chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Fall, SARS-CoV-2 test positive
Clinical narrative: Date of Admission: 5/29/2023  Discharge Date:  June 7, 2023 Discharge Disposition: Inpatient Rehab Facility or Unit  Presented to the hospital after a fall.   5/30 COVID+ Does not have any respiratory symptoms.  Afebrile, no leukocytosis, no respiratory distress or hypoxia. No need for respiratory medications, antivirals or steroids. EN5318 2/3/2021 EN6201 2/25/2021 33030BD 12/6/2021 GJ2524 9/23/2022
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to right deltoid injection site. Dr came in to see patient. Cephalexin and Benadryl prescribed to local pharmacy. Return 2 days for reevaluation.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoxia
Clinical narrative: R09.02 HYPOXEMIA 4/3/2023 CHEST PAIN R09.02 HYPOXEMIA 4/3/2023 CHEST PAIN
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac stress test normal, Disorientation, Dizziness, Dysarthria
Clinical narrative: heart arrythmia, unexplained positional drop in BP, dizziness, disorientation, mild difficulty articulating.  Started a couple of weeks after receiving vaccine.  Went to Dr, then to ED.  had stress test and MRI.  found nothing wrong with heart.  Believed to be neurological.  Lasted until about 10/2022.  went away fairly rapidly.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Magnetic resonance imaging head, Orthostatic hypotension
Clinical narrative: heart arrythmia, unexplained positional drop in BP, dizziness, disorientation, mild difficulty articulating.  Started a couple of weeks after receiving vaccine.  Went to Dr, then to ED.  had stress test and MRI.  found nothing wrong with heart.  Believed to be neurological.  Lasted until about 10/2022.  went away fairly rapidly.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac arrest, Death, Multiple organ dysfunction syndrome, SARS-CoV-2 test positive
Clinical narrative: Date of Admission: 6/2/2023  Discharge Date: 6/2/2023 Discharge Disposition: deceased COVID+ 6/2 presented to the ED - witnessed cardiac arrest due to multisystem organ failure.  037A21B 3/25/2021 045B21A 4/27/2021 939909 11/22/2021
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure acute, Hypoxia, Left ventricular failure
Clinical narrative: HYPOXIA 4/13/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hyponatraemia, Hypoxia, Respiratory failure
Clinical narrative: J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/17/2023 HYPONATREMIA R09.02 HYPOXIA 4/25/2023 HYPONATREMIA
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angioedema
Clinical narrative: ANGIOEDEMA, INIT ANGIOEDEMA, SEQUELA
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash erythematous, Skin warm, Swelling
Clinical narrative: red, warm to touch, swollen rash
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Pfizer 3/18/2021 (no lot #), 4/8/21 EW0150, 11/23/2021 FH8027 and bivalent 9/19/2022 FJ2524
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA HYPOXIA 1/31/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Epidural injection, Spinal stenosis
Clinical narrative: Epidural injection related to spinal stenosis... not related to covid or covid virus
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic aneurysm, COVID-19, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: I am sensitive to the vaccine and was out of work for three days just not feeling good. I had a fever, fatigued and body aches. I tested in COVID-19 in 01/2023. I was too far into being sick and unable to get a prescription. I was monitored at the emergency room due to having difficulty breathing. I had test ran and at that time I was diagnosed with an aortic aneurysm. As of today, I feel better from COVID-19 with no lingering symptoms. I am taking medication for my heart.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test abnormal, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I am sensitive to the vaccine and was out of work for three days just not feeling good. I had a fever, fatigued and body aches. I tested in COVID-19 in 01/2023. I was too far into being sick and unable to get a prescription. I was monitored at the emergency room due to having difficulty breathing. I had test ran and at that time I was diagnosed with an aortic aneurysm. As of today, I feel better from COVID-19 with no lingering symptoms. I am taking medication for my heart.
