chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Vertigo
Clinical narrative: Dose #1: 02/2021 Dose #2: 03/2021 Dose #3: 10/2021 Dose#4:  09/15/2022. After receiving Dose #4, I woke up the next day with considerable dizziness. As soon as I lifted my head off of the pillow, I felt the room spinning and extremely dizzy (almost nauseating). I rested my head back down immediately and closed my eyes until it passed (less than a minute). Slowly, I sat back up felt dizzy again so I closed my eyes and waited until it passed (still sitting up). I then stood up and nearly lost my balance, dizzy again. After a few minutes, I tried to get up again and slowly, I was able to do so, however, I kept feeling small bout of dizziness that were shorter in duration. I decided to stay home that day as I was afraid I would lose my balance and fall, much less, be able to drive. The next day, I woke up dizzy again and it lasted throughout the day-but much shorter in duration from onset to recovery (happens only after moving my head up from a rested position). As time progresses, I still feel dizzy but am able to drive and carry out my daily routine-albeit with short episodes of dizziness. With each day, I feel it is slowly resolving, very slowly. I am otherwise healthy, 5'3"; 144lbs and a mother of 3. No medications and live an active lifestyle; no major health related surgeries or physical trauma.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Light headed  Headache
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, FLU4
Symptoms: Amyotrophic lateral sclerosis, Balance disorder, Dysarthria, Electromyogram abnormal, Muscle atrophy
Clinical narrative: I developed leg weakness in august, 2021.  In Oct. 2021, I developed a left foot drop. November/December balance issues and continued weakness in legs.  December, 2021  through  March 2022, muscle wasting and significant weight loss. March 2022, Speech getting slurred. Diagnosed with ALS May, 2022.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, FLU4
Symptoms: Muscular weakness, Nerve conduction studies abnormal, Peroneal nerve palsy, Weight decreased
Clinical narrative: I developed leg weakness in august, 2021.  In Oct. 2021, I developed a left foot drop. November/December balance issues and continued weakness in legs.  December, 2021  through  March 2022, muscle wasting and significant weight loss. March 2022, Speech getting slurred. Diagnosed with ALS May, 2022.
Age: 36.0
Sex: U
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Asymptomatic
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Atrial flutter, Cardiac ablation, Dizziness, Electrocardiogram abnormal
Clinical narrative: I developed AFlutter (a form of Atrial Fibrillation) as a result of getting the Pfizer Booster. My first two vaccines were Moderna. According to my heart rate data that is tracked on my device, since 2018 my resting heart rate has been approximately 60bpm. I received the Pfizer booster on November 15, 2021. In mid-December 2021, my resting heart rate data increased to 70bpm.  In March & April 2022, I started to have dizzy/fainting episodes. On my first visit to an ER on 4/12/2022, I was diagnosed  with AFlutter immediately. My symptoms persisted and I had an ablation procedure on June 14, 2022 to correct the AFlutter. At my 3 week post-procedure check-up, my heart rhythm was normal again, as was my resting heart rate. On my device data, my resting heart rate has been approximately 60bpm since my ablation procedure. I have not had any additional booster vaccines since the one I had November 15, 2021.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate increased, Syncope
Clinical narrative: I developed AFlutter (a form of Atrial Fibrillation) as a result of getting the Pfizer Booster. My first two vaccines were Moderna. According to my heart rate data that is tracked on my device, since 2018 my resting heart rate has been approximately 60bpm. I received the Pfizer booster on November 15, 2021. In mid-December 2021, my resting heart rate data increased to 70bpm.  In March & April 2022, I started to have dizzy/fainting episodes. On my first visit to an ER on 4/12/2022, I was diagnosed  with AFlutter immediately. My symptoms persisted and I had an ablation procedure on June 14, 2022 to correct the AFlutter. At my 3 week post-procedure check-up, my heart rhythm was normal again, as was my resting heart rate. On my device data, my resting heart rate has been approximately 60bpm since my ablation procedure. I have not had any additional booster vaccines since the one I had November 15, 2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Magnetic resonance imaging spinal abnormal, Neuropathy peripheral, Sensory loss, Spinal X-ray abnormal
Clinical narrative: Woke up and could not feel my feet completely. Called doc off at Medical and had a telehealth appointment with. I explained that I had had the COVID booster 5 days before and not sure if it was reported. She placed me on gabapentin for neuropathy due to possible sciatic issues and it helped slightly- changed providers. Was sent for X-rays, MRI, blood work.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal osteoarthritis
Clinical narrative: Woke up and could not feel my feet completely. Called doc off at Medical and had a telehealth appointment with. I explained that I had had the COVID booster 5 days before and not sure if it was reported. She placed me on gabapentin for neuropathy due to possible sciatic issues and it helped slightly- changed providers. Was sent for X-rays, MRI, blood work.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: injection received Fri 9.16.22 approx 12:45 pm. That evening approx 7pm patient had pain at injection site--radiated to entire shoulder and arm. Site felt "puffed up" about 1/2 inch high and 2 inches across. Says  hurt to  touch or move arm,. Pain worse next day, but decreasing on Sunday. Day 4 (Mon) I saw arm-no redness or rash, no noticeable raised area at injection site (did not remove bandage), still has some pain, but feels much better. Never noticed any fever or other symptoms.
