chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Extra dose administered, Vaccination site pain
Clinical narrative: Shortness of breath; Soreness at injection site; Patient has had 5 Moderna vaccines in total; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), VACCINATION SITE PAIN (Soreness at injection site) and EXTRA DOSE ADMINISTERED (Patient has had 5 Moderna vaccines in total) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient has had 5 Moderna vaccines in total). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved, VACCINATION SITE PAIN (Soreness at injection site) was resolving and EXTRA DOSE ADMINISTERED (Patient has had 5 Moderna vaccines in total) outcome was unknown.      Concomitant medications details were not reported by the reporter.  On an unspecified date patient received first dose, first booster dose and second booster dose of monovalent COVID-19 vaccine moderna and on 13-Mar-2021, patient received the second dose.  Patient reported shortness of breath which started a couple of days ago, Patient did not had all the Lot numbers or dates except for date of second dose and Lot and date for Bivalent Booster. Patient has not sought any medical attention.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine).    This was the first adult patient case out of reported 4 adult patients.  Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 immunisation.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine).    No concomitant medications was reported. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients received Monovalent Booster instead of Bivalent booster of Moderna COVID-19 vaccine).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the fourth patient of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-647518, US-MODERNATX, INC.-MOD-2022-647563, US-MODERNATX, INC.-MOD-2022-647562 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647518:patient 1 US-MODERNATX, INC.-MOD-2022-647563:Patient-3 US-MODERNATX, INC.-MOD-2022-647562:patient 2
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arthralgia, Bedridden, Feeding disorder, Pain in extremity
Clinical narrative: she was sick in bed; could not eat/ could not keep food down; stomach distress; usual soreness in the arm; hurting everywhere (joints); This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: flu shot in 2021. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Childhood asthma (childhood asthma), Bronchitis (bronchitis continuing bouts of bronchitis but the last time she got sick was fall of 2-19 before the pandemic), General anesthesia (nausea and vomiting), Drug allergy (cortisone shot), Allergy to antibiotic (Allergic to doxycycline (severe diarrhea)), Allergy to antibiotic (Allergic to vibramycin), Drug allergy (Allergic to markain (difficult of breathing)) and Adhesive tape allergy (surgical tape).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)). In April 2021, BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)) had resolved.            No concomitant medication was provided.  It was reported that patient had significant side effects and did not vomit and had no diarrhea. These symptoms were lasted fo 4-5 days.    It was reported that the adverse event did not cause patient to seek medical care and the patient did not experienced a similar event in the past.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-647568, MOD-2022-647558 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: she was sick in bed; could not eat/ could not keep food down; stomach distress; usual soreness in the arm; hurting everywhere (joints); This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: flu shot in 2021. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Childhood asthma (childhood asthma), Bronchitis (bronchitis continuing bouts of bronchitis but the last time she got sick was fall of 2-19 before the pandemic), General anesthesia (nausea and vomiting), Drug allergy (cortisone shot), Allergy to antibiotic (Allergic to doxycycline (severe diarrhea)), Allergy to antibiotic (Allergic to vibramycin), Drug allergy (Allergic to markain (difficult of breathing)) and Adhesive tape allergy (surgical tape).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)). In April 2021, BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)) had resolved.            No concomitant medication was provided.  It was reported that patient had significant side effects and did not vomit and had no diarrhea. These symptoms were lasted fo 4-5 days.    It was reported that the adverse event did not cause patient to seek medical care and the patient did not experienced a similar event in the past.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-647568, MOD-2022-647558 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Sweats; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweats) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweats) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported.    No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647578, US-MODERNATX, INC.-MOD-2022-647571 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647578:Case for patient-2 US-MODERNATX, INC.-MOD-2022-647571:Reporter's case
Sex: U
Vaccine: COVID19
Symptoms: Headache, Inflammation, Nasal congestion, Tinnitus
Clinical narrative: congestion; I have inflammation all over; tinnitus; major headaches; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (congestion), INFLAMMATION (I have inflammation all over), TINNITUS (tinnitus) and HEADACHE (major headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), INFLAMMATION (I have inflammation all over), TINNITUS (tinnitus) and HEADACHE (major headaches). At the time of the report, NASAL CONGESTION (congestion), INFLAMMATION (I have inflammation all over), TINNITUS (tinnitus) and HEADACHE (major headaches) outcome was unknown.            No concomitant medication reported.  No treatment was reported however patient seek information for the treatment.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Mother thinks kids received Bivalent booster instead of Monovalent; State's Database shows received vaccine meant for 5M-11-year-old for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (State's Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (State's Database shows received vaccine meant for 5M-11-year-old for booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (State's Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. The age of patient was reported as 12.5-year-old. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647610, US-MODERNATX, INC.-MOD-2022-647577 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647610:mother case US-MODERNATX, INC.-MOD-2022-647577:Boy child case