Age: 20.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia, Symptom recurrence
Clinical narrative: HYPOXIA 10/30/2022,  1/2/2023,  11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA 5/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Per patient, only slight soreness on the arm. No other side effects.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: lethargy, inconsolable,  and fever up to 101 F for 2 days. Tenderness, redness, swelling at site for 1 week.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: lethargy, inconsolable,  and fever up to 101 F for 2 days. Tenderness, redness, swelling at site for 1 week.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Patient's mother called to report diarrhea 24 hours post vaccination.  Patient has taken pepto-bismol and imodium, but the diarrhea persists.  She called the doctor and was told to call the pharmacist.  Patient reported no fever  nor changes in routines or diets.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Trigger finger, X-ray
Clinical narrative: It was the next morning I woke up with a severe excruciating headache and ten trigger fingers. It lasted for two weeks before I finally called my doctor and was referred to specialists first my Ophthalmologist, ENT, Neurologist, a hand surgeon and a Rheumatologist. The trigger fingers subsided to a few days a week as did the headaches.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Pain
Clinical narrative: Patient is feeling sore and a little tired the day after but that could be due to getting Twinrix and Ipol vaccines together per patient request.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Paraesthesia oral, Pruritus, Swelling
Clinical narrative: patient c/o lips tingling, itching and swelling which started evening after receiving vaccine./ evaluated by provider in office on 6/22/23 and given RX for Prednisone 40mg daily x 7 days. Provider does not think symptoms are related to vaccine but report filled out just to be safe.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fall, Flushing
Clinical narrative: told mom to wait 5-10 minutes make her she does not have a reaction as I (MA) was leaving she got really flushed and fell over. She did not hit anything off the floor, mom caught her. I (MA) ran to get provider to come check on her. Spo2 was taken 97 and blood pressure was taken 88/60  gave water/juice/and a snack  had her lay down
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MMR was administered too soon after another live vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19-2, HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient initiated Pfizer COVID series in the 6 months through 4 years age group. Patient is required to complete series in that age group. Patient inadvertently received Pfizer 5-11 Bivalent vaccine as patient was 5 years old at time of vaccination. Patient will complete <5 COVID series with third dose being <5.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Blood test, COVID-19, Cardiac monitoring abnormal, Cardiac valve disease
Clinical narrative: She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Echocardiogram abnormal, Facial pain
Clinical narrative: She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, Heart rate increased, Impaired driving ability, Malaise, Pain in jaw
Clinical narrative: She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Rash, Secretion discharge, Skin discolouration
Clinical narrative: She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation, Skin warm, Sleep disorder, Throat clearing, Thrombosis
Clinical narrative: She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: She got her vaccine at a drive through area.  The next day she noticed that she had two boils on her face, one on her forehead near the hairline and one inside her nose.  A few days later she had a blood clot in her eye, blood over her left eye.  It went away and she did not go to a doctor as she felt there was nothing they could do.  Then she noticed that she had coughing, a lot of mucous and trouble breathing, and constantly clearly her throat.  A few months later she noticed that she has a racing heartbeat.  She didn't think about it until she went to the doctor and he informed her that she may have an enlarged heart.  They did an echocardiogram which showed that she had an enlarged valve.  They want her to do an MRI as she is allergic to the contrast material, and she wore the monitor.  That showed that it was not serious as sometimes it was short and sometimes it goes away.  It seems that is more at nighttime.  She notices that she is starting to have more racing heartbeat.  Her doctor gave her some medicine to take only when she really needed it and to do some exercises.  She has been having a lot of pain on her cheeks and her jaw, and she has not been paying much attention to other stuff.  Otherwise she is very healthy.  States that she got hacked, but was always on the go as a realtor.    She tries not to take the medicine if she does not need it, but she notices that her heart is running fast, speeding and then it goes away after about 15-20 times.  She feels her heart beating on her stomach and on her chest.  She also severe joint pain, and has had COVID twice with vomiting and dizziness.  She was traveling and had to check into a hotel for 3 days as she was too sick and dizzy to drive.    She also had a severe rash under her hairline, behind her neck, behind her ears, mini blisters in her head nonstop and could not sleep for a month as she itched nonstop.  She went to a dermatologist 3 times and her PCP 3 times to get medications.  It was then all over her body and back, and would go away and then come back.  She has a patch of blisters on her back, and sometimes on her elbows has a blister area.  Her skin gets real hot and when she lies down it is more irritated, and she continues to have that issue and is on 5-6 prescriptions to treat it.    She was getting better and then got the 2nd vaccine Moderna and still continues to have the rash.  She has brown spots all over her body, stomach, arms, legs, thighs.  All different sizes which happened about the same time as the rashes.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Crying, Musculoskeletal stiffness, Opisthotonus, Screaming