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site bruising, Injection site discomfort, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Hard lump, itching, injection site tenderness and discomfort, bruising
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site pruritus
Clinical narrative: Hard lump, itching, injection site tenderness and discomfort, bruising
Age: 16.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse drug reaction.  The wrong drug was given to the patient.  The patient was supposed to receive Pneumococcal polysaccharide and pneumococcal conjugate was ordered incorrectly. There is no need to re-administer an additional vaccine and that adverse effects (caused by the incorrect vaccine) are not expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Faeces soft, Stool analysis normal
Clinical narrative: every few hours there would be a severe gripe midline just below waist, like 2 hands pushing insides together; enough to make me double over (and I tolerate pain quite well).  Followed by eventually an unusual kind of diarrhea/soft stool of unusual lumpy consistency . But flowing out but not real wet like diarrhea.  This event would happen about every 4 hours.  It lasted for 6 weeks then the gripe and soft stool quit.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Hyperhidrosis, Laboratory test, Non-Hodgkin's lymphoma
Clinical narrative: My father developed non-Hodgkin's lymphoma soon after the booster shot he received in October 2021. Up to that point he was mobile and pretty healthy for his age. As soon as he received the booster shot (third dose) he started having severe back pain and extreme sweats.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Rash pruritic
Clinical narrative: Redness on skin in areas including the front of the neck, across the collar bone, and across the upper chest.  Area is very itchy and slightly bumpy. Not blotchy but all of area is red. Using Benadryl cream on skin and taking Benadryl tablets. As of 9/19/2022 at 8:53 pm there has not been improvement.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Condition aggravated, Essential hypertension, Inappropriate schedule of product administration
Clinical narrative: Patient received Moderna COVID vaccine on 2/28/21 (lot # 024M20A), 3/8/21 (lot # 001B21A), and Pfizer COVID vaccine on 11/4/21 (lot # FE3590). On 9/14/22, patient admitted to our inpatient facility med/surg unit with acute hypoxic respiratory failure likely due to community-acquired pneumonia as well as COVID infection and essential hypertension. Patient discharged on 9/19/22.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient received Moderna COVID vaccine on 2/28/21 (lot # 024M20A), 3/8/21 (lot # 001B21A), and Pfizer COVID vaccine on 11/4/21 (lot # FE3590). On 9/14/22, patient admitted to our inpatient facility med/surg unit with acute hypoxic respiratory failure likely due to community-acquired pneumonia as well as COVID infection and essential hypertension. Patient discharged on 9/19/22.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bone disorder, Gait disturbance, Loss of personal independence in daily activities, Pain, Rheumatoid arthritis
Clinical narrative: Early on I went to Hosp for trying to find out what was wrong but was never diagnosed after about 3 months of time, early the next year I switched to another Hospital and a new doctor and in less than a month, the diagnosis of Rheumatoid Arthritis was made and I began treatment for that disease. It is difficult to be exact as the symptoms at became more intense with time until it was painful to walk at all.  The Rheumatoid Arthritis is in my feet and legs.  I had been a walker up until that time and walked about 3 miles a day and thoroughly enjoyed my walks. I had to give up my walks with that diagnosis. Clonidine HCL Amlodipine Besylate Bisoprolol Fumarate Latanoprost Levothyroxin synthroid First shot was at the filre station, the second was at a Church and I believe after that, the last two were at a School now owned by a College. A personal note.  I couldn't understand what would have triggered this reaction that caused my body to attack itself after being so healthy for so long.  It did not make sense and at first, I did not suspect the covid shots but more and more, after thinking about it. It was the only change that I had made in my health care over that particular time and it was not just one dose but 4 doses in a very short time.  The only other vaccination I had was the flue shot and I have never reacted to that in a negative way before.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: X-ray abnormal