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent booster from a vial with Red Cap instead of blue cap; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Significant Live Follow up received contains patient age and lot number updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent booster from a vial with Red Cap instead of blue cap; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent booster from a vial with Red Cap instead of blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Sep-2022: Significant Follow up received contains patient age and lot number updated
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient thinks that she received the pediatric 5M-11Y Monovalent vaccine instead of the Bivalent/Patient observed vaccine being drawn from the same vial as patient kids and administered to patient arm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Patient observed the HCP drawing the liquid out of the same vial (1 vial, Moderna COVID-19 vaccine meant for 5M-11-year-old) and administering to patient.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MODERNATX, INC. (E2B Linked Report). Sender's Comments:  MODERNATX, INC:Boy Child case MODERNATX, INC.-MOD: Girl Child case
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Patient felt achy.; sore right arm; minor headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Patient felt achy.), PAIN IN EXTREMITY (sore right arm) and HEADACHE (minor headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Pacemaker insertion (cardiac) (3 pacemaker). Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 vaccine (Dose 1) and Pfizer Covid-19 vaccine (Dose 2). Past adverse reactions to the above products included Adverse reaction with Pfizer Covid-19 vaccine; and No adverse event with Pfizer Covid-19 vaccine. Concurrent medical conditions included Arrhythmia (Cardiac History significant for an ongoing arrythmia and 3 different pacemakers).    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced PAIN (Patient felt achy.), PAIN IN EXTREMITY (sore right arm) and HEADACHE (minor headache). At the time of the report, PAIN (Patient felt achy.), PAIN IN EXTREMITY (sore right arm) and HEADACHE (minor headache) outcome was unknown.            No concomitant medication were provided.  It was reported that the patient initially had a Primary Series of the Pfizer Covid-19 vaccine. The patient had a serious reaction to second dose of the Pfizer vaccine and took the Moderna Covid 1 vaccine for the booster.   No treatment details were provided
Age: 0.75
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Bivalent booster vaccine administered instead of Monovalent booster; Bivalent booster vaccine administered to 9 months old patient instead of Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 9 months old patient instead of Monovalent) and NO ADVERSE EVENT (No adverse event) in a 9-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 9 months old patient instead of Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 9 months old patient instead of Monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Bivalent booster vaccine administered instead of Monovalent booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Bivalent booster vaccine administered to 9 months old patient instead of Monovalent).    No concomitant medication was reported.  Pharmacist reported that 9 months old patient received a Bivalent Moderna COVID-19 vaccine about 1 week ago from the day of reporting instead of the Monovalent booster and stated that all previous doses of COVID-19 vaccine for this patient were Moderna.  Reporter did not remember if it was the patients first booster or 2nd booster.  No treatment information was provided.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Extrasystoles, Lymph node pain, Pain in extremity
Clinical narrative: Heart fluttering; Lymph Nodes in right armpit were sore; Skipped heart beats; Lymph Nodes in right armpit were sore and went into my upper arm; This serious initial spontaneous safety report from RA was received by Novavax on 16-SEP-2022 from a consumer.  A female of 48 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 dose 1 in right deltoid on 25-AUG-2022. The following medical history was reported: Drug hypersensitivity to Codeine and Steroids, Supraventricular tachycardia and Cardiac ablation in MAR-2021. No concomitant medications were reported.  On 26-AUG-2022, 2 days after vaccination, the individual experienced lymph nodes in right armpit were sore (PT: Lymph node pain) and went into my upper arm (PT: Pain in extremity).  On 02-SEP-2022, 9 days after vaccination, the individual experienced heart fluttering (PT: Cardiac flutter) (Serious: Medically Significant) and skipped heart beats (PT: Extrasystoles).  At the time of reporting, the event outcomes of Lymph node pain  and Pain in extremity were recovered/resolved and event stop date was 30-AUG-2022, Cardiac flutter was recovered/resolved and event stop date was 04-SEP-2022, Extrasystoles was recovered/resolved and event stop date was 06-SEP-2022. No additional information was provided.; Sender's Comments: This 48  year-old female experienced: Cardiac flutter, Lymph node pain, Pain in extremity and Extrasystoles after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Cardiac flutter was assessed as serious. The events Lymph node pain, Pain in extremity and Extrasystoles were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events were assessed as Possible.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Immunisation, Off label use, Pulmonary congestion