Clinical narrative: Child became very stiff and unable to console at times. He would ball his hands and fists tightly and just scream while arching his back. As parents we could not do anything to help him during these moments he would just scream until he fell asleep. This lasted for several weeks post vaccine.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Crying, Musculoskeletal stiffness, Screaming
Clinical narrative: Child became very stiff and unable to console at times. He would ball his hands and fists tightly and just scream while arching his back. As parents we could not do anything to help him during these moments he would just scream until he fell asleep. This lasted for several weeks post vaccine.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Chills, Fatigue, Hypoaesthesia, Pain
Clinical narrative: Client's mother called 4 hours after vaccine administration to state client was feeling fatigued, body aches, low grade fever with chills, back pain and numbness sensations in legs.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Client's mother called 4 hours after vaccine administration to state client was feeling fatigued, body aches, low grade fever with chills, back pain and numbness sensations in legs.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Symptom recurrence, Viral pericarditis
Clinical narrative: VIRAL PERICARDITIS ACUTE PULMONARY EMBOLISM 1/2/2023 --RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Cough, Muscle spasms, Nasal congestion, Oropharyngeal pain
Clinical narrative: After I received the vaccine, my arm swelled for about three days and hurt. In 01/2023, I began having spasms in my back and I thought I was constipated. I drank lots of fluids and eventually felt better. I developed a cough that lasted for several weeks. In 04/2023, I had a very bad sore and red throat. I tested negative for COVID-19. I have had a lot of nasal congestion and drainage. As of today, I continue to have random days of my throat burning and congestion.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pharyngeal erythema, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: After I received the vaccine, my arm swelled for about three days and hurt. In 01/2023, I began having spasms in my back and I thought I was constipated. I drank lots of fluids and eventually felt better. I developed a cough that lasted for several weeks. In 04/2023, I had a very bad sore and red throat. I tested negative for COVID-19. I have had a lot of nasal congestion and drainage. As of today, I continue to have random days of my throat burning and congestion.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Throat irritation
Clinical narrative: After I received the vaccine, my arm swelled for about three days and hurt. In 01/2023, I began having spasms in my back and I thought I was constipated. I drank lots of fluids and eventually felt better. I developed a cough that lasted for several weeks. In 04/2023, I had a very bad sore and red throat. I tested negative for COVID-19. I have had a lot of nasal congestion and drainage. As of today, I continue to have random days of my throat burning and congestion.
Age: 66.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Patient presents to clinic with red rash estimated 4x2inch rash on right deltoid. History as follows:  Vaccine given 06/16/2023. Tenderness noted at right deltoid from 16th - 21st  06/21/2023 afternoon noted small, non-discolored bumps at the site. Itchiness at site. Patient applied cortisone cream at home and this helped.  Today patient noted red rash of 4x2 inch area. Bumps resolved. Outside of wound is itchy. Whole arm aches. site is tender. Kenalog cream and claritin oral ordered.
Age: 66.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Pain in extremity, Wound
Clinical narrative: Patient presents to clinic with red rash estimated 4x2inch rash on right deltoid. History as follows:  Vaccine given 06/16/2023. Tenderness noted at right deltoid from 16th - 21st  06/21/2023 afternoon noted small, non-discolored bumps at the site. Itchiness at site. Patient applied cortisone cream at home and this helped.  Today patient noted red rash of 4x2 inch area. Bumps resolved. Outside of wound is itchy. Whole arm aches. site is tender. Kenalog cream and claritin oral ordered.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Eye discharge, Pyrexia
Clinical narrative: Fever, dizziness, eye discharge
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Eye pain, Headache, Pyrexia
Clinical narrative: Fever, dizziness, eye discharge
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 2/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest
Clinical narrative: No spontaneous respirations.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered an expired dose of the bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number - 027L20A) on 07-Jan-2021, Moderna COVID-19 Vaccine (Dose 2, lot number - 012M20A) on 05-Feb-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 4, lot number FK9729) on 09-Sep-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 5 and lot number - 030G22B) on 22-Sep-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 3 and lot number 32030BD) until 30-Oct-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hypertension.    On 19-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered an expired dose of the bivalent vaccine).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Patient not had adverse events after the administration.   Dosage text was reported as unknown.  Treatment details was not reported by the reporter.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Deep vein thrombosis, Hypotension, Hypoxia
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN IATROGENIC HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave Dtap instead of Tdap.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cough, Croup infectious, Product preparation issue, Pyrexia
Clinical narrative: Patient was evaluated in the ED less than 24 hours after receiving the vaccines for sx of fever, cough. Temp noted at 100.9. Cough described as 'barky'. DX with Croup.  It was later found during routine vaccine inventory check that the Hib was not reconstituted with the supplied diluent (0.4% Sodium Chloride)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia
Clinical narrative: HYPOTENSION HYPOXEMIA
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: Boby aches, muscle aches, over all not feeling well, then started having ringing in my ears get louder and louder. I went to the ER about a week ago 6/10/23 over my heart, I blacked out, was unresponsive and shocking on my own vomit. ER diagnosis was I was in AFIB, my jaws and arm was killing me. I was treated with aspirin and various medication  then able to go home with medication. I the new  cardiologist/APN  on  6/12/23
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: Boby aches, muscle aches, over all not feeling well, then started having ringing in my ears get louder and louder. I went to the ER about a week ago 6/10/23 over my heart, I blacked out, was unresponsive and shocking on my own vomit. ER diagnosis was I was in AFIB, my jaws and arm was killing me. I was treated with aspirin and various medication  then able to go home with medication. I the new  cardiologist/APN  on  6/12/23
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Tinnitus, Unresponsive to stimuli, Urine analysis, Vomiting
Clinical narrative: Boby aches, muscle aches, over all not feeling well, then started having ringing in my ears get louder and louder. I went to the ER about a week ago 6/10/23 over my heart, I blacked out, was unresponsive and shocking on my own vomit. ER diagnosis was I was in AFIB, my jaws and arm was killing me. I was treated with aspirin and various medication  then able to go home with medication. I the new  cardiologist/APN  on  6/12/23
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/31/2022,  11/25/2022,  11/27/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given an invalid vaccine dose. NA on symptoms/signs
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine administered administered to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered administered to a patient).    No concomitant medication information was provided. It was reported that there was an instance where an expiration date was incorrectly documented for lot number 043h22a. it expired 8Jun23 but was administered to a patient 17Jun23 . Reporter was looking for guidance if the patient needs another dose or not. The vial size was reported as 2.5ml. It was unknown when the vial was initially stored in the refrigerator. It was confirmed that the vial had not undergone temperature excursion issue.  Patient had had reported any adverse event at the time of report. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2023: Follow-up received contains no new information.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, MENB
Symptoms: Wrong product administered
Clinical narrative: Child was here with mother for immunizations.  Was to receive Hep B, however, MenB was given, tolerated well without incident.  Monitored for 15 minutes.  Discussed with mother, she verbalized understanding of incident.  Was given VIS handout.  Hep B was given as required for school.  Tolerated well without incident.
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: localized red reaction at site of injection
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: PT REC'D DOSE 4/21/22, IMMUIZATION REGISTRY SHOWED THIS AS PPSV (THOUGH IT WAS PNEUMOVAX) GAVE ANOTHER DOSE 6/20/23
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: REC'D 3RD DOSE OF VACCINE
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 11.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Patient was administered expired Adacel vaccine (expiration date was 6/18/2023, administered on 6/22/2023) Patient was administered meningococcal B (bexsero) instead of meningococcal A
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 54.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Dermatitis, Rash
Clinical narrative: whole body rash
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Her arms that ache; can barely move her bangles and it is not normal; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Jun2023 at 14:00 as dose number unknown, single (Lot number: GJ6742) at the age of 53 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "need potassium in diet" (unspecified if ongoing). Concomitant medication(s) included: POTASSIUM taken for mineral supplementation; BUSPIRONE taken for anxiety (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Jun2023, outcome "unknown", described as "Her arms that ache"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 15Jun2023, outcome "unknown", described as "can barely move her bangles and it is not normal".  Additional Information: It was reported that the patient needed to knowif that was standard or normal for her arms that ache like a 'TB time' shot like that was in military. It was reported that they did not put an expiration date. Buspirone should have been taken twice a day but the patient have been taking it once a day. The patient was asked to visit healthcare professional if needed. No investigations.
Sex: U
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram venography head, Head discomfort, Headache
Clinical narrative: heavy headaches/headaches; heavy headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 3 (booster), single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 4 (booster), single; manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (dose 5 (booster), single; manufacturer unknown), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "heavy headaches/headaches"; HEAD DISCOMFORT (non-serious), outcome "not recovered", described as "heavy headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient asked to offer any advice in case these headaches were related since there's no other reason the patient could identify. Also, reported that the duration for heavy headaches was 3 days.  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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for COVID-19 immunization, reaction(s): "fever"; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for COVID-19 immunization, reaction(s): "fever"; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 immunization, reaction(s): "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Patient received COVID-19 vaccines and boosters when available (24 hour fever after each).  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.