Clinical narrative: Early on I went to Hosp for trying to find out what was wrong but was never diagnosed after about 3 months of time, early the next year I switched to another Hospital and a new doctor and in less than a month, the diagnosis of Rheumatoid Arthritis was made and I began treatment for that disease. It is difficult to be exact as the symptoms at became more intense with time until it was painful to walk at all.  The Rheumatoid Arthritis is in my feet and legs.  I had been a walker up until that time and walked about 3 miles a day and thoroughly enjoyed my walks. I had to give up my walks with that diagnosis. Clonidine HCL Amlodipine Besylate Bisoprolol Fumarate Latanoprost Levothyroxin synthroid First shot was at the filre station, the second was at a Church and I believe after that, the last two were at a School now owned by a College. A personal note.  I couldn't understand what would have triggered this reaction that caused my body to attack itself after being so healthy for so long.  It did not make sense and at first, I did not suspect the covid shots but more and more, after thinking about it. It was the only change that I had made in my health care over that particular time and it was not just one dose but 4 doses in a very short time.  The only other vaccination I had was the flue shot and I have never reacted to that in a negative way before.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Axillary pain, Swelling
Clinical narrative: Patient wife call say Patient has swelling & paint in left axilla area We have contacted Patient's PCP.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5 hrs. after shot arm was in extreme pain from end of clavicle to about 2 inches below on the arm. redness and swelling. Left arm
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent covid vaccine administered as booster after FDA authorization.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient expired 9/22/2021
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: congestion, cough, chest tightness, SOB, wheezing, abdominal pain, nausea, vomiting, myalgias
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest discomfort, Cough, Dyspnoea, Myalgia
Clinical narrative: congestion, cough, chest tightness, SOB, wheezing, abdominal pain, nausea, vomiting, myalgias
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Respiratory tract congestion, Vomiting, Wheezing
Clinical narrative: congestion, cough, chest tightness, SOB, wheezing, abdominal pain, nausea, vomiting, myalgias
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 4 years old at the time of vaccination. The patient's mother had stated on clinic paperwork that he was 5 years old, and the clinic had no record of this patient in our system to verify that information. The patient was vaccinated with Peds Pfizer (5-11 yrs) under the assumption that the patient was 5 years old. It was discovered later the same day that the patient was only 4 years old and should not have been eligible for the Peds Pfizer vaccine. There are no known adverse events that occurred as a result of this.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was 4 years old at the time of vaccination. The patient's mother had stated on clinic paperwork that he was 5 years old, and the clinic had no record of this patient in our system to verify that information. The patient was vaccinated with Peds Pfizer (5-11 yrs) under the assumption that the patient was 5 years old. It was discovered later the same day that the patient was only 4 years old and should not have been eligible for the Peds Pfizer vaccine. There are no known adverse events that occurred as a result of this.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 39 years 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 was not reported. Concomitant medication(s) included: CETIRIZINE [CETIRIZINE HYDROCHLORIDE]; PSEUDOEPHEDRINE; GUAIFENESIN; TIRZEPATIDE; IBUPROFEN. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 39.0
Sex: F
Vaccine: COVID19, 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) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 39 years 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 was not reported. Concomitant medication(s) included: CETIRIZINE [CETIRIZINE HYDROCHLORIDE]; PSEUDOEPHEDRINE; GUAIFENESIN; TIRZEPATIDE; IBUPROFEN. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Grip strength decreased, Inappropriate schedule of product administration, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: It started almost immediately. Pain radiating up and down my arm. Some days I can barely use that arm. It makes my neck ache and wearing a seat belt is painful. I reported to moderna. They acted like I'm the only one this has happened to.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: It started almost immediately. Pain radiating up and down my arm. Some days I can barely use that arm. It makes my neck ache and wearing a seat belt is painful. I reported to moderna. They acted like I'm the only one this has happened to.