Clinical narrative: Sinus and lung congestion; Backache; Sinus and lung congestion; Scratchy throat; Sneezing; Mild cough; offlabel; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:00 as dose 5 (booster), single (Lot number: OH9694) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TELMISARTAN; AMLODIPINE; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose number: 1, product: COVID 19, brand: Pfizer, lot number: EL1283, administration date: 16Jan2021, administration time: 08:00 PM, vaccine location: Right arm), administration date: 16Jan2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 2, product: COVID 19, brand: Pfizer, lot number: EL9265, administration date: 15Feb2021, Administration time: 08:30 PM, vaccine location: Left arm), administration date: 15Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 3, product: COVID 19, brand: Pfizer, lot number: FD8448, administration date: 31Aug2021, administration time: 09:30 AM, vaccine location: Right arm), administration date: 31Aug2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 4, product: COVID 19, brand: Pfizer, lot number: FJ1615, administration date: 30Jan2022, administration time: 10:00 AM), administration date: 30Jan2022, when the patient was 74-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 10Sep2022 at 10:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 10Sep2022 at 10:00, outcome "unknown", described as "offlabel"; BACK PAIN (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Backache"; COUGH (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Mild cough"; THROAT IRRITATION (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Scratchy throat"; PULMONARY CONGESTION (medically significant), SINUS CONGESTION (non-serious) all with onset 11Sep2022, outcome "not recovered" and all described as "Sinus and lung congestion"; SNEEZING (non-serious) with onset 11Sep2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pulmonary congestion, back pain, sinus congestion, throat irritation, sneezing, cough. Clinical information: Received other vaccine same date vaccine on 10Sep2022 (dose number: 2 and dose number: 3). Other vaccine in four weeks was no. Other medications in two weeks were daily Vitamin v. No covid prior vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion, Sneezing, Throat irritation
Clinical narrative: Sinus and lung congestion; Backache; Sinus and lung congestion; Scratchy throat; Sneezing; Mild cough; offlabel; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 10:00 as dose 5 (booster), single (Lot number: OH9694) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TELMISARTAN; AMLODIPINE; ROSUVASTATIN. Vaccination history included: BNT162b2 (Dose number: 1, product: COVID 19, brand: Pfizer, lot number: EL1283, administration date: 16Jan2021, administration time: 08:00 PM, vaccine location: Right arm), administration date: 16Jan2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 2, product: COVID 19, brand: Pfizer, lot number: EL9265, administration date: 15Feb2021, Administration time: 08:30 PM, vaccine location: Left arm), administration date: 15Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 3, product: COVID 19, brand: Pfizer, lot number: FD8448, administration date: 31Aug2021, administration time: 09:30 AM, vaccine location: Right arm), administration date: 31Aug2021, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose number: 4, product: COVID 19, brand: Pfizer, lot number: FJ1615, administration date: 30Jan2022, administration time: 10:00 AM), administration date: 30Jan2022, when the patient was 74-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 10Sep2022 at 10:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 10Sep2022 at 10:00, outcome "unknown", described as "offlabel"; BACK PAIN (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Backache"; COUGH (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Mild cough"; THROAT IRRITATION (non-serious) with onset 11Sep2022, outcome "not recovered", described as "Scratchy throat"; PULMONARY CONGESTION (medically significant), SINUS CONGESTION (non-serious) all with onset 11Sep2022, outcome "not recovered" and all described as "Sinus and lung congestion"; SNEEZING (non-serious) with onset 11Sep2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pulmonary congestion, back pain, sinus congestion, throat irritation, sneezing, cough. Clinical information: Received other vaccine same date vaccine on 10Sep2022 (dose number: 2 and dose number: 3). Other vaccine in four weeks was no. Other medications in two weeks were daily Vitamin v. No covid prior vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9265), on 06Mar2021 as dose 2, single (Lot number: EN6205), on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 22Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; LOSARTAN; PAXIL [PAROXETINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Positive, notes: positive with antigen test; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Negative; (unspecified date) Positive, notes: still positive; (02Sep2022) Positive, notes: positive pcr test for Covid 19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medication in 2weeks. Took paxlovid Sept 2-6 upon positive pcr test for Covid 19 Sept 2 Symptoms much improved. 3 negative tests. Symptoms returned worse and rebounded testing positive with antigen test on 11Sep still positive and symptoms starting to improve on 14Sep.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Weight
Clinical narrative: COVID has got her really foggy; COVID has got her really foggy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID has got her really foggy". The patient underwent the following laboratory tests and procedures: Weight: 110 lbs, notes: Caller was 110 pounds; 107 lbs, notes: is now 107 pounds. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (1 Nirmatrelvir and 1 Ritonavir tablets) together by mouth twice a day for 5 days from 09Sep2022 (no stop date provided).  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Nocturia
