chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Bradycardia, Chest X-ray, Chills, Electrocardiogram
Clinical narrative: February 2, 2023, my vision turned into a kaleidoscope. The doctor advised me to go to the ER. I was told I was having an ocular migraine. On February 14, 2023, I could feel my heart beating very heavy. I had another ocular migraine the next day. I got a chill over me and getting a headache and was feeling shaky. I tried to take my blood pressure. I called the ambulance and went to the emergency department. They found bradycardia. My heart rate was down to 46 beats per minute. I was given a monitor for a week on my heart. It showed I am having heart palpitations. I have an appointment with a cardiologist at the end of April.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Ophthalmic migraine, Palpitations, Tremor, Visual impairment
Clinical narrative: February 2, 2023, my vision turned into a kaleidoscope. The doctor advised me to go to the ER. I was told I was having an ocular migraine. On February 14, 2023, I could feel my heart beating very heavy. I had another ocular migraine the next day. I got a chill over me and getting a headache and was feeling shaky. I tried to take my blood pressure. I called the ambulance and went to the emergency department. They found bradycardia. My heart rate was down to 46 beats per minute. I was given a monitor for a week on my heart. It showed I am having heart palpitations. I have an appointment with a cardiologist at the end of April.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Blood test, Chest X-ray, Computerised tomogram, Sleep disorder
Clinical narrative: I woke up at about 1AM with abdominal pain and ended up going to the ER. They did blood work and a CT scan thinking it was maybe an appendicitis. They wanted to do a surgery but I needed to get home as I was traveling. I did not do the surgery, but I have had this pain still. I have been working with providers to find out what is going on.  We have ruled out broken ribs, ongoing appendicitis, kidney stone, pneumonia, and my gallbladder. My providers think it may be muscular or skeletal because we have ruled out any issue with any internal organs.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ultrasound scan
Clinical narrative: I woke up at about 1AM with abdominal pain and ended up going to the ER. They did blood work and a CT scan thinking it was maybe an appendicitis. They wanted to do a surgery but I needed to get home as I was traveling. I did not do the surgery, but I have had this pain still. I have been working with providers to find out what is going on.  We have ruled out broken ribs, ongoing appendicitis, kidney stone, pneumonia, and my gallbladder. My providers think it may be muscular or skeletal because we have ruled out any issue with any internal organs.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Laboratory test, Palpitations, Ventricular extrasystoles
Clinical narrative: I developed heart palpitations, I immediately noticed my blood pressure going up. I contacted my doctor and went in and changed up my medication. In December I went into urgent care and my blood pressure was really high. I was having PBC's and they were happening frequently. I was given a shot but it didn't help anything, everything was still high and I was admitted into the hospital. As of now my blood pressure has become more stable but I'm still experiencing PBC.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: I very much doubt my health event had anything to do with the vaccine since it started so long after receiving the vaccine especially since it was the fourth one I had, but I noted it on my checkup anyway just to be accurate about my current health.   Health event was that my skin became extremely itchy all over my body with no visible rash for about three months. Was prescribed hydroxyzine, given a steroid shot, and have changed out all soaps for non-allergenic ones and condition has improved. Much more likely this health event was a newfound allergy, not a reaction to a vaccine I received half a year ago.
Age: 68.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Started feeling congested and feverish and was coughing a lot. On 02/27/2023 took home COVID-19 test and it was positive. Called doctor and was prescribed PAXLOVID. Tested negative on 03/07/2023.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: COVID-19, Cough, Fatigue, Headache, Respiratory tract congestion
Clinical narrative: I had a very slight very, severe headache, running nose, head congestion, fatigue, and cough. I tested positive for COVID-19 using an at home test. When I spoke to my doctor, they prescribed me Paxlovid. I tested negative and started feeling better 01/05/2023. I rebounded and tested positive for COVID-19 on 1/11/2023. I had the same symptoms with the same intensity and duration. I called y doctor again and I just ended up taking Mucinex to help with the symptoms. I didn?t test negative again until the 17th or 18th of January.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a very slight very, severe headache, running nose, head congestion, fatigue, and cough. I tested positive for COVID-19 using an at home test. When I spoke to my doctor, they prescribed me Paxlovid. I tested negative and started feeling better 01/05/2023. I rebounded and tested positive for COVID-19 on 1/11/2023. I had the same symptoms with the same intensity and duration. I called y doctor again and I just ended up taking Mucinex to help with the symptoms. I didn?t test negative again until the 17th or 18th of January.