Sex: F
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: . Patient has not experienced any side effects; MMR II was accidentally administered to a patient intramuscularly instead of subcutaneously; This spontaneous report was received from a nurse and refers to a 31-year-old female.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-AUG-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  0.5 milliliter, once (one time dose) administered intramuscularly for prophylaxis (lot #U029794, expiration date: 23-SEP-2023). The nurse reported that the vaccine was accidentally administered intramuscularly instead of subcutaneously, given in the wrong route (Incorrect route of product administration). The patient has not experienced any side effects and tolerated well the vaccine.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Feeling cold, Incorrect product formulation administered, Pain, Pyrexia
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Malaise, Pain, Pyrexia
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect route of product administration
Clinical narrative: I was given the COVID booster shot SQ, not IM. The nurse firmly squeezed a large portion of my left upper arm and gave the shot .  I weigh 165 pounds , 5 foot 6 inches, and have large fatty upper arms . I am an RN and didn't realize until it was done that I was given a SQ, not IM vaccine. I am looking for guidance on what to do ? Should I get a second booster ? I have contacted my doctor and also the pharmacist , where I received the vaccine . No one has an answer for what I should do. Was the vaccine effective, even if it was given in into SQ tissue with poor circulation.? I had minimal reaction to this last vaccine. Just a tiny bit of soreness at the site. No swelling, redness or warmth at the site.
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: I was given the COVID booster shot SQ, not IM. The nurse firmly squeezed a large portion of my left upper arm and gave the shot .  I weigh 165 pounds , 5 foot 6 inches, and have large fatty upper arms . I am an RN and didn't realize until it was done that I was given a SQ, not IM vaccine. I am looking for guidance on what to do ? Should I get a second booster ? I have contacted my doctor and also the pharmacist , where I received the vaccine . No one has an answer for what I should do. Was the vaccine effective, even if it was given in into SQ tissue with poor circulation.? I had minimal reaction to this last vaccine. Just a tiny bit of soreness at the site. No swelling, redness or warmth at the site.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: No Adverse Event; A lot of Bivalent liquid leaked out of her arm during vaccination; A lot of Bivalent liquid leaked out of her arm during vaccination; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (A lot of Bivalent liquid leaked out of her arm during vaccination), DEVICE CONNECTION ISSUE (A lot of Bivalent liquid leaked out of her arm during vaccination) and NO ADVERSE EVENT (No Adverse Event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2022, the patient received fifth 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-Sep-2022, the patient experienced UNDERDOSE (A lot of Bivalent liquid leaked out of her arm during vaccination) and DEVICE CONNECTION ISSUE (A lot of Bivalent liquid leaked out of her arm during vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (A lot of Bivalent liquid leaked out of her arm during vaccination), DEVICE CONNECTION ISSUE (A lot of Bivalent liquid leaked out of her arm during vaccination) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant product use was reported.  The patient received 4 Monovalent doses (first dose, second dose, first and 2nd monovalent boosters) of COVID-19 vaccine.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: No Adverse Event; A lot of Bivalent liquid leaked out of her arm during vaccination; A lot of Bivalent liquid leaked out of her arm during vaccination; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (A lot of Bivalent liquid leaked out of her arm during vaccination), DEVICE CONNECTION ISSUE (A lot of Bivalent liquid leaked out of her arm during vaccination) and NO ADVERSE EVENT (No Adverse Event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2022, the patient received fifth 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-Sep-2022, the patient experienced UNDERDOSE (A lot of Bivalent liquid leaked out of her arm during vaccination) and DEVICE CONNECTION ISSUE (A lot of Bivalent liquid leaked out of her arm during vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (A lot of Bivalent liquid leaked out of her arm during vaccination), DEVICE CONNECTION ISSUE (A lot of Bivalent liquid leaked out of her arm during vaccination) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant product use was reported.  The patient received 4 Monovalent doses (first dose, second dose, first and 2nd monovalent boosters) of COVID-19 vaccine.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever; Severe headache; Body aches; Joint aches; Naseau; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypothyroid (Hashimotos)" (unspecified if ongoing), notes: Hypothyroid (Hashimotos); "Pre-diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Bee stings allergy" (unspecified if ongoing), notes: Bee stings allergy; "Adhesives allergy" (unspecified if ongoing), notes: Adhesives allergy; "COVID" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Fever"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Joint aches"; NAUSEA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Naseau"; HEADACHE (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Severe headache". Therapeutic measures were taken as a result of pyrexia, headache, pain, arthralgia, nausea.  Additional information: The patient did not receive any other vaccines with four weeks prior to the COVID vaccine. The patient received other medication within 2 weeks of vaccination. The patient received Tylenol for sleep. The patient was diagnosed to COVID prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pain, Photophobia, Pyrexia
Clinical narrative: Fever; Severe headache; Body aches; Joint aches; Naseau; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypothyroid (Hashimotos)" (unspecified if ongoing), notes: Hypothyroid (Hashimotos); "Pre-diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Bee stings allergy" (unspecified if ongoing), notes: Bee stings allergy; "Adhesives allergy" (unspecified if ongoing), notes: Adhesives allergy; "COVID" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Fever"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Joint aches"; NAUSEA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Naseau"; HEADACHE (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Severe headache". Therapeutic measures were taken as a result of pyrexia, headache, pain, arthralgia, nausea.  Additional information: The patient did not receive any other vaccines with four weeks prior to the COVID vaccine. The patient received other medication within 2 weeks of vaccination. The patient received Tylenol for sleep. The patient was diagnosed to COVID prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Severe headache; Body aches; Joint aches; Naseau; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypothyroid (Hashimotos)" (unspecified if ongoing), notes: Hypothyroid (Hashimotos); "Pre-diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Bee stings allergy" (unspecified if ongoing), notes: Bee stings allergy; "Adhesives allergy" (unspecified if ongoing), notes: Adhesives allergy; "COVID" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Body aches"; PYREXIA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Fever"; ARTHRALGIA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Joint aches"; NAUSEA (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Naseau"; HEADACHE (non-serious) with onset 13Sep2022 at 20:30, outcome "recovering", described as "Severe headache". Therapeutic measures were taken as a result of pyrexia, headache, pain, arthralgia, nausea.  Additional information: The patient did not receive any other vaccines with four weeks prior to the COVID vaccine. The patient received other medication within 2 weeks of vaccination. The patient received Tylenol for sleep. The patient was diagnosed to COVID prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient mom called to tell us that her daughter had a flu shot here on 9/13/22 and on 9/15/22 woke up with hives. She thinks it is linked to the shot. Patient took benadryl on 9/15/22, still had hives as of today 9/16/22. I advised patient to follow up with PCP and he suggested allergy testing for the patient to determine the root cause.
Age: 20.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient mom called to tell us that her daughter had a flu shot here on 9/13/22 and on 9/15/22 woke up with hives. She thinks it is linked to the shot. Patient took benadryl on 9/15/22, still had hives as of today 9/16/22. I advised patient to follow up with PCP and he suggested allergy testing for the patient to determine the root cause.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: tiredness for about 2 days; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness for about 2 days) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (tiredness for about 2 days). On 08-Apr-2021, FATIGUE (tiredness for about 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not seek any medical care for this adverse event.  It was reported that patient planned to get the Moderna COVID-19 Vaccine, bivalent soon.  No treatment was given for tiredness.   This case was linked to MOD-2022-643742, MOD-2022-643751 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: tiredness for about 2 days; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness for about 2 days) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (tiredness for about 2 days). On 08-Apr-2021, FATIGUE (tiredness for about 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not seek any medical care for this adverse event.  It was reported that patient planned to get the Moderna COVID-19 Vaccine, bivalent soon.  No treatment was given for tiredness.   This case was linked to MOD-2022-643742, MOD-2022-643751 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: We administered 0.25 ml instead of 0.5 ml
Age: 33.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: We administered 0.25 ml instead of 0.5 ml
Age: 79.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient came in on 9/16/22 and stated she got hives an hour after shot was given. Patient took Benadryl. Rash was all over her back.
Age: 79.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient came in on 9/16/22 and stated she got hives an hour after shot was given. Patient took Benadryl. Rash was all over her back.