Clinical narrative: urinating frequently at night; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:30 as dose 4 (booster), single (Lot number: GH9702) at the age of 38 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3 (booster)), administration date: 10Jan2022, when the patient was 38-year-old, for COVID-19 Immunization, reaction: "frequent urination at night"; COVID-19 vaccine (Dose 1, Primary Immunization complete, Manufacturer unknown), for COVID-19 Immunization; COVID-19 vaccine (Dose 2, Primary Immunization complete, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: NOCTURIA (non-serious) with onset 14Sep2022, outcome "unknown", described as "urinating frequently at night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received bivalent booster on 14Sep2022 and soon after started again urinating frequently at night. The patient did not have COVID prior vaccination and did not test for COVID post vaccination. The patient did not receive other vaccine in four weeks. Facility type where vaccine was administered was at doctor's office/urgent care.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201166596 same reporter/patient/product/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: painful rash near her knees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "painful rash near her knees". Additional information: Patient just got her dose of the Pfizer Covid 19 vaccine Bivalent (referred to as the new booster, clarified as the Omicron one) this morning, she reported that right now she was experiencing a painful rash near her knees just above her knee on the inside of her leg. She described that it was only painful when something rubs against it and that anyone can hardly see it. She was asking if this has been a previously reported side effect with the Bivalent vaccine. She asked if this rash has anything to say it about what could happen next to her. She also asked how long it will last.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Thrombosis, Weight
Clinical narrative: blood clots; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 2, single (Lot number: EP7534) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other Conditions: No; "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ENOXAPARIN; LEVOTHYROXINE; LISINOPRIL taken for hypertension; THYROID. Vaccination history included: BNT162b2 (I have got the LOT# and for the first one, it was 27Feb2021 and that was EN6205), administration date: 27Feb2021, when the patient was 73-year-old, for COVID-19 immunization.  The following information was reported: THROMBOSIS (disability, medically significant) with onset 2021, outcome "unknown", described as "blood clots". The patient underwent the following laboratory tests and procedures: Body height: about 5(feet) 4(inches); Weight: about 200 pounds. Therapeutic measures were taken as a result of thrombosis.  Clinical course: Vaccination facility type was a hospital pharmacy. The patient received 2 doses of the Pfizer Covid vaccine a year ago and experienced blood clots. Now she was experiencing a 2nd round with blood clots. She would like to know what information about the abnormal and post-mortem blood clots that she had been reading about. She had a filter put in and while they were doing that she was on the blood thinner, Heparin and then she was off it after the filter was in and then she was given a prescription for Enoxaparin and I was only given 120 milligrams a day because last year when she had the blood clot they gave a TPA and she bled and so they were nervous about giving her more and she was nervous about bleeding. Enoxaparin and she had side effects from it.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event "Thrombosis" and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: diagnosed with cancer; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose- 1, his first primary dosage of Pfizer 1), for Covid-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "diagnosed with cancer". Clinical course: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), >12 years  - 15/15 mcg per dose. HCP(Pharmacist) called regarding a patient who received 3 doses of the Pfizer-BioNTech COVID-19 Vaccine, monovalent gray cap formula. HCP stated that between the 2nd and 3rd Pfizer vaccine doses the patient was diagnosed with cancer. Reporter clarified that patient was diagnosed with cancer after second dose and then third dose was administered. HCP was asking if the patient should receive the Pfizer-BioNTech COVID-19 Vaccine, monovalent gray cap formula or the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula and also if the HCP should check the patient's immunity prior to receiving for his 4th dose. She would like to know which vaccine should the patient get if it's the Monovalent or the Bivalent vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Neoplasm malignant and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Rash, Vaccination site pruritus
Clinical narrative: Slight rash; itchiness at site of injection; Dose number 5; Dose number 5; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 11Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: NORTRIPTYLINE. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 11Sep2022 at 11:00, outcome "unknown" and all described as "Dose number 5"; RASH (non-serious) with onset 15Sep2022 at 23:00, outcome "recovered" (Sep2022), described as "Slight rash"; VACCINATION SITE PRURITUS (non-serious) with onset 15Sep2022 at 23:00, outcome "recovered" (Sep2022), described as "itchiness at site of injection". Therapeutic measures were not taken as a result of rash, vaccination site pruritus. Additional information: No known allergies. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine received in four weeks of vaccination. Patient experienced slight rash, itchiness at site of injection. Area was about 3-4-inch diameter. Lasted no longer than 6 hours and then disappeared. Reporter's seriousness criteria was non-serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.