chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Patient tested positive to COVID-19; a little soreness in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a little soreness in the site of injection) and COVID-19 (Patient tested positive to COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included GERD (Intestinal reflux). Concurrent medical conditions included Seasonal allergy, Diabetes, Cholesterolosis NOS, Asthma (Acute asthma), Drug allergy (diabetic medications) and Drug allergy (cholesterol medications).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (a little soreness in the site of injection). On 14-Sep-2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with AZITHROMYCIN for COVID-19, at an unspecified dose and frequency. On 07-Nov-2021, VACCINATION SITE PAIN (a little soreness in the site of injection) had resolved. On 19-Sep-2022, COVID-19 (Patient tested positive to COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2022, SARS-CoV-2 test: (Positive) Positive. On 19-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient did not take other vaccines within one month prior to Moderna COVID-19 vaccine. Patient stated she was under a lot of regular and concomitant medications which also included diabetic medications and cholesterol medications. It was reported that AE cause patient to seek medical care. Patient does not experienced a similar event in the past.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: could not sleep; large bump where the needle was, 4 inches each way; my entire arm, for about four inches each way, turned red; Very scathing pain, unbearable; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (could not sleep), VACCINATION SITE MASS (large bump where the needle was, 4 inches each way), VACCINATION SITE ERYTHEMA (my entire arm, for about four inches each way, turned red) and VACCINATION SITE PAIN (Very scathing pain, unbearable) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer (The patient had all vaccines of Pfizer before Moderna and never had any issue.). Past adverse reactions to the above products included No adverse event with Pfizer.   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 INSOMNIA (could not sleep), VACCINATION SITE MASS (large bump where the needle was, 4 inches each way), VACCINATION SITE ERYTHEMA (my entire arm, for about four inches each way, turned red) and VACCINATION SITE PAIN (Very scathing pain, unbearable). At the time of the report, INSOMNIA (could not sleep), VACCINATION SITE MASS (large bump where the needle was, 4 inches each way), VACCINATION SITE ERYTHEMA (my entire arm, for about four inches each way, turned red) and VACCINATION SITE PAIN (Very scathing pain, unbearable) had not resolved.     The concomitant medication was not reported. It was reported that, since the sixth day of administrating of Moderna booster vaccine, the patient had a large bump where the needle was inserted with the entire arm, for about four inches each way, turned red. The patient had unbearable scathing pain and could not sleep. Events had been going on. It was only moderately better. It was not only for 24, 48, 72 hours. The events were going on for five days. Treatment medication was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender 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 02-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose). No concomitant drug was reported. Reporter stated that a patient came over to receive the second dose in the primary series, but they realized that the first dose was a Bivalent Booster dose. No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: body aches; chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (body aches) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-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 30-Sep-2022, the patient experienced MYALGIA (body aches) and CHILLS (chills). At the time of the report, MYALGIA (body aches) and CHILLS (chills) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient received bivalent Moderna booster. The events had resolved within 24 hrs of onset.  No treatment information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Cannot put his arm behind his back; Severe muscle pain for 4 months; Injection administered on biceps muscle; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot put his arm behind his back), VACCINATION SITE PAIN (Severe muscle pain for 4 months) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection administered on biceps muscle) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot put his arm behind his back), VACCINATION SITE PAIN (Severe muscle pain for 4 months) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection administered on biceps muscle). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot put his arm behind his back) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection administered on biceps muscle) outcome was unknown and VACCINATION SITE PAIN (Severe muscle pain for 4 months) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects). At the time of the report, IMMUNISATION REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported that they had very little side effects with previous Moderna vaccines.  No treatment medications were reported.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Fatigue, Limb discomfort, SARS-CoV-2 test
Clinical narrative: symptoms like allergies; tired; arms were heavy; chills; This spontaneous case was reported by a physician and describes the occurrence of LIMB DISCOMFORT (arms were heavy), CHILLS (chills), ALLERGY TO VACCINE (symptoms like allergies) and FATIGUE (tired) in a 56-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 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII), DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), LOSARTAN POTASSIUM (LOSARTIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), MULTIVITAMIN IRON and PROBIOTICS NOS for an unknown indication.    On 25-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Sep-2022, the patient experienced LIMB DISCOMFORT (arms were heavy) and CHILLS (chills). On 01-Oct-2022, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced ALLERGY TO VACCINE (symptoms like allergies). The patient was treated with IBUPROFEN on 26-Sep-2022 at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (arms were heavy), CHILLS (chills), ALLERGY TO VACCINE (symptoms like allergies) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2022, SARS-CoV-2 test: (Positive) Positive.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had bivalent booster dose. It was reported that patient had also experienced chills with some of her previous Moderna vaccines.   This case was linked to US-MODERNATX, INC.-MOD-2022-654635 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654635:bivalent booster
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tired; Arm hurt; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired) and VACCINATION SITE PAIN (Arm hurt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-CA) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 1) and Pfizer vaccine (Dose 3). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2022, the patient experienced FATIGUE (Tired) and VACCINATION SITE PAIN (Arm hurt). At the time of the report, FATIGUE (Tired) and VACCINATION SITE PAIN (Arm hurt) outcome was unknown.            No concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2022-654638 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included DILTIAZEM (CARDIZEM [DILTIAZEM]), LOSARTAN POTASSIUM (LOSARTIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), MULTIVITAMIN IRON and PROBIOTICS NOS for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654636 (E2B Linked Report). This case was linked to MOD-2022-654626 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654636:Other patient case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received a 3rd Monovalent Booster instead of a Bivalent Booster dose; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a 3rd Monovalent Booster instead of a Bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a 3rd Monovalent Booster instead of a Bivalent Booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a 3rd Monovalent Booster instead of a Bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No concomitant medications were reported.  Patient went to the pharmacy to receive the new Bivalent Booster, but the pharmacist gave him the Monovalent Booster instead. Patient received primary series and 3rd monovalent booster vaccines and experienced no side effects.  No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: pain in the arm; mild headache; low fever of 99 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no medical history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Glaucoma and Seasonal allergy (season allergies). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, CALCIUM and PRAVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F). On 27-Feb-2021, PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications also included medications for allergies.  It was reported that patient received first dose of Moderna COVID-19 Vaccine on 25 Feb 2021 and second  dose on 25 Mar 2021.   On 25-Mar-2021, the patient again experienced mild headache, pain in the arm and low fever of 99 degree F.  On 27-Mar-2021, the patient recovered from the events.  No treatment medications were provided.   This case was linked to MOD-2022-654644 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Headache, Pain in extremity, Pyrexia
Clinical narrative: patient got COVID-19 during a week or so; pain in the arm; mild headache; low fever of 99 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache), PYREXIA (low fever of 99 degree F) and COVID-19 (patient got COVID-19 during a week or so) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy (season allergies) and Glaucoma. Concomitant products included CALCIUM and PRAVASTATIN for an unknown indication.    On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F). In August 2022, the patient experienced COVID-19 (patient got COVID-19 during a week or so). The patient was treated with IBUPROFEN for COVID-19, at an unspecified dose and frequency. On 27-Nov-2021, PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) had resolved. In September 2022, COVID-19 (patient got COVID-19 during a week or so) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: low fever of 99 degree F. In August 2022, SARS-CoV-2 test: (Positive) Positive.         Patient did not have any medical history relating to mentioned AE and both Acute and had no chronic illnesses at the time of vaccination. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concomitant medication included Medications for allergies, eye drops for glaucoma.  Patient called doctor. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-654642 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: patient got COVID-19 during a week or so; pain in the arm; mild headache; low fever of 99 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache), PYREXIA (low fever of 99 degree F) and COVID-19 (patient got COVID-19 during a week or so) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy (season allergies) and Glaucoma. Concomitant products included CALCIUM and PRAVASTATIN for an unknown indication.    On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F). In August 2022, the patient experienced COVID-19 (patient got COVID-19 during a week or so). The patient was treated with IBUPROFEN for COVID-19, at an unspecified dose and frequency. On 27-Nov-2021, PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) had resolved. In September 2022, COVID-19 (patient got COVID-19 during a week or so) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: low fever of 99 degree F. In August 2022, SARS-CoV-2 test: (Positive) Positive.         Patient did not have any medical history relating to mentioned AE and both Acute and had no chronic illnesses at the time of vaccination. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concomitant medication included Medications for allergies, eye drops for glaucoma.  Patient called doctor. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-654642 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient) 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 assessment was provided for INCORRECT DOSE ADMINISTERED (We had someone give a bivalent 0.5mL dose instead of a primary dose to a patient).    No concomitant medications were reported. No treatment medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ear infection, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.; ear infection/ear drainage; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.) and EAR INFECTION (ear infection/ear drainage) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     The patient's past medical history included Atrial septal defect, Subvalvular aortic stenosis, Open heart surgery (Hole in heart) and Open heart surgery (Sub aortic stenosis). Concurrent medical conditions included Down's syndrome.    On 29-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 02-Oct-2022, the patient experienced COVID-19 (Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.) and EAR INFECTION (ear infection/ear drainage). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.) and EAR INFECTION (ear infection/ear drainage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant drug information was provided. Patient had experienced the symptoms of cold, cough and lots of nasal congestion and ear drainage. Treatment medications included medicines for an ear infection.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.; sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 027B21A) for COVID-19 prophylaxis.     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 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PRURITUS (itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.) and PAIN IN EXTREMITY (sore arm). At the time of the report, VACCINATION SITE PRURITUS (itch/Following the 3rd one the itch in her arm came back after it had gone away and itched some more.) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medication information provided. Patient age was 63 years 8 months. No treatment information provided.   This case was linked to MOD-2022-654750 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; Received Expired first primary dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No Adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received Expired first primary dose of Moderna COVID-19 Vaccine).    No concomitant medications were reported. The vial was stored in an unbroken carton in the refrigerator. Vial size was reported as 5.5 mL. The vial was initially stored in the refrigerator on 01-Sep-2022. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Had a bout of vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Had a bout of vertigo) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 011F21A, 030A21A and 039K20A) for COVID-19 prophylaxis.     The patient never had COVID positive test or diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Toradol) and Blood pressure high (controlled by medication.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Had a bout of vertigo). At the time of the report, VERTIGO (Had a bout of vertigo) outcome was unknown.      No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-654745 (Patient Link).
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General symptom
Clinical narrative: Pt started with redness in cheeks and forhead.  After about 10 min developed hives on cheeks. Itchy.  After about 20 min hives started to go away. After 30 min, hives and redness gone
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Pt started with redness in cheeks and forhead.  After about 10 min developed hives on cheeks. Itchy.  After about 20 min hives started to go away. After 30 min, hives and redness gone
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure high output, Cardiac stress test, Heart rate, Inflammation, Tachycardia
Clinical narrative: tachycardia, up to the high 150's; carotid body syndrome caused by inflammation in carotid body; The initial case was missing the following minimum criteria: other-Info not qualifying for AE. Upon receipt of follow-up information on (15Sep2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A patient (no qualifiers provided) 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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: TACHYCARDIA (hospitalization), outcome "unknown", described as "tachycardia, up to the high 150's"; INFLAMMATION (hospitalization), outcome "unknown", described as "carotid body syndrome caused by inflammation in carotid body". The patient underwent the following laboratory tests and procedures: Cardiac failure high output: high, notes: cardiac work up; Cardiac stress test: Unknown results; Heart rate: 150s, notes: Increased/tachycardia, up to the high 150's. Additional information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than equal 12 years-15/15 mcg per dose. With the initial vaccine this did not happen. With the booster, tachycardia, up to the high 150's, patient had to be hospitalized. Patient had a cardiac work up, stress test. Diagnosed as carotid body syndrome caused by inflammation in carotid body. Patient was on beta blockers for 6 months after the dose. Gave Moderna booster at half dose. Cardiologist recommended to give it again, but it happened again.Reporter inquired whether Carotid body syndrome with tachycardia required beta-blocker treatment after Moderna vaccine, and if there is less chance of tachycardia, heart rates in the 150s with the Pfizer vaccine. 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.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported events and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: By mistake Covid- 19 Moderna (Booster Dose Only, Lot: AR6965B, Exp: 11/25/22) was administered to patient instead of Covid-19 Updated Booster (Bivalent). Patient was reached and notified about incidence; she was asked if she had experienced any side effect. She reported not suffering from any adverse event.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: By mistake patient was administered with Covid- 19 Vaccine (Booster Dose Only, Lot: AR6965B, Exp: 11/25/22) instead of Covid- Updated Booster (Bivalent). Patient was contacted and notified about incident. She indicated that she has NOT suffered from any type of side effect.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: My left arm where I had the shot was  itchy, a little swollen and hard for 3 days now..I put  a cortisone ointment for itchiness and I take Benadryl.  It was the same side effects with my other previous shots.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Acupuncture, Arthralgia, Autoimmune disorder, Balance disorder, Biopsy skin abnormal
Clinical narrative: symptoms started with loosing sensation in feet/legs then charlie horses at night in calves, continued to loss of sensation, tingling and burning in feet traveling up legs then to hands arms, exhaustion, bubbling excema like outbreaks on hands that don't go away, other inflammatory/auto immune type symptons like joint pain, muscle pain, loss of flexibility, difficulty with balance at times, sleep disturbances  - have been on hydroxychloroquine, gabapentin and prednisone, multiple supplements, anti inflammatory diet, acupuncture - all medical records can be shared
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Eczema, Inflammation, Laboratory test abnormal
Clinical narrative: symptoms started with loosing sensation in feet/legs then charlie horses at night in calves, continued to loss of sensation, tingling and burning in feet traveling up legs then to hands arms, exhaustion, bubbling excema like outbreaks on hands that don't go away, other inflammatory/auto immune type symptons like joint pain, muscle pain, loss of flexibility, difficulty with balance at times, sleep disturbances  - have been on hydroxychloroquine, gabapentin and prednisone, multiple supplements, anti inflammatory diet, acupuncture - all medical records can be shared
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nerve stimulation test
Clinical narrative: symptoms started with loosing sensation in feet/legs then charlie horses at night in calves, continued to loss of sensation, tingling and burning in feet traveling up legs then to hands arms, exhaustion, bubbling excema like outbreaks on hands that don't go away, other inflammatory/auto immune type symptons like joint pain, muscle pain, loss of flexibility, difficulty with balance at times, sleep disturbances  - have been on hydroxychloroquine, gabapentin and prednisone, multiple supplements, anti inflammatory diet, acupuncture - all medical records can be shared
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory loss, Sleep disorder, Small fibre neuropathy
Clinical narrative: symptoms started with loosing sensation in feet/legs then charlie horses at night in calves, continued to loss of sensation, tingling and burning in feet traveling up legs then to hands arms, exhaustion, bubbling excema like outbreaks on hands that don't go away, other inflammatory/auto immune type symptons like joint pain, muscle pain, loss of flexibility, difficulty with balance at times, sleep disturbances  - have been on hydroxychloroquine, gabapentin and prednisone, multiple supplements, anti inflammatory diet, acupuncture - all medical records can be shared
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; mild fever; This is a spontaneous report received from a contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), 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, SINGLE), for COVID-19 immunization, reaction(s): "Chills", "Mild fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Chills", "Mild fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "mild fever".  Additional information: Patient reported mild fever and chills for less than 24 hours after bivalent. Symptoms were less than with initial COVID-19 vaccine and previous booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Muscle disorder, Muscular weakness
Clinical narrative: His shoulder is weaker on the left side/knees were not good; after taking the vaccine his lifting capacity dropped by 50% and the caller called it useless arm syndrome; knot of muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ARTHROPATHY (non-serious), outcome "unknown", described as "His shoulder is weaker on the left side/knees were not good"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "after taking the vaccine his lifting capacity dropped by 50% and the caller called it useless arm syndrome"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "knot of muscle".  Additional information: The patient reported that after taking the vaccine his lifting capacity dropped by 50% and the caller called it useless arm syndrome and relayed this has happened every single time after getting the shot. The patient stated it was roughly 30-50%, it's not always the same percent, give or take, it could have been 28%.  Stated the agent kept repeating the same thing over and over saying we will take his information and tell him what to do next.  States he is an intelligent and self-sufficient 40 year-old-male and didn't need to be told twice.  States it dropped by 33-50% and his shoulder had to take over the lifting because his muscles don't respond.  His shoulder is weaker on the left side and he doesn't want to be told to take it easy, he doesn't need someone to think for him. He reported to VAERS and the CDC as well and none has been useful, they are not able to say anything. To be fair, he looked at VAERS and didn't even know it existed, he had never heard of it, and there is around 50,000 pages just on Pfizer alone about side effects and each page has 20-30 results.  Useless arm syndrome is what he called it, it was not an official term. His was so low that like at the time 2000 people had it, that is almost no one out of millions. More had sore arms and he didn't, he had a knot of muscle that wasn't sore, it didn't relax. It wanted to work and was half dollar size, what's going on and if takes a muscle relaxant it affects the whole body.  His arm lifting capacity was lower. He was lifting weights every 3-4 days; he is 6 foot 3 and 250ish pounds and needed to lift his own body mass. His knees are not good anyways. He was not just targeting Pfizer. It was bigger companies that with his questions they were useless. Called about a hoodie, he was light sensitive, hated light. The couldn't answer his questions.   Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Incorrect dose administered, Laboratory test, SARS-CoV-2 test
Clinical narrative: Chest pain; inappropriate dose of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9693) and on 21Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH9693) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Other medical history: Diabetes type 2; "Psoriatic arthritis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ATENOLOL; FOSAMAX. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 21Sep2022, outcome "unknown", described as "inappropriate dose of vaccine administered"; CHEST PAIN (non-serious) with onset 23Sep2022 at 07:00, outcome "recovering". The event "chest pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain.  Additional information; Patient was not taken other vaccine in four weeks. Patient had no covid prior vaccination. Patient had covid tested post vaccination. Chest pain on right side two days post vaccination and laster about 24 hours went to emergency room .
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID.; Tested positive for COVID.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 63-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive for COVID.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive for COVID.  Clinical Course: It was reported that: etransmitting possible duplicate AE details as call was transferred agent, Caller was pharmacist and states "I have a 63-year-old female patient that I am trying to prescribe Paxlovid for, but she already had it in May2022. She got her COVID booster (from unknown manufacturer) on Monday and tested positive for COVID on Tuesday. Do you have any information on retreatment with Paxlovid. Upon follow up on 29Sep2022 it was reported, Pharmacist calling because she has a patient, she is trying to prescribe Paxlovid for. Patient already had Paxlovid back in May2022 and had a COVID vaccine on Monday and tested positive for COVID on Tuesday. Cannot confirm vaccine manufacturer at this time. Verified above information with caller. Declines to complete report. Has patients she needs to call. No report related to a study or programme. Product complaint to report was Yes. Description of Product Complaint: Description of complaint: Had a COVID vaccine on Monday and tested positive for COVID on Tuesday. Product strength and count size dispensed: not provided. Additional lot numbers: not provided. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: Not provided.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events 'Drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: other medical history: Htn; "Known allergy: Latex" (unspecified if ongoing), notes: Known allergy: Latex. Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received the anti-viral treatment details, brand: Paxlovid, treatment started date on 10Sep2022, treatment end on 15Sep2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events COVID-19, DRUG INEFFECTIVE and the suspect drug cannot be excluded. The case will be reassessed once new information is available.