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Bell's palsy, Dyskinesia, Eyelid function disorder, Facial paralysis, Facial paresis
Clinical narrative: Bell's Palsy, left side, onset 12 days after bivalent booster
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Hypoaesthesia oral
Clinical narrative: Bell's Palsy, left side, onset 12 days after bivalent booster
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Bell's palsy, Neurological examination abnormal
Clinical narrative: Bell's Palsy, left side, onset 12 days after bivalent booster
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Next day I have fever and rashes all over my body and transform in to big hives the side of a orange huge I still experienced hives all over this
Age: 34.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Patient had hives on the right side of face, especially right eye, starting around 4pm on 9/15.  He took a tablet of Claritin and 2 tablets of Advil.  The rash subsided next morning.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 - Tested POSITIVE September 4, 2022
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chest discomfort, Diarrhoea, Feeling hot, Headache, Lip swelling
Clinical narrative: Because of past allergic reactions in past, took a 25mg tablet of BENADRYL before dose 5. Received Flu vaccine along with Moderna dose 5 at the same time; Started feeling itchy and nauseous at 03:15; at 3:40 my lips and tongue started swelling and I started to have overwhelming chest pressure. Was already near pharmacy so I went back. I told the Pharmacist that I had an allergic reaction to dose 1. He sat with me and gave me a 4 ounce dose of BENADRYL. However, I forgot to mention that I'm allergic to red dye and my throat started closing. It was the cherry flavor and I'm allergic to red dye. I stayed 45 minutes for observation. I drank a lot of water per Pharmacist and took another BENADRYL 25mg, tablet. I started to feel better and went home; I had to take BENADRYL every 4 hours or I'd start feeling hot itchy again. I was afraid to sleep for too long. The next day on 09/17/2022 I started having a headache, diarrhea and congestion. I was able to stop taking BENADRYL on 09/18/2022.
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Nausea, Pruritus, Respiratory tract congestion, Swollen tongue
Clinical narrative: Because of past allergic reactions in past, took a 25mg tablet of BENADRYL before dose 5. Received Flu vaccine along with Moderna dose 5 at the same time; Started feeling itchy and nauseous at 03:15; at 3:40 my lips and tongue started swelling and I started to have overwhelming chest pressure. Was already near pharmacy so I went back. I told the Pharmacist that I had an allergic reaction to dose 1. He sat with me and gave me a 4 ounce dose of BENADRYL. However, I forgot to mention that I'm allergic to red dye and my throat started closing. It was the cherry flavor and I'm allergic to red dye. I stayed 45 minutes for observation. I drank a lot of water per Pharmacist and took another BENADRYL 25mg, tablet. I started to feel better and went home; I had to take BENADRYL every 4 hours or I'd start feeling hot itchy again. I was afraid to sleep for too long. The next day on 09/17/2022 I started having a headache, diarrhea and congestion. I was able to stop taking BENADRYL on 09/18/2022.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Discomfort, Fatigue
Clinical narrative: The night after getting the shot, I could tell I wasn't reacting well.  I woke up Sunday morning with chills and later had a temp of 100.8 degrees F.  I had a bad headache & muscle aches and didn't feel I could eat without risking throwing up.  I laid in bed all day taking sips of water I felt miserable and not comfortable enough to sleep until about 10pm Sunday night. I was still tired and achy Monday morning including painful stomach cramps but gradually felt better by Monday evening and felt well enough to eat a normal dinner Monday night.  Prior to that I had one egg Sunday and one egg Monday and about a dozen wheat thins, then some banana bread about 3pm Monday afternoon
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: The night after getting the shot, I could tell I wasn't reacting well.  I woke up Sunday morning with chills and later had a temp of 100.8 degrees F.  I had a bad headache & muscle aches and didn't feel I could eat without risking throwing up.  I laid in bed all day taking sips of water I felt miserable and not comfortable enough to sleep until about 10pm Sunday night. I was still tired and achy Monday morning including painful stomach cramps but gradually felt better by Monday evening and felt well enough to eat a normal dinner Monday night.  Prior to that I had one egg Sunday and one egg Monday and about a dozen wheat thins, then some banana bread about 3pm Monday afternoon
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Feeling abnormal, Headache, Heavy menstrual bleeding, Myalgia
Clinical narrative: Had a fever of 103.9 the next day with headache, muscle aches and congestion. I'm Postmenopausal and got my period. I went to my Dr. and had blood work drawn along with an Internal Ultrasound. Saw OBGYN and had a saline infusion sonogram. Results were inconclusive. Went to Endocrinologist and had a scan of my Thyroid, no nodules were found. Have been menstruating regularly ever since this dose. In 06/2022 I got a weird rash on my right wrist and started feeling bad again with a headache, fever and congestion. Had more blood work drawn, and tests were inconclusive. In 08/2022 had a severe heavy period. On 09/26/2022 am going to have my Uterus scraped and taken biopsies if needed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Pyrexia, Rash, Respiratory tract congestion, Saline infusion sonogram
Clinical narrative: Had a fever of 103.9 the next day with headache, muscle aches and congestion. I'm Postmenopausal and got my period. I went to my Dr. and had blood work drawn along with an Internal Ultrasound. Saw OBGYN and had a saline infusion sonogram. Results were inconclusive. Went to Endocrinologist and had a scan of my Thyroid, no nodules were found. Have been menstruating regularly ever since this dose. In 06/2022 I got a weird rash on my right wrist and started feeling bad again with a headache, fever and congestion. Had more blood work drawn, and tests were inconclusive. In 08/2022 had a severe heavy period. On 09/26/2022 am going to have my Uterus scraped and taken biopsies if needed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid gland scan normal, Ultrasound scan normal
Clinical narrative: Had a fever of 103.9 the next day with headache, muscle aches and congestion. I'm Postmenopausal and got my period. I went to my Dr. and had blood work drawn along with an Internal Ultrasound. Saw OBGYN and had a saline infusion sonogram. Results were inconclusive. Went to Endocrinologist and had a scan of my Thyroid, no nodules were found. Have been menstruating regularly ever since this dose. In 06/2022 I got a weird rash on my right wrist and started feeling bad again with a headache, fever and congestion. Had more blood work drawn, and tests were inconclusive. In 08/2022 had a severe heavy period. On 09/26/2022 am going to have my Uterus scraped and taken biopsies if needed.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Somnolence
Clinical narrative: Quite extreme fatigue for several hours. I fell asleep for about 3 hours.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Chills, Headache, Hypersomnia, Injection site erythema
Clinical narrative: Red at injection site, warm and sore to touch, with redness progressing 4 inches down arm.  Chills to the point of shivering for 48 hours. Temperature of 2 degrees above normal range for me. Severe headache at base of skull and between eyes and sensitivity to bright light lasting 48 hours. Was able to stay awake for 12 hours after the shot before symptoms started, then unable to stay awake for more than 7 hours during those 48 hours of symptoms.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site warmth, Photophobia
Clinical narrative: Red at injection site, warm and sore to touch, with redness progressing 4 inches down arm.  Chills to the point of shivering for 48 hours. Temperature of 2 degrees above normal range for me. Severe headache at base of skull and between eyes and sensitivity to bright light lasting 48 hours. Was able to stay awake for 12 hours after the shot before symptoms started, then unable to stay awake for more than 7 hours during those 48 hours of symptoms.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Dyspepsia, Skin tightness
Clinical narrative: My wrist on my right arm (the one I got the shot in) feels a bit tight in my veins. It hurts sometimes when I suddenly twist my wrist. It started happening several hours after injection. I also had some mild heartburn a couple hours after the shot, but I have not had any since.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Gait disturbance, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: Severe multiple joint pain that felt like someone took a bat to each joint. Lymph nodes at neck, armpits, elbows,groin, and knees, swollen and tender. Headache . Feeling forgetful.  The first 3 days were bad. I stayed in bed, needed a cane to walk to the bathroom.  Symptoms lessening each day, but persist still to this day .  Today, difuse shingles rash appeared.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Memory impairment, Walking aid user
Clinical narrative: Severe multiple joint pain that felt like someone took a bat to each joint. Lymph nodes at neck, armpits, elbows,groin, and knees, swollen and tender. Headache . Feeling forgetful.  The first 3 days were bad. I stayed in bed, needed a cane to walk to the bathroom.  Symptoms lessening each day, but persist still to this day .  Today, difuse shingles rash appeared.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported.; accidently administered VARIVAX intramuscularly instead of subcutaneously; This spontaneous report was received from a pharmacist referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 24-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W012166, expiration date: 12-APR-2024 for prophylaxis (dose and strength was not provided) administered intramuscularly instead of instead of subcutaneously (incorrect route of product administration). No additional adverse event was reported (no adverse event).