Age: 31.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Neck mass, Ultrasound scan
Clinical narrative: In late December I found two lumps on the back of my neck. I called my primary care physician who ordered an ultrasound of the lumps. I had this done on March13, 2023. the results came back inconclusive. I will be having a biopsy of the lumps on March 23, 2023.
Age: 82.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Fatigue, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: I had my vaccination on 09/16/2022. I started to feel fatigue and nasal congestion on 02/02/2023. I went to the emergency room on 02/04/2023 and tested COVID-19 Positive. The symptoms lasted for 4 days with no course of treatment.
Age: 59.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, Headache, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: I had a runny nose and a sore throat for quite a while. I tested myself for COVID-19 and was negative. My symptoms got worse, and I developed body aches and headaches. I tested again and it was positive. It lasted for 11 days. I tested four more times and was positive each time. I finally tested negative on 01/02/2023. I had a tele visit with my doctor the day before I tested positive. I had the appointment because I had red eyes. They were not irritated, but just red. She prescribed something for my eyes, but I did not require any treatment for the COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had a runny nose and a sore throat for quite a while. I tested myself for COVID-19 and was negative. My symptoms got worse, and I developed body aches and headaches. I tested again and it was positive. It lasted for 11 days. I tested four more times and was positive each time. I finally tested negative on 01/02/2023. I had a tele visit with my doctor the day before I tested positive. I had the appointment because I had red eyes. They were not irritated, but just red. She prescribed something for my eyes, but I did not require any treatment for the COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dysphagia, Fatigue, Headache, Pyrexia
Clinical narrative: In the afternoon of 2/22/2023, I started to feel congestion in my head. I developed a headache. I had postnasal drip. I had some trouble swallowing. I did not feel any symptoms from my upper chest down. All of my symptoms were concentrated in my upper chest, throat, and head. On the morning of 2/23/2023, I had a low-grade fever. During my illness, the fever never reached above 99.6. On 2/23/2023, I went to an urgent care at about 8:30 AM and got a positive result on a PCR test. As soon as I got the positive result, I called my PCP's office, and I was prescribed PAXLOVID, and I began taking the first dose that evening. After about the third day, I started to feel better. By the time I finished taking the last dose of the PAXLOVID, which was on the morning of 2/28/2023, I felt 90% better. During my illness, I took 500 mg of OTC TYLENOL twice a day in conjunction with the PAXLOVID. I also took ROBITUSSIN CF twice a day. When I finished my PAXLOVID on 2/28/2023, I also ceased taking the TYLENOL and ROBITUSSIN CF. I felt about 90% better, but I also felt drained after dealing with the illness. On 3/1/2023 and 3/3/2023, I took home antigen tests, and both yielded negative results. On 3/4/2023, I resumed all normal activities. I would also like to add that I never lost my sense of taste or smell during my breakthrough case.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Upper-airway cough syndrome, Vaccine breakthrough infection
Clinical narrative: In the afternoon of 2/22/2023, I started to feel congestion in my head. I developed a headache. I had postnasal drip. I had some trouble swallowing. I did not feel any symptoms from my upper chest down. All of my symptoms were concentrated in my upper chest, throat, and head. On the morning of 2/23/2023, I had a low-grade fever. During my illness, the fever never reached above 99.6. On 2/23/2023, I went to an urgent care at about 8:30 AM and got a positive result on a PCR test. As soon as I got the positive result, I called my PCP's office, and I was prescribed PAXLOVID, and I began taking the first dose that evening. After about the third day, I started to feel better. By the time I finished taking the last dose of the PAXLOVID, which was on the morning of 2/28/2023, I felt 90% better. During my illness, I took 500 mg of OTC TYLENOL twice a day in conjunction with the PAXLOVID. I also took ROBITUSSIN CF twice a day. When I finished my PAXLOVID on 2/28/2023, I also ceased taking the TYLENOL and ROBITUSSIN CF. I felt about 90% better, but I also felt drained after dealing with the illness. On 3/1/2023 and 3/3/2023, I took home antigen tests, and both yielded negative results. On 3/4/2023, I resumed all normal activities. I would also like to add that I never lost my sense of taste or smell during my breakthrough case.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PT WAS GIVEN COVID19 VACCINE THAT EXPIRED ON 3/14/23.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Rash, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Late on 12/28/22, I was kind of stuffy, I wasn't running a fever. My daughter called to let my husband and I know that four out the five in her house were positive for COVID-19. I took a home COVID-19 test on 12/29/22, it came back positive. I called my doctor, to let them know I had tested positive. I had a telehealth visit and was prescribed PAXLOVID. I was on day three of the PAXLOVID, I noticed I was getting a rash all over my body that was itchy. I called the doctor and was instructed to stop the medication just in case it was the PAXLOVID. I was starting to feel better with the PAXLOVID, but then it felt like the COVID19 came back with a vengeance. It took two weeks for me to start feeling better.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Exposure to SARS-CoV-2, Malaise, Pyrexia
