513-2111USA008845:
Age: 6.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE was reported by patient; patient received a dose of GARDASIL at age 6; This spontaneous report was received from a registered nurse and refers to a 6-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-JAN-2015, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vial, 0.5 ml, lot # K008931, expiry date 04-MAR-2017 (route and anatomical location of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). The reporter stated that no additional adverse event was reported by the patient (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000819: US-009507513-2112USA000818: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000819: US-009507513-2112USA000825: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000818: US-009507513-2112USA000713: US-009507513-2112USA000820.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000819: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825: US-009507513-2112USA000713.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000818: US-009507513-2112USA000713: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000713: US-009507513-2112USA000819: US-009507513-2112USA000818: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000819: US-009507513-2112USA000820: US-009507513-2112USA000817: US-009507513-2112USA000713: US-009507513-2112USA000818: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Caller reported that VAQTA and ROTATEQ that underwent temperature excursions; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA000819: US-009507513-2112USA000713: US-009507513-2112USA000817: US-009507513-2112USA000821: US-009507513-2112USA000820: US-009507513-2112USA000818: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000818: US-009507513-2112USA000713: US-009507513-2112USA000819: US-009507513-2112USA000821: US-009507513-2112USA000820: US-009507513-2112USA000822: US-009507513-2112USA000824: US-009507513-2112USA000825.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Caller reported that VAQTA and ROTATEQ that underwent temperature excursions; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-NOV-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, lot # 1821791, expiration date 26-JUL-2022 (dose and anatomical location were not reported) for prophylaxis. Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000818: US-009507513-2112USA000819: US-009507513-2112USA000713: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000825:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Caller reported that VAQTA and ROTATEQ that underwent temperature excursions; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-NOV-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, lot # 1821791, expiration date 26-JUL-2022 (dose and anatomical location were not reported) for prophylaxis. Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA000823: US-009507513-2112USA000818: US-009507513-2112USA000824: US-009507513-2112USA000713: US-009507513-2112USA000822: US-009507513-2112USA000820: US-009507513-2112USA000817: US-009507513-2112USA000819: US-009507513-2112USA000821: