chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Long-term tinnitus, left ear. Began December 22, 2021 --  unsuccessfully attempted to treat with oral steroid, klonopin, gingko biloba, and over the counter Lipo Flavonoid.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: During a vaccine clinic, a 10-year-old girl was inadvertently given a 2nd dose of Pfizer for ages 12+ when she should have received the dose for 5 to 11 years old.  Patient was observed for the required 15 min post vaccination; no adverse events observed.
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Joint swelling, Peripheral swelling, Pruritus, Rash, Swelling face
Clinical narrative: Bumps on the skin, itchiness, swelling of the face, hands and joints.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The patient, was thought to be the incorrect name and spelling.  Due to this she received the Adult Pfizer Vaccine instead of the Pediatric Pfizer Vaccine.  This error was identified at store 36 when the patient and her father showed up for a pediatric bivalent booster vaccine.  We asked the father for her COVID card and her insurance information. He stated he didn't have either.  When we added her into the system we searched and generated her information and he admitted she did have insurance.  Once entering the Pediatric Bivalent booster I searched for the patient and could not find her primary pediatric series.  I asked her father again if he had any evidence of her primary series and he then produced her COVID card and it had the incorrect spelling and DOB.  I explained the error to the father and at this point we decided to give her the Pediatric Pfizer booster.  It is unclear if the father purposefully filled the patient's information incorrectly or if this was truly and accident.  The father stated he did not give us the INS information because he heard on the news that it was better if they did not present the INS information.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Diabetes mellitus, Tinnitus
Clinical narrative: Hearing my heart beat in my ear. Diagnosed with Diabetes
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: PT WAS GIVEN THE ADULT DOSE (AGE 12 AND UP). SHE IS 11 YEARS OLD. MOTHER WAS ADVISED 20 MINUTES AFTER THE INJECTION WHEN WE REALIZED WHAT HAD HAPPENED. MOTHER SAID NO PROBLEM BECAUSE HER DAUGHER IS BIG FOR HER AGE. TICKET NUMBER WITH OUR HELP DESK
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Dermatitis, Pruritus, Scratch, Skin haemorrhage, Urticaria
Clinical narrative: Patient reported day after vaccine having extremely itchy skin, so much so that she had skin welts and inflammation. Patient also reported welts started bleeding after scratching them. She took benadryl every 4-6 hours for symtoms and no has relief. Patient reported never having had any kind of reaction before from a vaccine.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills,aches,fever, headache
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: Tinnitus, continuous since onset. It has never improved. No treatment yet but will begin looking for options soon. Difficult to function with it sometimes, but I'm managing okay.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Pt has received anthrax vaccine Jan 2018, Jan 2020, and now Dec 2022.  One day letter urticaria developed across his body and he went to the urgent care 2 days after the vaccine was administered.  No anaphylaxis.  Pt has no history of food allergies, asthma, eczema etc.  No new foods introduced.  No medications other than Naproxen PRN which he had utilized for years.  No chronic conditions.  Pt is healthy and has a well documented medical record since he is tracked by clinic.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing sensation in left ear, feels stronger when i grind my teeth
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Immediate post-injection reaction, Incorrect dose administered, Incorrect route of product administration
Clinical narrative: On 08-05-2022 I received my 2nd COVID booster vaccination at local Medical Care Clinic at about 10am in the facility parking lot. The medical assistant or nurses assistant who injected me administered the injection in my AC joint instead of my deltoid. According to the local Public Health investigator, the facility medical record indicated I received an incorrect dose for my 4th shot. I felt uncomfortable immediately but at around 11am that day I began to feel sharp pains in my shoulder. By that night and over the weekend I was writhing in pain. Every position hurt. I could not sit, stand, walk, lay down, or sleep without acute pain. There were sharp shooting pains from my left shoulder, my neck on the left side, and down to my inner left elbow. It was so painful that I kept a pain diary in my patient portal begging for help. Daily at time. On Aug 9, I visited my regular clinic at the local Medical Care Clinic to get a proper diagnosis. Instead, the doctor asked me what care I thought I should receive.  Treatment: In pain, I rattled off what I thought I needed to get relief and a proper diagnosis. I suggested an X-ray, MRI, orthopedic specialist to start. Before I left her she prescribed steroids for me to take to help ease the inflammation. From Aug 29 - Dec 20 2022 I was in treatment. I was seen by an acupuncturist and had several sessions of physical therapy based on the orthopedic surgeon's medical advice.  Outcome: I am still in pain. My diagnosis received on 12-16-2022 Persistent left shoulder pain following misplaced vaccination. Overall, patient has markedly improved. Currently she is reporting 65% resolution of her pain and decreased range of motion. At this time, no further intervention seems warranted. Patient is healing and needs time to complete resolution. Encouraged follow-up in 2 months.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Joint range of motion decreased, Magnetic resonance imaging, Neck pain, Pain
Clinical narrative: On 08-05-2022 I received my 2nd COVID booster vaccination at local Medical Care Clinic at about 10am in the facility parking lot. The medical assistant or nurses assistant who injected me administered the injection in my AC joint instead of my deltoid. According to the local Public Health investigator, the facility medical record indicated I received an incorrect dose for my 4th shot. I felt uncomfortable immediately but at around 11am that day I began to feel sharp pains in my shoulder. By that night and over the weekend I was writhing in pain. Every position hurt. I could not sit, stand, walk, lay down, or sleep without acute pain. There were sharp shooting pains from my left shoulder, my neck on the left side, and down to my inner left elbow. It was so painful that I kept a pain diary in my patient portal begging for help. Daily at time. On Aug 9, I visited my regular clinic at the local Medical Care Clinic to get a proper diagnosis. Instead, the doctor asked me what care I thought I should receive.  Treatment: In pain, I rattled off what I thought I needed to get relief and a proper diagnosis. I suggested an X-ray, MRI, orthopedic specialist to start. Before I left her she prescribed steroids for me to take to help ease the inflammation. From Aug 29 - Dec 20 2022 I was in treatment. I was seen by an acupuncturist and had several sessions of physical therapy based on the orthopedic surgeon's medical advice.  Outcome: I am still in pain. My diagnosis received on 12-16-2022 Persistent left shoulder pain following misplaced vaccination. Overall, patient has markedly improved. Currently she is reporting 65% resolution of her pain and decreased range of motion. At this time, no further intervention seems warranted. Patient is healing and needs time to complete resolution. Encouraged follow-up in 2 months.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration, Sleep disorder, X-ray
Clinical narrative: On 08-05-2022 I received my 2nd COVID booster vaccination at local Medical Care Clinic at about 10am in the facility parking lot. The medical assistant or nurses assistant who injected me administered the injection in my AC joint instead of my deltoid. According to the local Public Health investigator, the facility medical record indicated I received an incorrect dose for my 4th shot. I felt uncomfortable immediately but at around 11am that day I began to feel sharp pains in my shoulder. By that night and over the weekend I was writhing in pain. Every position hurt. I could not sit, stand, walk, lay down, or sleep without acute pain. There were sharp shooting pains from my left shoulder, my neck on the left side, and down to my inner left elbow. It was so painful that I kept a pain diary in my patient portal begging for help. Daily at time. On Aug 9, I visited my regular clinic at the local Medical Care Clinic to get a proper diagnosis. Instead, the doctor asked me what care I thought I should receive.  Treatment: In pain, I rattled off what I thought I needed to get relief and a proper diagnosis. I suggested an X-ray, MRI, orthopedic specialist to start. Before I left her she prescribed steroids for me to take to help ease the inflammation. From Aug 29 - Dec 20 2022 I was in treatment. I was seen by an acupuncturist and had several sessions of physical therapy based on the orthopedic surgeon's medical advice.  Outcome: I am still in pain. My diagnosis received on 12-16-2022 Persistent left shoulder pain following misplaced vaccination. Overall, patient has markedly improved. Currently she is reporting 65% resolution of her pain and decreased range of motion. At this time, no further intervention seems warranted. Patient is healing and needs time to complete resolution. Encouraged follow-up in 2 months.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Urticaria
Clinical narrative: 12-19-2022 PENTACEL GIVEN FOR THE FIRST TIME AT 4 MONTHS. PATIENT HAD PEDIARIX AT 2 MOS. OLD ON 10-17-2022. 10:20 AM, 12-19-2022 PENTACEL GIVEN. 12:20 PM MOTHER CALLS & SENDS PICTURES OF HIVES TO RIGHT SIDE OF BODY. SAID HIVES ARE GOING AWAY SLOWLY. BREATHING OKAY. NO FUSSINESS OR SCRATCHING. 12-19-2022, 2:56 PM PHONE CALL W/MOTHER. SAID REDNESS/HIVES, MOST OF IT HAS GONE AWAY. BREATHING ALRIGHT
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gingival bleeding, Rash
Clinical narrative: PATIENT SAID SHE GOT A RASH FOR 1 DAY AND BLEEDING IN GUMS WHICH SHE STILL HAD SOME TODAY.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-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 13-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication information provided.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna COVID-19 Bivalent after 30 day use by date.  No treatment information provided.   This case was linked to MOD-2022-687538, MOD-2022-687539, MOD-2022-687540, MOD-2022-687541, MOD-2022-687542 (E2B Linked Report).; Sender's Comments:  MOD-2022-687541:Original Case : MOD-2022-687454 MOD-2022-687540:Original Case : MOD-2022-687454 MOD-2022-687539:Original Case : MOD-2022-687454 MOD-2022-687542:Original Case : MOD-2022-687454 MOD-2022-687538:Original Case : MOD-2022-687454
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-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 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication was provided by the reporter.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna COVID-19 Bivalent after 30 day use by date.  No treatment medication was provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure acute, Cardiac failure congestive, Influenza virus test positive, Left ventricular failure
Clinical narrative: Date Of Admission : 10/19/2022   Date Of Discharge :   10/22/22  Primary Diagnosis : #.  COVID-19 virus infection #.  Acute on chronic diastolic congestive heart failure  - RESOLVED #. History of accelerated junctional rhythm -on flecainide #.   Possible paroxysmal atrial fibrillation #. Asthma / COPD - not in exacerbation #. Hypothyroidism -continue Synthroid
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory syncytial virus test positive, SARS-CoV-2 test positive
Clinical narrative: Date Of Admission : 10/19/2022   Date Of Discharge :   10/22/22  Primary Diagnosis : #.  COVID-19 virus infection #.  Acute on chronic diastolic congestive heart failure  - RESOLVED #. History of accelerated junctional rhythm -on flecainide #.   Possible paroxysmal atrial fibrillation #. Asthma / COPD - not in exacerbation #. Hypothyroidism -continue Synthroid
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Biopsy breast abnormal, Breast cancer female, Breast mass, Computerised tomogram abnormal
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Negative; Test: breast cancer, notes: No genetics per either of our tests diagnosed this past year with the exact same type left breast cancer; Positron emission tomogram: Unknown results. Clinical course: The patient stated "I am trying to reach out to others or to medical world about Covid vaccine causing breast cancer. We do not have a family history. No genetics per either of our tests. Both myself and my 1st cousin were diagnosed this past year with the exact same type left breast cancer, same side, (we are different ages), same arm (vaccines all given in left arm). Both within 8-10 months of getting Pfizer 2 shots and 1 booster. I even had pet scan month before my first shot due to funny blood work, negative. "  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gene mutation identification test negative, Malaise, Mammogram abnormal, Nodule
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Negative; Test: breast cancer, notes: No genetics per either of our tests diagnosed this past year with the exact same type left breast cancer; Positron emission tomogram: Unknown results. Clinical course: The patient stated "I am trying to reach out to others or to medical world about Covid vaccine causing breast cancer. We do not have a family history. No genetics per either of our tests. Both myself and my 1st cousin were diagnosed this past year with the exact same type left breast cancer, same side, (we are different ages), same arm (vaccines all given in left arm). Both within 8-10 months of getting Pfizer 2 shots and 1 booster. I even had pet scan month before my first shot due to funny blood work, negative. "  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Positron emission tomogram abnormal, Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Negative; Test: breast cancer, notes: No genetics per either of our tests diagnosed this past year with the exact same type left breast cancer; Positron emission tomogram: Unknown results. Clinical course: The patient stated "I am trying to reach out to others or to medical world about Covid vaccine causing breast cancer. We do not have a family history. No genetics per either of our tests. Both myself and my 1st cousin were diagnosed this past year with the exact same type left breast cancer, same side, (we are different ages), same arm (vaccines all given in left arm). Both within 8-10 months of getting Pfizer 2 shots and 1 booster. I even had pet scan month before my first shot due to funny blood work, negative. "  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast cancer, Investigation, Positron emission tomogram
Clinical narrative: breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Negative; Test: breast cancer, notes: No genetics per either of our tests diagnosed this past year with the exact same type left breast cancer; Positron emission tomogram: Unknown results. Clinical course: The patient stated "I am trying to reach out to others or to medical world about Covid vaccine causing breast cancer. We do not have a family history. No genetics per either of our tests. Both myself and my 1st cousin were diagnosed this past year with the exact same type left breast cancer, same side, (we are different ages), same arm (vaccines all given in left arm). Both within 8-10 months of getting Pfizer 2 shots and 1 booster. I even had pet scan month before my first shot due to funny blood work, negative. "  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I had minor chills, mild fever never over 100, a little coughing, and sore throat. I tested positive for COVID-19 at home. I spoke to my doctor, and he prescribed me PAXLOVID. I started feeling better after a few days.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Chills, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: I had minor chills, mild fever never over 100, a little coughing, and sore throat. I tested positive for COVID-19 at home. I spoke to my doctor, and he prescribed me PAXLOVID. I started feeling better after a few days.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had minor chills, mild fever never over 100, a little coughing, and sore throat. I tested positive for COVID-19 at home. I spoke to my doctor, and he prescribed me PAXLOVID. I started feeling better after a few days.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: ; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (She had the warmth), VACCINATION SITE INDURATION (Still has the hardening and swelling on the injection) and VACCINATION SITE SWELLING (She had the warmth and swelling) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057P22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-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 October 2022, the patient experienced VACCINATION SITE WARMTH (She had the warmth), VACCINATION SITE INDURATION (Still has the hardening and swelling on the injection) and VACCINATION SITE SWELLING (She had the warmth and swelling). At the time of the report, VACCINATION SITE WARMTH (She had the warmth), VACCINATION SITE INDURATION (Still has the hardening and swelling on the injection) and VACCINATION SITE SWELLING (She had the warmth and swelling) had not 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 reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had previously received Moderna primary series and Moderna booster, all in left arm.  The patient experienced a delayed but harmless allergic reaction. Patient had the warmth and swelling, but not itchy nor hurt. It took a couple of days before it appeared and now patient still had the hardening and swelling on the injection. Patient had no problems with the other ones.  No treatment medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: ; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (She had the warmth), VACCINATION SITE INDURATION (Still has the hardening and swelling on the injection) and VACCINATION SITE SWELLING (She had the warmth and swelling) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057P22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-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 October 2022, the patient experienced VACCINATION SITE WARMTH (She had the warmth), VACCINATION SITE INDURATION (Still has the hardening and swelling on the injection) and VACCINATION SITE SWELLING (She had the warmth and swelling). At the time of the report, VACCINATION SITE WARMTH (She had the warmth), VACCINATION SITE INDURATION (Still has the hardening and swelling on the injection) and VACCINATION SITE SWELLING (She had the warmth and swelling) had not 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 reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had previously received Moderna primary series and Moderna booster, all in left arm.  The patient experienced a delayed but harmless allergic reaction. Patient had the warmth and swelling, but not itchy nor hurt. It took a couple of days before it appeared and now patient still had the hardening and swelling on the injection. Patient had no problems with the other ones.  No treatment medication was reported.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Pyrexia, Stomatitis
Clinical narrative: dizziness; cold sore; tiredness; headache; left arm sore; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 12th December 2022, 11 days after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced dizziness, cold sores, tiredness, headache and pain in arm. On an unknown date, the outcome of the dizziness, cold sores, tiredness, headache and pain in arm were recovering/resolving.   It was unknown if the reporter considered the dizziness, cold sores, tiredness, headache and pain in arm to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment: The patient self-reported this case. The reporter stated that the patient had Fluarix shot and experienced dizziness, tiredness, headache, cold sore, and her left arm was sore.   The reporter stated that symptoms were improving, but they were still present. The reporter did not give consent to follow up. Additional Supportive Information: The outcome of events was captured conservatively as recovering as per description reported.
Age: 57.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dizziness, Fatigue, Headache, Oral herpes, Pain in extremity
Clinical narrative: dizziness; cold sore; tiredness; headache; left arm sore; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 57-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 12th December 2022, 11 days after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced dizziness, cold sores, tiredness, headache and pain in arm. On an unknown date, the outcome of the dizziness, cold sores, tiredness, headache and pain in arm were recovering/resolving.   It was unknown if the reporter considered the dizziness, cold sores, tiredness, headache and pain in arm to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment: The patient self-reported this case. The reporter stated that the patient had Fluarix shot and experienced dizziness, tiredness, headache, cold sore, and her left arm was sore.   The reporter stated that symptoms were improving, but they were still present. The reporter did not give consent to follow up. Additional Supportive Information: The outcome of events was captured conservatively as recovering as per description reported.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Erythema, Facial paresis
Clinical narrative: Had covid and Paxlovid had a rebound; Had covid and Paxlovid had a rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovered" (24Jun2022) and all described as "Had covid and Paxlovid had a rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive; (10Jun2022) Negative; (16Jun2022) Positive, notes: Rebound; (17Jun2022) Positive; (22Jun2022) Positive, notes: Covid test positive; (24Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Event experienced: My first Covid vaccine Pfizer, Date started: 28Jan2021, Admission to hospital due to the event: No, Still experiencing: Fine now. On 04Jun2022, she started to take the Paxlovid for Covid. On 09Jun2022, last dose of Paxlovid, felt very well. 10Jun2022, Covid test negative. Felt very good until  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Muscular weakness
Clinical narrative: Had covid and Paxlovid had a rebound; Had covid and Paxlovid had a rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovered" (24Jun2022) and all described as "Had covid and Paxlovid had a rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive; (10Jun2022) Negative; (16Jun2022) Positive, notes: Rebound; (17Jun2022) Positive; (22Jun2022) Positive, notes: Covid test positive; (24Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Event experienced: My first Covid vaccine Pfizer, Date started: 28Jan2021, Admission to hospital due to the event: No, Still experiencing: Fine now. On 04Jun2022, she started to take the Paxlovid for Covid. On 09Jun2022, last dose of Paxlovid, felt very well. 10Jun2022, Covid test negative. Felt very good until  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had covid and Paxlovid had a rebound; Had covid and Paxlovid had a rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jun2022, outcome "recovered" (24Jun2022) and all described as "Had covid and Paxlovid had a rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive; (10Jun2022) Negative; (16Jun2022) Positive, notes: Rebound; (17Jun2022) Positive; (22Jun2022) Positive, notes: Covid test positive; (24Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Event experienced: My first Covid vaccine Pfizer, Date started: 28Jan2021, Admission to hospital due to the event: No, Still experiencing: Fine now. On 04Jun2022, she started to take the Paxlovid for Covid. On 09Jun2022, last dose of Paxlovid, felt very well. 10Jun2022, Covid test negative. Felt very good until  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Bronchitis, Depression, Fatigue, Feeling abnormal
Clinical narrative: acute COVID infection; acute COVID infection; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "COVID infection", start date: Nov2020, stop date: Nov2020, notes: 1st in Nov2020 before the vaccines; "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing).  The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "acute COVID infection".  Clinical course: I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201378213 same reporter/patient  drug, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Mental disorder
Clinical narrative: acute COVID infection; acute COVID infection; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "COVID infection", start date: Nov2020, stop date: Nov2020, notes: 1st in Nov2020 before the vaccines; "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing).  The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "acute COVID infection".  Clinical course: I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201378213 same reporter/patient  drug, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: acute COVID infection; acute COVID infection; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A 47-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "COVID infection", start date: Nov2020, stop date: Nov2020, notes: 1st in Nov2020 before the vaccines; "being u thyroid since 2004", start date: 2004 (unspecified if ongoing); "Celiac disease" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing).  The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "acute COVID infection".  Clinical course: I have had an acute COVID infection twice, both times contracted from work, as I work in healthcare as support staff, 1st in Nov2020 before the vaccines, the 2nd time after receiving both COVID Pfizer vaccines and 2 boosters; in Nov2022. The first time I had pneumonia in my left lung and the 2nd time I had bronchitis and inflammation in my bronchial tubes. I'm still experiencing brain fog, exhaustion, joint aches and general malaise; as well as worsening depression & mental health both times. The 2nd infection occurred while working in a cancer clinic as a Medical Assistant, where I still work. The 1st infection, I was working as a personal care aide at an assisted living home. I'm 47, a single mother of 3, have a somewhat weakened immune system from being u thyroid since 2004 & having Celiac disease as well as high blood pressure. Both infections I believe occurred due to other coworkers improperly wearing masks or not wearing them at all at work. I even lost time from work that I was not paid for-both times, the I practice safe hand hygiene, wear a mask at my job and stayed home and isolated from my own kids and to protect the patients I help care for."   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201378213 same reporter/patient  drug, different dose/event;
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Cerebral thrombosis, Computerised tomogram head abnormal, Confusional state, Dizziness postural
Clinical narrative: On 12.21.2022 patient had acute onset of confusion, dizziness upon standing, and shortness of breath at a restaurant. EMS was called and patient was brought to the ER.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Magnetic resonance imaging head abnormal, X-ray
Clinical narrative: On 12.21.2022 patient had acute onset of confusion, dizziness upon standing, and shortness of breath at a restaurant. EMS was called and patient was brought to the ER.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Dyspnoea, Fluid retention, Pulmonary hypertension
Clinical narrative: 1st noticed retention of fluids in lower abdomen on 01/15/2022 with extreme shortness of breath.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 as dose 5 (booster), single (Lot number: CH9693) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 11Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FA7484) and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Dec2022 at 18:00, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Nov2022) Positive; (07Dec2022) Positive, notes: I got home antigen test and it went positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: On Monday, 05Nov2022 my husband tested positive for COVID-19. On Wednesday, 07Dec2022, I started having COVID-19 symptoms (fever, nasal congestion, sore throat, and cough). I got home antigen test and it went positive. On that same Wednesday at night, I started PAXLOVID. I finished treatment with PAXLOVID. The patient did not take other medication in 2 weeks. The patient was treated with Paxlovid (Lot number: 1923792A) from 07Dec2022 to 12Dec2022, indication: Treatment of COVID-19. Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out