Clinical narrative: Started having fever and chills after being exposed to friend who had COVID-19. Took a home COVID-19 test and was positive. Contacted doctor and was prescribed PAXLOVID. Started feeling better and tested negative for COVID-19. Then 1 week later felt sick again and tested positive for COVID-19.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Started having fever and chills after being exposed to friend who had COVID-19. Took a home COVID-19 test and was positive. Contacted doctor and was prescribed PAXLOVID. Started feeling better and tested negative for COVID-19. Then 1 week later felt sick again and tested positive for COVID-19.
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Tremor
Clinical narrative: Patient started to feel dizzy moments after vaccination. Mom stated he didn't like needles. Patient then started feeling shaky .  I informed the ordering physician and obtained vitals . We also checked patients bs and everything was in normal range. Mom and patient sat in the clinic about 20 more minutes and I wheeled patient to his moms vehicle. Patient was communicating and stated he felt a lot better after getting some fresh air. Mom stated she would look after him . Mom is a Nurse
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Vaccination site discolouration
Clinical narrative: Lingering painful headaches; lethargy; exhaustion; discoloration at the injection site where the bandaid was.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Mar2023 at 12:00 as dose 5 (booster), single (Lot number: GJ6742) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; ATORVASTATIN; FLUOXETINE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, lot number and expiration date not provided.), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered", described as "Lingering painful headaches"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered", described as "discoloration at the injection site where the bandaid was."; FATIGUE (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered", described as "exhaustion"; LETHARGY (non-serious) with onset 08Mar2023 at 16:00, outcome "not recovered". Therapeutic measures were not taken as a result of headache, lethargy, fatigue, vaccination site discolouration.  Additional Information: It was reported that no  allergies and no other vaccination was taken in four weeks. There was no COVID prior vaccination and COVID was not tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: rash on my arm; shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , lot number and expiration date: not provided), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash on my arm"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". The events "rash on my arm" and "shingles" required physician office visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110146 same patient/drug, different dose number/event;US-PFIZER INC-202300111130 same patient/drug, different dose number/event;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: still got COVID virus; still got COVID virus; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 71 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Lot number: 039K20A), on 11Feb2021 as dose 2, single (Lot number: 030M20A), on 07Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 24Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "still got COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Mar2023) negative, notes: next day on Friday, which was her day 10, she tested negative; (14Mar2023) Positive, notes: Today, she had things to do and decided to do home test and did 2 and both were positive; (14Mar2023) Positive, notes: Today, she had things to do and decided to do home test and did 2 and both were positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: All were Moderna except last one was Pfizer. She needed to get glasses to see them. 3rd dose Moderna COVID vaccine booster, 07Sep2021, Lot 107E and either 2 or z, then 1A. It looks like a Z but not certain. Expiration is unknown. Product strength and count size dispensed: not provided. Additional lot numbers: none. Patient mentioned on this report that she previously had all of the COVID vaccines listed below and still got COVID virus. She took last dose of Paxlovid last Thursday morning and next day on Friday, which was her day 10, she tested negative.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose number unknown, single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional extrasystoles" (unspecified if ongoing), notes: Occasional extrasystoles. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2023) Positive, notes: Day zero was the day I developed symptoms and had a positive antigen and PCR test; (11Mar2023) Negative, notes: My rapid antigen test was negative on day six; (12Mar2023) Negative, notes: My rapid antigen test was negative on day seven; (13Mar2023) Positive, notes: turned positive on day eight. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The rapid antigen test was negative on day six and seven but turned positive on day eight. Day zero was the day he developed symptoms and had a positive antigen and PCR test. His symptoms lasted about 24 hours and were mild. This was what is conventionally called a Paxlovid rebound. Known allergies: O.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness
Clinical narrative: I got sick with every single shot (Pfizer COVID-19 Vaccine); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disorder" (unspecified if ongoing), notes: Synthroid is what I take for my thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Bnt162b2 (Dose: 01, single, I got sick with every single shot (Pfizer COVID-19 Vaccine)), for COVID-19 Immunization, reaction(s): "I got sick with every single shot (Pfizer COVID-19 Vaccine)". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I got sick with every single shot (Pfizer COVID-19 Vaccine)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported patient had the first two dose during Covid then had the booster then just had the last booster that was offered the one that just came out and patient got sick with every single shot (Pfizer COVID-19 Vaccine). Patient took some vitamins.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112514 same patient/drug, different dose;
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Head discomfort
Clinical narrative: felt like liquid running through to her head; lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 15Mar2023 at 10:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years, in right arm for immunisation. The patient's relevant medical history included: "Covid", start date: 2022 (unspecified if ongoing), notes: She had been in the hospital for 9 weeks for Covid in 2022 at the beginning of the year; "Covid", start date: 2022 (unspecified if ongoing), notes: had it again at the end of the year and didn't go to the hospital for that one.; "disabled" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: B12 shot. Vaccination history included: Pneumonia shot (pneumonia shot previously about 6 years ago in the hospital), administration date: 2017, when the patient was 79 years old, for Immunization. The following information was reported: HEAD DISCOMFORT (non-serious) with onset 15Mar2023, outcome "recovering", described as "felt like liquid running through to her head"; DIZZINESS (non-serious) with onset 15Mar2023, outcome "not recovered", described as "lightheaded". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: All of a sudden, she felt like it was going through to her head and running like it was the most, she has never in all the years she has had injections never had an experience like this. She felt like liquid running through to her head. States it has passed. Still lightheaded but not anywhere near what she felt like something was just running into her head. Never experienced that in all her 84 and half years. She takes her usual medications. Event did not require a visit to emergency room or physician office.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure abnormal, Blood pressure measurement
Clinical narrative: had a dose of the Pfizer covid 19 vaccine but ended up in the ER with a small intestine issue; She also mentioned she takes a blood pressure pill.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "had a dose of the Pfizer covid 19 vaccine but ended up in the ER with a small intestine issue"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "She also mentioned she takes a blood pressure pill.". The event "had a dose of the pfizer covid 19 vaccine but ended up in the er with a small intestine issue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure abnormal.  Additional Information: The caller shared also that she had a dose of the Pfizer COVID 19 vaccine but ended up in the ER with a small intestine issue. After the first vaccination of the COVID Vaccine she was in the emergency department with small intestine issue. She also mentioned she takes a blood pressure pill.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation.The patient's relevant medical history included: "known allergies sulpha drugs" (unspecified if ongoing), notes: known allergies sulpha drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2022 at 10:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that patient had no known allergies. The patient had COVID-19 treatment with Paxlovid from 08Mar2023 to 12Mar2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118889 Same patient, same reporter, different product, different events;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown), in right arm and in Oct2022 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "emphysema" (unspecified if ongoing); "copd" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. There were no concomitant medications. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset Oct2022, outcome "not recovered", described as "Inappropriate schedule of vaccine administered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Currently on 15 days post positive Covid test; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. On 15 days post positive Covid test and, the patient was still very symptomatic.: lost taste and smell on day 14 and also Congestion, mild sore throat, lymph nodes tender near upper breast and underarms, fatigue, light headedness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Rash
Clinical narrative: Allergy; rash; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): NUS2023US038615_OS (RA).  A 55-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy"; RASH (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Allergy to vaccine, Rash, Urticaria
Clinical narrative: experiencing an new allergy to the covid bivalent pfizer shot; hives; rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023SA054066 (Sanofi).  A 29-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Oct2022 (Batch/Lot number: unknown) at 300 mg weekly, subcutaneous for eosinophilic oesophagitis. The patient's relevant medical history and 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "experiencing an new allergy to the covid bivalent pfizer shot"; URTICARIA (non-serious), outcome "unknown", described as "hives"; RASH (non-serious), outcome "unknown". The action taken for dupilumab was unknown.  Additional information: It was reported "since the last fill experiencing an new allergy to the covid bivalent Pfizer shot, patient got hives and a rash". it is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. it is unknown if there were lab data/results available." It was not reported if the patient received a corrective treatment for the events (experiencing an new allergy to the covid bivalent Pfizer shot, hives, rash).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Chills; Headache; Sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB being administered to a patient with no reported advesre event; Initial information received on 14-Mar-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 12 months old female patient who used expired dose of acthib being administered to a patient with no reported advesre event after receiving vaccine hib (prp/t) vaccine [Act-Hib].   The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On an unknown date, the patient received suspect hib (prp/t) vaccine (strength, dose, frequency, formulation, route, : unknown) (lot UJ649AAA, Expiry date: 05-Mar-2023) in unknown administration site for prophylactic vaccination (immunization).  On 13-MAR-2023 the patient diagnosed with a non-serious expired dose of acthib being administered to a patient with no reported advesre event (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose of ACTHIB with an expired diluent were administered with no reported adverse event; Initial information received on 15-Mar-2023 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 15 months old female patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with an expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Mar-2023, the patient received an expired Booster dose of 0.5 mL of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Strength: standard) (lot: UJ649AAA; expiry date: 05-Mar-2023 ) via intramuscular route in the right thigh with an expired diluent with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of acthib with an expired diluent were administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA085856:01533896
Age: 1.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Expired product administered
Clinical narrative: An ACTHIB diluent was expired, and the powder was good. It was given to two patients after the expiration date with no reported adverse event; Initial information was received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 1 years old female patient who stated an acthib diluent was expired, and the powder was good. it was given to two patients after the expiration date with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 14-Mar-2023, the patient received 0.5 ml Total dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UJ642AA/U7247AB, expiry date: 27-Mar-2023/ 02-Mar-2023) (strength was unknown) via intramuscular route in Left thigh for Immunization.  On 14-Mar-2023 the patient developed a non-serious event of an acthib diluent was expired, and the powder was good. it was given to two patients after the expiration date with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACTHIB diluent was expired, and the powder was good (with no reported adverse event); Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2023SA087047.  This case involves a 1 years old male patient and reporter reported Hib (Prp/T) Vaccine [Act-Hib] diluent was expired, and the powder was good (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Immunization.  On 06-Mar-2023, the patient received 0.5 ml Total dose of suspect Hib (Prp/T) Vaccine Powder and solvent for solution for injection (lot number: UJ642AA, Expiry date: 27-Mar-2023; Diluent) (lot number: U7247AB, Expiry date: 02-Mar-2023;Powder) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for immunization.  On 06-Mar-2023, the reporter reported Hib (Prp/T) Vaccine diluent was expired, and the powder was good (with no reported adverse event) (expired product administered) (latency: same day).  It was reported, It was given to two patients after the expiration date.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib diluent was expired, and the powder was good (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received a dose of Daptacel that expired on 01Mar2023 with no adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case from a physician.  This case involves a patient of unknown age and gender who received a dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that expired on 01-Mar-2023 with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Mar-2023, the patient received suspect diphtheria-15/tetanus/5 AC pertussis vaccine suspension for injection at a dose of 0.5 ml once (lot C5829BA, expiry date: 01-Mar-2023) via unknown route in unknown administration site for immunization.  On 16-Mar-2023 the patient received a dose of daptacel that expired on 01-Mar-2023 with no adverse event (expired product administered, latency: same day).  It was reported that that most vaccines only have a month and year listed for the expiry date, and that having the date listed also with a day contributed to the error because the person wasn't paying close enough attention. He did not have time to provide additional details, saying that he must see the next patient. He stated that he would have to have his nursing supervisor call back with more details. He then abruptly disconnected the call.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Body aches, headache, fatigue for 2 days starting after booster.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: Evening of 2/12 it started with a scratchy throat, and the next day I woke up with a runny nose.  I got tested at pharmacy with PCR, Positive.  Televisit with Doctor who proscribed Paxlovid and maintain vigilance on Oxygen saturation.  Symptoms diminished to nothing within 24 hours of starting Paxlovid.  Dry cough lingers occasionally.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Lymph node pain, Myalgia, Nasopharyngitis
Clinical narrative: I felt like I had a cold, but my throat wasn't sore or tender. It was like the lymph nodes and muscles in my neck were sore. Whenever I woke up, it was especially sore in my neck after having slept all night, but after I sat up for a while, the soreness subsided, and it then just felt like a cold afterwards. I was taking Advil for a fractured wrist at this time, so that may have helped, also. I tested positive for COVID-19 on 1/31/2023. I then tested negative for COVID-19 on 2/10/2023. After I tested negative, I developed a runny nose and a  bit of a cough. Whenever I had the cough, I just sucked on a hard candy to relieve it, because was caused mainly by drainage.  When I contacted my GP, I was not prescribed anything. During my time with the breakthrough case, I didn't feel really bad. I just continued taking my usual OTC medicines like Flonase, Zyrtec, and Advil.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck pain, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection, Wrist fracture
Clinical narrative: I felt like I had a cold, but my throat wasn't sore or tender. It was like the lymph nodes and muscles in my neck were sore. Whenever I woke up, it was especially sore in my neck after having slept all night, but after I sat up for a while, the soreness subsided, and it then just felt like a cold afterwards. I was taking Advil for a fractured wrist at this time, so that may have helped, also. I tested positive for COVID-19 on 1/31/2023. I then tested negative for COVID-19 on 2/10/2023. After I tested negative, I developed a runny nose and a  bit of a cough. Whenever I had the cough, I just sucked on a hard candy to relieve it, because was caused mainly by drainage.  When I contacted my GP, I was not prescribed anything. During my time with the breakthrough case, I didn't feel really bad. I just continued taking my usual OTC medicines like Flonase, Zyrtec, and Advil.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reaction. medication not appropriate for patient's age
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bacterial infection, Biopsy bone marrow abnormal, COVID-19, Condition aggravated, Death
Clinical narrative: He did not have any symptoms of COVID-19. His leukemia was acting up so we went to the hospital. They did test and he tested positive for COVID-19. He was in the hospital for 5 days and I don't know if they gave him any medication for COVID-19.  They did a bone marrow biopsy and found out his leukemia was getting worst. He developed a bacteria infection and past away.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Leukaemia, SARS-CoV-2 test positive
Clinical narrative: He did not have any symptoms of COVID-19. His leukemia was acting up so we went to the hospital. They did test and he tested positive for COVID-19. He was in the hospital for 5 days and I don't know if they gave him any medication for COVID-19.  They did a bone marrow biopsy and found out his leukemia was getting worst. He developed a bacteria infection and past away.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: Started having sinus problems and a cough. Took a home COVID-19 test and was positive. Spoke to doctor but wasn't prescribed anything. Still recovering.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Computerised tomogram, Coronary arterial stent insertion, Electrocardiogram, Myocardial infarction
Clinical narrative: I had a heart attack and a stent was placed in my right circumflex.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: I had a heart attack and a stent was placed in my right circumflex.